Therapeutic strategy
Where our science
could contribute to care.
Clinical needs, established care and the questions guiding our development program.
Explore our strategyClinical-stage biopharmaceutical science
Where nature
meets next-gen
medicine™
Medikra® is a clinical-stage biopharmaceutical company developing botanical therapeutics from standardized bioactive APIs. Led by SKF7® in central adiposity and metabolic dysfunction, we connect human evidence, molecular research and commercial execution through an integrated Malaysia–United States–Korea growth strategy.
ROOTED IN MALAYSIA. ADVANCING THROUGH THE UNITED STATES AND KOREA.
BOTANICAL COMPLEXITY.SCIENTIFIC PRECISION.Conceptual artwork · Drag to rotate · Arrow keys
Explore the scienceA scientific foundation.
A clear path forward.
A clear path forward.
3
Completed human studies
of SKF7®
3
Granted patents in Malaysia
and the United States
3
Registered products
marketed in Malaysia
Human evidence
Central adiposity.
Body composition.
Metabolic biology.
SKF7® is our lead oral botanical-drug candidate. The Malaysia Phase II study reported significant reductions in waist measures, body weight and BMI. In Indonesia, significant body-fat and reported lean-body-mass changes were observed despite no statistically significant difference in total body weight.
Human proteomics adds molecular evidence on lipid processing, mobilization and fatty-acid oxidation. Together, these findings support a development rationale that extends beyond total weight reduction.
Malaysia
Randomized Phase II
133participants
4 months
Indonesia
Randomized Phase II
120participants
3 months
India
Human pharmacokinetics
12participants
Completed
Separate studies, reported separately.
10,788
Where our science
Women’s health
Endocrine health.
Metabolic focus.
Planned SKF7® studies in PMOS and menopause-associated metabolic dysfunction.
Explore women’s healthSafety & exposure
A deeper foundation.
For the next clinical question.
Defined chemistry, human evidence and a developed safety program underpin SKF7®’s botanical-drug development. Across our pipeline, safety and pharmacokinetic studies inform exposure assessment and the next stages of investigation.
SKF7®
Long-term nonclinical studies, cardiovascular safety pharmacology and animal and human pharmacokinetics connect with three completed randomized human studies.
- Chronic rat study
- 12 months
- Chronic dog study
- 9 months
- Human studies
- 3 completed
KPH1™
Preclinical cardiovascular efficacy research, biological research and a completed GLP safety and exposure study form an integrated foundation for KPH1™’s clinical-development planning.
- Repeated-dose study
- 90 days
- Recovery period
- 28 days
Our scientific approach
Defined chemistry.
Evidence-led development.
Our standardized bioactive APIs bring together defined botanical identity, chemical-marker specifications and analytical characterization. SKF7® connects this foundation with human clinical evidence, human proteomics, safety and pharmacokinetic studies.
CharacterizeInvestigateInterpretDevelop
- Extract
- Characterize
- Standardize
SKF7®
Labisia pumila var. alata
- Gallic acid
- ≥2.0%
KPH1™
Kaempferia parviflora
- 5,7-Dimethoxyflavone
- ≥8.0%
MKS-5®
Orthosiphon stamineus
- Rosmarinic acid
- ≥1.0%
- Sinensetin
- ≥0.05%
Minimum chemical-marker specifications within standardized multicomponent APIs.
Medikra® AI Life Sciences
Connecting evidence.
Expanding possibility.
Our planned AI model connects chemistry, human evidence and molecular research to guide discovery, development and product design.
Planned operating modelSelect an application to explore
- Product chemistryComposition & consistency
- Human clinical & PKResponse & exposure
- Molecular dataProteins & pathways
- Safety & pharmacologyTolerability & biological activity
Medikra®AI Life Sciences
Multimodal scientific AI · planned model
Lab & clinical validationEvidence informs the next cycle
Discovery
Connect chemical and biological evidence to prioritize hypotheses for validation.
Development
Integrate clinical, molecular, exposure and safety findings to inform study planning.
Product design
Investigate formulations and applications of standardized bioactive APIs.
International growth
Three markets.
One integrated strategy.
Our growth strategy connects Malaysia’s scientific and commercial base with development and market opportunities in the United States and Korea.
Malaysia
Science and operations.
Clinical research, standardized API development and marketed products form our operating foundation.
United States
Development and partnerships.
FDA-facing botanical-drug development and consumer-health market entry guide our North American strategy.
Korea
Clinical and market expansion.
Regulatory development, planned women’s health studies and commercial partnerships support our next stage of growth.
Our pipeline
Distinct programs.
Shared scientific discipline.
| Program / focus | Current stage | Planned next step |
|---|---|---|
| SKF7®Central adiposity & metabolic dysfunction | Human pharmacokinetics and two randomized Phase II studies completed | Phase II/III protocol development and regulatory engagement |
| SKF7®Women’s endocrine-metabolic health | Planned clinical expansion | Develop postmenopause and PMOS study protocols with Korean investigators |
| KPH1™Cardiovascular function | Preclinical cardiovascular and molecular research; 90-day GLP toxicology and toxicokinetics completed | Phase I/II program planning |
| MKS-5®Inflammation & joint health | Preclinical research | Further efficacy and safety validation |
A broader standardized API portfolio. BR-2™, AGS-1™ and CAS-9™ extend our earlier-stage programs, each characterized against defined chemical markers.
Explore earlier-stage programsConsumer health
Science in development.
Products in market.
Labeesity SKF7®
Metabolic health & weight-management support
Pervira®
Energy, vitality & healthy-aging support
Starpril®
Joint-health & inflammation-linked support
Labeesity SKF7®, Pervira® and Starpril® are registered with Malaysia’s NPRA and commercially available in Malaysia.
Scientific record
Evidence you can explore.
Move the science forward.
Connect with our team to explore research, investment and strategic partnerships.
Science & platform
Complex chemistry.Defined science.
Our work begins with botanical complexity. We develop standardized bioactive APIs—active pharmaceutical ingredients—with defined quality attributes, then investigate their safety, biological activity and clinical potential.
Drag to inspect · Arrow keys to rotate
From source to defined API
Reproducibility is
the starting point.
An API is an active pharmaceutical ingredient. Defining what goes into it is essential to understanding what it does.
01Characterize
Know the composition.
Botanical identity, analytical characterization and marker-compound control help define the investigated product. Reproducible extract profiles and batch consistency connect the material we study to the material we develop.
02Investigate
Build evidence in sequence.
Pharmacology, toxicology and pharmacokinetics establish the basis for human investigation. Clinical studies evaluate safety, tolerability, dose response and patient-relevant outcomes. SKF7® has completed human pharmacokinetic and randomized Phase II studies.
03Interpret
Connect data to biological questions.
Proteomics, transcriptomics, metabolomics and microbiome datasets help us investigate pathways and generate hypotheses for further validation. Computational analysis and bioinformatics connect these datasets to testable biological questions. AI-enabled applications form the next stage of our analytical development.
04Develop
Advance the product and the evidence together.
Analytical control, manufacturing documentation and regulatory planning accompany development. Our commercial products and therapeutic candidates share scientific capabilities while following their respective regulatory requirements.
Standardized bioactive APIs
Defined chemistry.
Controlled quality.
Our botanical development programs are built around standardized multicomponent APIs with defined chemical-marker specifications. Botanical identity, analytical characterization and manufacturing controls connect the material we study with the material we develop.
SKF7®
Labisia pumila var. alata
- Gallic acid
- ≥2.0%
A standardized aqueous ethanolic extract with HPLC marker quantification and LC–MS/MS chemical profiling, supported by human clinical, proteomic, safety and pharmacokinetic evidence.
Explore SKF7® chemistryKPH1™
Kaempferia parviflora
- 5,7-Dimethoxyflavone (5,7-DMF)
- ≥8.0%
A standardized extract with 5,7-DMF quantified by HPLC. Cardiovascular and biological research is supported by a completed GLP repeated-dose toxicology and toxicokinetic study.
Explore KPH1™MKS-5®
Orthosiphon stamineus
- Rosmarinic acid
- ≥1.0%
- Sinensetin
- ≥0.05%
A standardized aqueous ethanolic extract with two defined chemical markers, supporting a preclinical program in inflammation and joint-health biology.
Explore MKS-5®Values are minimum marker specifications (NLT: not less than). These markers are quality attributes within multicomponent APIs; broader chemical profiles and study-specific biological evidence inform development.
Earlier-stage standardized APIs
Quantified chemistry.
From the earliest stage.
BR-2™, AGS-1™ and CAS-9™ follow the marker-based standardization approach used across our API portfolio. Each is characterized and quantified by HPLC against defined chemical markers.
| Program | Botanical source | Marker compound | Reported content (% w/w) |
|---|---|---|---|
| BR-2™ | Boesenbergia rotunda | Panduratin A | 5.47% |
| Pinostrobin | 13.15% | ||
| AGS-1™ | Andrographis paniculata | Andrographolide | 1.38% |
| 14-Deoxy-11,12-didehydroandrographolide | 0.55% | ||
| CAS-9™ | Centella asiatica | Madecassoside | 0.39% |
| Asiaticoside | 0.14% |
The values above are reported contents from selected development-batch analyses. They describe the analyzed batches and are distinct from minimum release specifications.
Marker-based standardization gives each program a quantified chemical profile from the earliest stage of development, providing a basis for batch-to-batch consistency, quality control and further development.
SKF7® / Chemical characterization
Botanical complexity.
A defined chemical profile.
SKF7® is a standardized water–ethanol extract of Labisia pumila var. alata, supplied as a spray-dried powder. Its development connects controlled extraction with chemical profiling, batch consistency and a defined gallic acid marker specification.
Extract
Leaves, stems and roots provide the botanical starting material. Controlled water–ethanol extraction and spray drying produce the multiconstituent powder, illustrated here inside a capsule.
Characterize
LC–MS/MS profiling investigates the chemical composition. The gallic acid structure and reported spectrum connect a defined marker to the wider multicomponent extract.
Standardize
ChromaDex reported similar chemical profiles across three studied lots. A gallic acid specification of at least 2.0%, supported by manufacturing controls, defines a key quality attribute of SKF7®.
Illustrative capsule and molecular structure. Analytical traces reproduced from the ChromaDex report, Figures 7 and 35.
Explore the 27 reported constituents
These 27 constituents were tentatively annotated by LC–MS/MS and mass-spectral database matching in the ChromaDex study. The list describes the reported analytical profile; it is not a formulation recipe or a complete inventory of the extract.
Hydroxybenzoic acids & derivatives
Gallic acid · Methyl gallate · Protocatechuic acid · Salicylic acid · Syringic acid · Vanillic acid
Hydroxycinnamic acids
m-Coumaric acid · Caffeic acid
Flavonols
Myricetin · Quercetin · Rutin
Flavanols
Catechin · Epigallocatechin
Flavanones & flavones
Naringenin · Apigenin
Saponins
Ardisiacrispin A · Ardisicrenoside A
Fatty acids
Linoleic acid · Oleic acid · Palmitic acid · Stearic acid · α-Linolenic acid
Other reported constituents
Fumaric acid · Succinic acid · Pyrogallol · Ascorbic acid · Irisresorcinol
Chemical profile: ChromaDex, Identification of SKF7™ Extract Chemical Components, report CDXA-PR-346-02, revised 20 March 2020, Table 3 and Figures 7 and 35.
SKF7® / Human proteomics
A deeper view of human metabolic biology.
Human plasma proteomics is a central part of SKF7®’s integrated evidence. SomaScan® 11K profiling of 10,788 protein targets in plasma from the Malaysia Phase II study identified coordinated changes associated with lipoprotein processing, lipid mobilization and fatty-acid oxidation.
01
Human samples
Plasma from the SKF7® Malaysia Phase II study connects the analysis to a randomized human research program.
02
Protein profiles
SomaScan® 11K measures a broad set of protein targets, creating a detailed profile for biological investigation.
03
Biological interpretation
The profiles help us investigate metabolic pathways and prioritize questions for individual-sample validation.
Conceptual research illustrations · Not to scale
Metabolic themes in the discovery analysis
Lipoprotein processing
Protein changes associated with how fats are carried and processed in circulation.
Lipid mobilization
Protein patterns linked to the mobilization of stored fat for use.
Fatty-acid oxidation
Changes associated with pathways that use fatty acids in cellular energy metabolism.
Discovery profiling used plasma pooled by study arm and visit. Individual-sample validation is needed to assess reproducibility and relationships with clinical response; causal mechanisms remain under investigation.
Explore the human datasetConnecting the platform to clinical needs.
Our standardized APIs and integrated evidence inform the questions we pursue in metabolic health and planned women’s health studies.
Medikra® AI Life Sciences
A scientific foundation.
New development possibilities.
Our planned AI-enabled operating model brings chemistry, pharmacology, safety, pharmacokinetics, clinical and molecular evidence into a framework for discovery, development and product design.
Completed target-fishing, molecular-docking, bioinformatics and pathway analyses within individual research programs provide the foundation for this next stage of analytical development.
Evidence across our programs.
Each dataset retains its biological source, analytical method and development context.
Clinical & molecular evidence
SKF7®
Randomized Phase II studies, human pharmacokinetics and plasma proteomics, alongside chemical characterization, pharmacology, safety, hepatic mRNA and microbiome research.
Explore human proteomicsCardiovascular & biological research
KPH1™
Preclinical cardiovascular and biological research supports the interpretation of activity and further development, alongside safety and exposure evidence.
Explore the KPH1™ evidenceA broader discovery portfolio
MKS-5® & earlier-stage assets
MKS-5®, BR-2, CAS-9 and AGS-1, together with documented fraction research, extend the material available for investigation according to each program’s evidence and maturity.
Explore earlier-stage researchIntended applications
Three ways to advance the science.
Discovery
Identify what to investigate next.
Connect chemical profiles with biological responses to generate mechanism and biomarker hypotheses, prioritize extracts and fractions, and explore additional indications.
Development
Inform the next clinical question.
Use clinical, exposure, safety and molecular evidence to inform dose hypotheses, endpoint selection, prospective patient stratification and study planning. Evaluate trial-design scenarios where suitable data are available.
Product design
Translate insights into new possibilities.
Investigate relationships among composition, formulation, biological activity, exposure and stability to prioritize new products, delivery approaches and potential intellectual-property opportunities.
Staged implementation
Every hypothesis returns to the science.
Scientific review and laboratory or clinical validation connect computational findings to the next development decision.
- 01
Curate the data
Consolidate datasets, document access rights and assess analytical quality.
- 02
Evaluate the methods
Select qualified tools and collaborators; assess performance against defined research questions.
- 03
Validate the findings
Test prioritized hypotheses through laboratory, biomarker or clinical research.
Shared science. Two development pathways.
Therapeutic programs.
Consumer-health innovation.
The intended model supports indication-specific therapeutic development and product-specific consumer-health innovation, with opportunities for new compositions, formulations and uses. U.S. business development is intended to connect these pathways with relevant clinical, commercial and strategic partners.
Planned source-control expansion
Consistency begins at the source.
The planned PlantBio Center is intended to strengthen botanical source control through GACP-aligned cultivation and development of GMP-ready production capacity. Beginning with Labisia pumila var. alata, the botanical source for SKF7®, it would connect verified plant material with standardized extraction and analytical characterization.
- Identity verification & DNA barcoding
- GACP-aligned cultivation partners
- Chemotypic profiling & controlled propagation
- Harvest and post-harvest validation
- Contaminant testing & traceability
Good science moves through collaboration.
Explore opportunities across characterization, translational research and clinical development.
Development pipeline
A clinical-stage lead.A growing pipeline.
SKF7® leads our botanical-drug development in abdominal obesity and related metabolic dysfunction, with a focus on central adiposity, body composition and metabolic biology. Planned clinical expansion includes women’s endocrine-metabolic health. KPH1™ and MKS-5® advance distinct preclinical programs in cardiovascular and inflammatory biology.
01 / API PROGRAMSKF7®
Research focus
Central adiposity & metabolic dysfunction
Labisia pumila
Current stagePhase II studies completedExplore program
02 / PLANNED EXPANSIONSKF7®
Research focus
Women’s endocrine-metabolic health
Labisia pumila
Current stagePlanned clinical expansionExplore expansion
03 / API PROGRAMKPH1™
Research focus
Cardiovascular function
Kaempferia parviflora
Current stagePreclinical research90-day GLP toxicology & toxicokinetics completedExplore program
04 / API PROGRAMMKS-5®
Research focus
Inflammation & joint health
Orthosiphon stamineus
Current stagePreclinical researchExplore program
Development stages & next steps
Each program advances according to its own evidence. Completed studies, preclinical research and planned clinical expansion are shown separately.
| Program / focus | Current stage | Planned next step |
|---|---|---|
| SKF7®Central adiposity & metabolic dysfunctionGallic acid ≥2.0% | Phase II studies completedTwo randomized Phase II studies and human pharmacokinetics, with human proteomics and nonclinical safety evidence. | Phase II/III protocol development and regulatory engagement |
| SKF7®Women’s endocrine-metabolic health | Planned clinical expansionPostmenopause and PMOS study concepts under review. | Develop postmenopause and PMOS study protocols with Korean investigators |
| KPH1™Cardiovascular function5,7-DMF ≥8.0% | PreclinicalCardiovascular and biological research; 90-day GLP toxicology and toxicokinetics completed, with 28-day recovery. | Phase I/II program planning |
| MKS-5®Inflammation & joint healthRosmarinic acid ≥1.0% · Sinensetin ≥0.05% | PreclinicalInflammation and joint-health efficacy research with a preclinical safety foundation. | Further efficacy and safety validation |
Clinical-stage
SKF7®
Central adiposity & metabolic dysfunction
Labisia pumila var. alata
- Standardization specification
- Gallic acid ≥2.0%
SKF7® is an oral botanical-drug candidate developed from a standardized multicomponent bioactive API. We evaluate obesity-related central adiposity and metabolic dysfunction through waist measures, body composition and metabolic biology alongside body weight.
A standardized API with an integrated development program.Analytical characterization, completed randomized human studies, human proteomics, animal and human pharmacokinetics, and nonclinical safety—including 12-month rat and 9-month dog studies—inform continued development.
Integrated evidence & development focus
- Malaysia Phase II: waist circumference, waist-to-height ratio, body weight and BMI.
- Indonesia Phase II: total body fat and the reported lean-body-mass measure.
- Human plasma proteomics: lipid processing, mobilization and fatty-acid oxidation.
- Preclinical research: adipose biology and metabolic pathways.
- Human and animal pharmacokinetics; genotoxicity; cardiovascular telemetry including QT/QTcF; and long-term rat and dog safety studies.
Our development rationale extends beyond total weight reduction. Longer controlled studies are planned to evaluate the durability and clinical significance of the findings.
Development focusPhase II/III protocol development, FDA pre-IND planning and continued product characterization, alongside the NPRA Modern Claim pathway in Malaysia and the MFDS Health Functional Food pathway in Korea.
Planned clinical expansion
SKF7®
Women’s endocrine-metabolic health
Labisia pumila var. alata
- Standardization specification
- Gallic acid ≥2.0%
Planned clinical expansion into women’s endocrine-metabolic health includes menopause-associated metabolic dysfunction and PMOS. Study concepts are under review with Korean academic investigators.
Development focusReview and refine the postmenopause and PMOS study concepts, including populations, outcomes and regulatory requirements. Menopause-related research also informs exploration of age-related metabolic and endocrine changes.
Preclinical
KPH1™
Cardiovascular function
Kaempferia parviflora
- Standardization specification
- 5,7-Dimethoxyflavone ≥8.0% · HPLC
KPH1™ is a standardized botanical API in preclinical development for cardiovascular function. Its program brings together efficacy research, biological research and a completed GLP safety and exposure study to inform clinical-development planning.
Cardiovascular efficacy research
Preclinical evaluation of cardiovascular function and tissue integrity.
Biological research
Investigation of biological responses alongside the cardiovascular findings.
Safety and exposure
A completed 90-day GLP study with a 28-day recovery period.
Development focusPhase I/II program planning informed by the integrated preclinical evidence.
Preclinical
MKS-5®
Inflammation & joint health
Orthosiphon stamineus
- Standardization specification
- Rosmarinic acid ≥1.0% · Sinensetin ≥0.05%
A standardized bioactive API program investigating inflammation and joint-health biology.
Evidence & development focus
- Preclinical safety foundation
- Preclinical efficacy research
Inflammation-linked and joint-health research.
Development focusPreclinical efficacy and safety validation in inflammatory joint disease.
Our broader API portfolio
Earlier-Stage Standardized
Botanical Programs
All Medikra® APIs are standardized botanical extracts. Our earlier-stage programs—BR-2™, AGS-1™ and CAS-9™—are standardized extracts of Boesenbergia rotunda, Andrographis paniculata and Centella asiatica, respectively. Each is characterized and quantified by HPLC against defined chemical markers, following the same marker-based approach used for SKF7®, KPH1™ and MKS-5®.
BR-2™
Boesenbergia rotunda
- Chemical markers
- Panduratin A
Pinostrobin - Development focus
- Being evaluated for an inflammatory gastrointestinal indication.
AGS-1™
Andrographis paniculata
- Chemical markers
- Andrographolide
14-Deoxy-11,12-didehydroandrographolide - Development stage
- Earlier-stage standardized API.
CAS-9™
Centella asiatica
- Chemical markers
- Madecassoside
Asiaticoside - Development stage
- Earlier-stage standardized API.
Marker-based standardization gives each program a quantified chemical profile from the earliest stage of development, providing a basis for batch-to-batch consistency, quality control and further development.
SKF7® / Wider research program
A focused clinical lead.
A broader scientific program.
Our integrated program brings together human clinical evidence, human proteomics, extensive preclinical research, and safety and pharmacokinetic studies. Wider investigations span oncology, glucose regulation, inflammation, oxidative stress and neurobiology. These are research areas at different stages of development.
Preclinical research
Oncology
A lead preclinical focus on cervical cancer, with additional breast cancer research. Cell-based, animal and molecular studies investigate biological activity and potential mechanisms.
Preclinical research
Glucose regulation
Preclinical glucose-regulation findings require clinical validation. They inform further metabolic investigation alongside the obesity-focused human program.
Preclinical & exploratory
Inflammation & oxidative stress
Laboratory and molecular research explores inflammatory signaling and oxidative-stress responses in their study-specific context.
Exploratory research
Neurobiology
Exploratory investigations inform questions for further validation, with development decisions tied to the tested material and experimental model.
Within women’s health
Age-related metabolic & endocrine changes
Menopause-related research informs this exploratory direction within women’s endocrine-metabolic health.
Research context and tested materials
The SK-UT-1 experiments used LPSE/LPSE-Liposome prototypes and retain that attribution. External Labisia research, including isolated-polysaccharide lifespan findings, provides background for investigation and does not establish SKF7® efficacy. Observed results and mechanistic interpretations are distinguished throughout development; unchanged estradiol alone does not establish a wholly non-hormonal mechanism.
Medikra® AI Life Sciences
Connecting evidence.
Informing what comes next.
Our planned AI operating model is intended to connect chemistry, clinical evidence, pharmacokinetics, safety and molecular datasets to inform future pipeline decisions.
Explore the AI strategyPrioritize candidates
Assess extracts and fractions for further investigation by bringing together chemical profiles, biological activity and computational insights.
Explore new applications
Develop hypotheses for additional indications, compositions and formulations across therapeutic and consumer-health programs.
Validate through research
Advance selected hypotheses through laboratory studies and clinical evaluation appropriate to each program.
A shared interest in better medicine.
Connect with us on development, licensing and strategic partnerships.
Human evidence & scientific record
Read the science.Understand the context.
Our SKF7® development program integrates randomized clinical studies, human pharmacokinetics, human plasma proteomics and preclinical obesity research. Together, these investigations examine central adiposity, body composition and metabolic biology—from outcomes measured in people to molecular responses and changes within tissues. KPH1™ brings together preclinical cardiovascular efficacy research, biological research, and safety and exposure assessment.
Featured research / SKF7®
Human plasma
proteomics.
10,788protein targets profiled
SomaScan® 11K
Coordinated protein changes associated with lipid processing, mobilization and fatty-acid oxidation add molecular evidence to the clinical program.
Explore the discovery researchCompleted human studies
View studiesMalaysia
Randomized Phase II
1334 months
02Indonesia
Randomized Phase II
1203 months
03India
Human pharmacokinetics
12Completed
Separate studies, reported separately. Indonesia: 120 participants.
Explore the scientific recordSKF7® / Clinical context
Why waist measures matter.
Where body fat accumulates matters alongside how much a person weighs.
Weight relative to height.
Height
Body weight
Body weight and BMI remain important measures in obesity research. However, BMI does not distinguish fat from lean tissue or describe where fat is distributed.
An indicator of central adiposity.
Waist
Waist circumference provides a practical indicator of abdominal fat accumulation, adding an important dimension to the assessment of metabolic health.
Waist size in proportion.
Height
Waist
Waist-to-height ratio relates waist circumference to a person’s height, placing abdominal size in the context of body stature.
Measurement principles · Schematic illustration · No participant data
Used alongside BMI and other clinical assessments, waist measures help identify patterns of central adiposity associated with cardiometabolic risk. This broader perspective shapes our evaluation of SKF7® across waist measures, body composition and metabolic biology.
Current clinical context and references
NICE recommends using waist-to-height ratio alongside BMI in adults with BMI below 35 kg/m² as a practical estimate of central adiposity and to help assess associated health risks. The European Association for the Study of Obesity framework also emphasizes fat distribution and health consequences in obesity assessment.
NICE NG246: identifying and assessing central adiposity · EASO framework, Nature Medicine (2024)
SKF7® / Clinical program
Three human studies.
A broader metabolic picture.
Explore each study’s design, findings and contribution to the SKF7® development program.
01 / Randomized Phase II
A clinical focus on central adiposity.
Our Malaysian multicenter, randomized, double-blind, placebo-controlled study evaluated three daily doses of SKF7®: 375 mg, 562.5 mg and 750 mg across six clinical sites.
At 750 mg/day, SKF7® demonstrated statistically significant reductions in waist circumference and waist-to-height ratio, alongside reductions in body weight and BMI, compared with placebo. Published in Diabetes, Obesity and Metabolism, these findings support our development focus on abdominal obesity and related metabolic dysfunction.
The study also provides the foundation for our human plasma proteomics program, connecting clinical outcomes with molecular investigation of lipid processing, mobilization and fatty-acid oxidation.
No deaths or treatment-related serious adverse events were reported.
Read the clinical publication133participants across the trial
4 monthsstudy duration
Adjusted estimate and 95% confidence interval
Waist circumference−2.187%p = 0.007
Waist-to-height ratio−2.294%p = 0.005
Body weight−2.915%p <0.001
BMI−2.921%p <0.001
Adjusted treatment effect (%)
Zero marks no between-group difference.
| Outcome | Adjusted change (%) | 95% confidence interval | p value |
|---|---|---|---|
| Waist circumference | −2.187 | −3.784 to −0.589 | 0.007 |
| Waist-to-height ratio | −2.294 | −3.908 to −0.681 | 0.005 |
| Body weight | −2.915 | −4.546 to −1.285 | <0.001 |
| BMI | −2.921 | −4.551 to −1.291 | <0.001 |
Multivariate-adjusted treatment-effect estimates for percentage change from baseline versus placebo. Adults with obesity (BMI ≥30 kg/m²); no standardized lifestyle or behavioral intervention. NCT05851599.
Study interpretation and regression effect sizes
The paper reported larger regression effect sizes for waist circumference (f² = 0.11) and waist-to-height ratio (f² = 0.13) than for body weight and BMI. These are model-level effect sizes, not dose-specific comparative estimates. Waist measures provide a clinical perspective on central adiposity; they do not directly quantify visceral-fat volume.
Sources: Swarna Nantha et al., Diabetes, Obesity and Metabolism (2023); February 13, 2026 F-1/A, Business, pp. 129–130.
02 / Randomized Phase II
Body composition beyond the weight measure.
Our Indonesian randomized, double-blind, placebo-controlled study evaluated SKF7® across three daily doses: 750 mg, 1,125 mg and 1,500 mg.
At 750 mg/day, SKF7® demonstrated a statistically significant reduction in total body fat and an increase in the reported lean-body-mass measure compared with placebo, despite no statistically significant difference in total body weight.
These findings explain why weight alone does not capture the full clinical picture. They support evaluating body composition alongside weight and waist measures as we advance SKF7® development.
No treatment-related serious adverse events were reported.
Read the filed clinical summary120participants across the trial
3 monthsstudy duration
Adjusted estimate and 95% confidence interval
Total body fat−4.82%p = 0.011
Reported lean-body-mass measure+2.43%p = 0.030
Body weight−0.49%p >0.05
BMI−0.69%p >0.05
Adjusted treatment effect (%)
Open markers: not statistically significant. Values describe percentage-change treatment effects, not kilogram changes.
| Outcome | Adjusted change (%) | 95% confidence interval | p value |
|---|---|---|---|
| Total body fat | −4.82 | −8.52 to −1.12 | 0.011 |
| Reported lean-body-mass measure | +2.43 | +0.22 to +4.63 | 0.030 |
| Body weight | −0.49 | −1.51 to +0.54 | >0.05 |
| BMI | −0.69 | −1.76 to +0.38 | >0.05 |
Body-composition measures and study context
Total body fat and lean body mass are the study-reported body-composition measures. The values above describe percentage-change treatment effects; they are not kilogram changes. Body-weight and BMI comparisons were not statistically significant, and no significant between-group difference in waist circumference or waist-to-height ratio was reported. Findings support further study of body composition; independence from weight change would require a specific analysis.
03 / Phase I pharmacokinetics
Measuring exposure after oral dosing.
Our randomized, placebo-controlled pharmacokinetic study evaluated a single 1,500 mg oral dose of SKF7® under fed conditions.
Blood samples collected at 22 time points over 24 hours were analyzed for gallic acid, SKF7®’s designated pharmacokinetic marker. This characterized the marker’s absorption and systemic exposure following SKF7® administration, adding measured human pharmacokinetic evidence to the development program.
Safety assessments included laboratory tests, vital signs, electrocardiograms and physical examinations. No deaths, serious adverse events or treatment-related withdrawals occurred.
12healthy adult participants
Phase Isingle-dose pharmacokinetics
-
01
Oral dosing
1,500mg
Single dose of SKF7®
Under fed conditions -
02
Blood sampling
22time points
Samples collected
Over 24 hours -
03
Marker analysis
Gallic
acidDesignated PK marker
Absorption & exposure
Human pharmacokinetics · Study design
Connecting clinical findings
with molecular evidence.
Waist measures, body composition, pharmacokinetics and human proteomics contribute distinct evidence to the SKF7® program. Together, they guide dose selection, biological investigation and the design of longer controlled studies to evaluate sustained efficacy and safety.
Explore our human proteomics research03 / SKF7® human plasma proteomics
Human findings.
Molecular evidence.
Human plasma proteomics adds molecular evidence to SKF7®’s clinical profile. Coordinated protein changes associated with lipoprotein processing, lipid mobilization and fatty-acid oxidation connect the observed clinical responses with investigation of metabolic biology.
Lipoprotein processing
Patterns associated with lipid transport and processing.
Lipid mobilization
Patterns linked to the mobilization of stored lipid.
Fatty-acid oxidation
Patterns associated with fatty-acid energy metabolism.
Conceptual grouping of themes identified in discovery profiling.
From the Phase II program.
Plasma collected at baseline and the end of the four-month Malaysia Phase II study was pooled by study arm and visit across the four arms. SomaScan® 11K profiling therefore provides a group-level discovery dataset. Individual-sample validation is needed to test reproducibility, dose relationships and associations with clinical response.
Connecting the evidence.
The coordinated changes involve lipoprotein processing, the mobilization of stored lipid and fatty-acid oxidation. Considered alongside waist and body-composition findings and preclinical research, they inform investigation of the processes underlying clinical responses and guide further validation.
How we investigate biologyDiscovery profiling used plasma pooled by study arm and visit. Individual-sample validation is needed to assess reproducibility and relationships with clinical response; causal mechanisms remain under investigation.
Company discovery research using plasma from NCT05851599. This proteomics analysis is separate from the clinical results published in Diabetes, Obesity and Metabolism (2023).
04 / SKF7® preclinical obesity research
Investigating the biology
of abdominal obesity.
Our preclinical obesity program investigates how SKF7® affects visceral adiposity, fat-tissue structure and metabolic regulation.
A 56-day study in diet-induced obese rats evaluated three oral dose levels of SKF7®, with untreated obese controls and orlistat as a reference treatment.
- Study duration
- 56 days
- Model
- Diet-induced
obesity in rats
Weight change and abdominal fat.
At the highest dose, 310 mg/kg/day, body-weight change was significantly lower than in untreated obese controls, alongside lower relative visceral adipose-tissue weight and reductions in adiposity and Lee obesity indices.
Food intake was not reduced in a sustained manner across the treatment period.
Examining changes within fat tissue.
Adipose-tissue analysis identified smaller, multilocular fat cells and qualitative UCP1 staining consistent with beige-like features at the highest dose.
These observations support further investigation of adipose-tissue remodeling and its potential contribution to the metabolic response.
Liver and endocrine observations.
The study reported histological improvement in hepatic steatosis—the accumulation of fat in the liver.
Endocrine assessments showed lower ghrelin and numerically higher terminal endogenous GLP-1 at the highest dose compared with obese controls.
Conceptual tissue illustrations · Not to scale
Connecting tissue biology
with human evidence.
These animal findings provide biological context for our clinical focus on central adiposity and body composition. Alongside human proteomic findings associated with lipid processing and fatty-acid oxidation, they guide investigation of the processes underlying SKF7®’s observed effects and help inform future clinical endpoints and biomarker studies.
Request study information · Explore the wider research program for additional research areas and tested-material attribution.
Safety & pharmacokinetics
Safety and exposure.
An integrated evidence base.
SKF7®’s development connects genotoxicity, acute and chronic toxicology, cardiovascular safety pharmacology, animal and human pharmacokinetics, and clinical safety observations. Together, these studies inform dose selection, exposure assessment and further clinical development.
- Chronic rat study
- 12 months
- Chronic dog study
- 9 months
- Randomized human studies
- 3 completed
The SKF7® safety evidence register contains 19 entries spanning nonclinical safety, pharmacokinetics, physicochemical characterization and human studies: 17 entries for SKF7® and two explicitly identified SKF7®-derivative studies.
| Research area | Program scope |
|---|---|
| Genotoxicity and mutagenicity | Bacterial reverse-mutation, chromosomal-aberration and in vitro and in vivo micronucleus assessments. The register identifies the derivative Ames study separately. |
| Acute oral toxicity | Acute-dose evaluation, including the additional GLP study completed October 9, 2026, supporting the Korean regulatory program. The earlier derivative study retains its separate test-item attribution. |
| Repeated-dose and chronic toxicity | 90-day and 12-month rat studies; a 9-month dog study with a one-month recovery period; and a dog dose-range-finding study with pharmacokinetics. |
| Cardiovascular safety pharmacology | Telemetry assessment of heart rate, blood pressure and ECG parameters, including QT/QTcF intervals. |
| Animal and human pharmacokinetics | Gallic-acid marker exposure characterized in rats, dogs and a completed randomized human pharmacokinetic study. |
| Physicochemical characterization | Water-solubility characterization by HPLC, supporting understanding of the standardized test material. |
| Human safety and tolerability | Two randomized Phase II studies in Malaysia and Indonesia, together with the randomized human pharmacokinetic study in India. |
Selected study findings and test-item context
- 90-day rat study: reported NOAEL of 2,000 mg/kg/day, the highest dose tested.
- 12-month rat study: reported overall NOAEL of 1,000 mg/kg/day. Reduced male body weight was reported at 1,500 mg/kg/day.
- 9-month dog study: NOAEL of 45 mg/kg/day. Testicular tubular findings in three males at 75 mg/kg/day were absent in recovery males; sporadic vomiting and diarrhea were reported.
- Cardiovascular telemetry: no treatment-related effects on measured heart rate, blood pressure or ECG parameters, including QT/QTcF, at single oral doses of 25, 50 or 100 mg/kg.
- Additional acute study, October 9, 2026: no mortality, treatment-related clinical signs or gross pathological findings at 2,000 mg/kg of the complete test item.
Findings are specific to the tested material, species, doses, study duration and measured endpoints. NOAEL means no-observed-adverse-effect level.
Source: SKF7® Safety Evidence Register, updated October 9, 2026. Underlying reports include VLL/0218/G/T012, VLL/0319/G/T024, VLL/0621/G/T107 and VLL/0721/G/S003.
Development priorities
Evaluate durability.
Deepen the metabolic evidence.
We are advancing a program designed to evaluate the durability and clinical significance of SKF7®’s effects on central adiposity, body composition and metabolic function.
Fixed oral dosing and the tolerability observed in completed studies inform this program. Longer controlled studies are planned to evaluate sustained efficacy and safety, with clinical outcomes and molecular findings guiding study design.
KPH1™ / Preclinical cardiovascular program
Cardiovascular research.
An integrated development program.
We bring together preclinical efficacy research, biological research and a completed GLP safety and exposure assessment to guide KPH1™’s next stage of development.
- Standardized botanical API
- Kaempferia parviflora
- Standardization specification
- 5,7-Dimethoxyflavone ≥8.0% · HPLC
01 / Cardiovascular efficacy research
Evaluating cardiovascular function.
Our preclinical efficacy program examines cardiovascular function and tissue integrity. Functional and tissue assessments inform the therapeutic rationale and the design of further studies.
02 / Biological research
Understanding biological responses.
Biological research adds context to the cardiovascular findings and guides further investigation. We evaluate this evidence alongside functional findings, safety and exposure as the program advances.
03 / Completed GLP study
Preclinical safety.
Measured systemic exposure.
The completed GLP repeated-dose study assessed safety and systemic exposure, including a recovery period.
- Study duration
- 90 days + 28-day recovery
- Highest dose tested
- 600 mg/kg/day
- Exposure assessment
- Toxicokinetics
The reported no-observed-adverse-effect level (NOAEL) was 600 mg/kg/day, the highest dose tested, under the conditions of the rat study.
Development direction
Preparing for clinical evaluation.
KPH1™ remains in preclinical development. The combined efficacy, biological, safety and exposure evidence informs Phase I/II program planning.
View KPH1™ in the pipelinePeer-reviewed & published research
The scientific record.
Explore the study designs, published findings and their context.
4 publications shown.
Clinical2023
Labisia pumila standardized extract (SKF7®) reduces percentage of waist circumference and waist-to-height ratio in individuals with obesity
Randomized Phase II clinical evaluation of SKF7® in individuals with obesity.
Translational2024
In vitro study on efficacy of SKF7®, a Malaysian medicinal plant product against SARS-CoV-2
In vitro antiviral investigation of SKF7®.
Computational2022
Marantodes pumilum: Systematic computational approach to identify their therapeutic potential and effectiveness
Computational target mapping under the taxonomic synonym Marantodes pumilum, supporting hypotheses for investigation.
Regulatory2022
Safety of an aqueous ethanolic extract of Labisia pumila as a novel food pursuant to Regulation (EU) 2015/2283
Regulatory scientific opinion assessing safety under the European Union Novel Food framework and specified conditions of use.
Let’s examine the evidence together.
For scientific discussions or study information, contact our team.
Consumer health
Products in market.Science in development.
Labeesity SKF7®, Pervira® and Starpril® contain the standardized APIs that underpin our development programs. All three are registered with Malaysia’s NPRA and marketed through clinical, pharmacy and direct-to-consumer channels.
Explore the portfolio
Labeesity SKF7®
Standardized ingredient SKF7®
API development · Phase II studies completed
Registered & marketed in Malaysia
Pervira®
Standardized ingredient KPH1™
API development · Preclinical research
Registered & marketed in Malaysia
Starpril®
Standardized ingredient MKS-5®
API development · Preclinical research
Registered & marketed in Malaysia
The commercial portfolio
01
Labeesity SKF7®
Metabolic health & weight-management support
Registered & marketed in Malaysia
Contains SKF7®, the standardized extract that anchors our clinical-stage program in obesity and metabolic dysfunction.
02
Pervira®
Energy, vitality & healthy-aging support
Registered & marketed in Malaysia
Associated with KPH1™, our preclinical standardized API program investigating cardiovascular function.
03
Starpril®
Joint-health & inflammation-linked support
Registered & marketed in Malaysia
Associated with MKS-5®, our preclinical standardized API program focused on inflammation and joint-health biology.
Markets & pathways
Commercial execution.
Therapeutic development.
Our strategy advances consumer-health commercialization and therapeutic botanical-drug development concurrently. Both draw on the same scientific and operational capabilities, with distinct development milestones and market requirements.
Malaysia
Commercially active
Our principal operating base and home market for three registered products, with further SKF7® development through the NPRA Modern Claim pathway.
United States
Development and market-entry strategy
FDA-facing botanical-drug development and consumer-health market entry, building on SKF7®’s New Dietary Ingredient notifications and U.S. patent protection.
Korea
Regulatory and clinical development
Pursuit of MFDS Health Functional Food recognition, commercial collaboration and planned studies in women’s endocrine-metabolic health.
European Union
Novel Food authorization
Labisia pumila extract authorized under Regulation (EU) 2023/972 for its specified food-supplement uses.
Build the right market partnership.
Discuss distribution, commercialization and regional market opportunities.
Our company
Rooted in Malaysia.Built for a global future.
Medikra is a clinical-stage biopharmaceutical company developing standardized bioactive APIs and botanical therapeutics. Our Malaysian scientific and commercial foundation supports an international growth strategy focused on the United States and Korea.
2006
The beginning of our Malaysian business.
Our origins
Two decades of building the scientific foundation.
Abdul Razak Mohd Isa and Mustadza Muhamad founded the Malaysian business in 2006 as Orchid Life Sdn. Bhd. It developed into Medika Natura Sdn. Bhd., now Medikra's principal operating subsidiary. That work connects research collaborations, standardized extracts, clinical studies and registered products.
Global operations
A Malaysian foundation.
An international development strategy.
Malaysia
Scientific and commercial foundation
Malaysia brings together our principal operating business, research relationships, clinical experience and registered product portfolio. Further development includes the NPRA Natural Products with Modern Claim pathway and planned expansion of botanical source-control capabilities.
United States
Therapeutic development and market entry
Our U.S. strategy focuses on FDA engagement for botanical-drug development, North American research and development coordination, and consumer-health market entry. SKF7®’s U.S. patent and New Dietary Ingredient notifications form part of this foundation.
Korea
Regulatory, clinical and commercial collaboration
Our Korean program combines pursuit of MFDS Health Functional Food recognition for SKF7® with commercial collaboration and planned studies in women’s endocrine-metabolic health. Postmenopause and PMOS study concepts are being developed with Korean academic investigators.
Leadership
Experience across science,
business and governance.
Abdul Razak Mohd Isa
Group Chief Executive Officer & Co-Founder
Co-founder of Medika Natura and Chief Executive Officer and director of Medikra since its incorporation in 2024. His experience spans company building, biotechnology policy, scientific collaboration and international development. He holds an MBA from Multimedia University, completed the UCSF QB3 Global Bio-Entrepreneurship Program and is ICH-GCP certified.
Mustadza Muhamad
Deputy Chief Executive Officer & Co-Founder
Co-founder of Medika Natura, where he serves as Deputy Chief Executive Officer, and a director of Medikra. His training includes corporate finance at the University of Cambridge and biotechnology programs at UCSF, UC Berkeley and the University of Oxford. He is ICH-GCP certified.
Datuk Ali Abdul Kadir
Chairman
Chairman of Medikra and Medika Natura. Former Chairman of the Securities Commission Malaysia and former Chairman and Partner of Ernst & Young Malaysia, with experience across capital markets, financial regulation and corporate governance.
Research history
A foundation built through collaboration.
Nearly two decades of Malaysian government-supported research, university collaboration and Ministry of Health research and clinical infrastructure underpin our programs.
Universiti Sains Malaysia
Institute for Medical Research, MOH Malaysia
Universiti Kebangsaan Malaysia
Universiti Putra Malaysia
Universiti Malaya
Forest Research Institute Malaysia
Our responsibilities
Scientific guidance. Corporate accountability.
Medikra is developing governance structures across finance, audit and risk, capital markets and scientific oversight. Its advisory-board framework supports clinical design, toxicology, product characterization, regulatory strategy and pipeline prioritization.
Botanical integrity supports product quality.
Our sourcing priorities include botanical identity, traceability, cultivation consistency, contaminant screening and biodiversity-conscious practices. The planned PlantBio Center is intended to strengthen this upstream foundation.
The next chapter is collaborative.
We welcome people and partners who share our commitment to rigorous development.
Investors & strategic partners
Clinical evidence.Commercial execution.International growth.
Medikra combines a clinical-stage lead asset, marketed products and a standardized bioactive API platform. Our growth strategy connects Malaysia’s established scientific and commercial base with therapeutic development and market-entry opportunities in the United States and Korea.
1
Clinical-stage
lead asset
2
Completed randomized
Phase II studies
3
Products marketed
in Malaysia
Our investment foundations
Scientific ambition.
Operating substance.
Clinical-stage lead asset
SKF7® advances a clinical development focus on central adiposity, body composition and metabolic dysfunction, supported by two randomized Phase II studies, human proteomics, pharmacokinetics and preclinical research.
Established commercial execution
Three registered products marketed in Malaysia provide an operating foundation for further development and international expansion.
Scientific platform, AI and intellectual property
Analytical control, granted patents and proprietary development knowledge support our standardized bioactive API platform.
Planned Medikra® AI Life Sciences integration would connect our scientific datasets to support pipeline expansion, product innovation and potential new IP across therapeutic and consumer-health development.
Explore the AI strategyInternational growth strategy
U.S. and Korean initiatives extend the platform through regulatory engagement, clinical planning, commercial partnerships and market entry.
Development objectives
Focused on the
next stage of progress.
Advancing the evidence, strengthening product consistency and building partnerships for long-term development.
- SKF7® Phase II/III protocol development and regulatory preparation.
- FDA pre-IND planning and U.S. development coordination.
- MFDS Health Functional Food recognition and Korean women’s-health study development.
- KPH1™ Phase I/II program planning.
- Develop the Medikra® AI Life Sciences operating model across discovery, development and product design.
- PlantBio source-control and production-capacity planning.
- North American consumer-health market entry.
- Corporate governance and capital-market readiness.
Intellectual property & regulatory milestones
Protecting the science.
Building market access.
Granted patents, pending applications and ingredient-use milestones support different parts of Medikra's development and commercial strategy.
2020
United States / Ingredient use
FDA NDIN 1143
New Dietary Ingredient notification for SKF7® under notified conditions of use, including a maximum intake of 300 mg per day for up to 90 days.
2022
United States / Ingredient use
FDA NDIN 1250
New Dietary Ingredient notification for SKF7® under notified conditions of use, including a maximum intake of 750 mg per day.
2022
Malaysia / Granted patent
MY-193591-A
Granted 19 October 2022: Standardised Extract of Labisia pumila for Weight Reduction and Nano-Formulation Thereof. Part of the historical IP estate.
2023
European Union / Novel Food
Regulation (EU) 2023/972
Aqueous ethanolic extract of Labisia pumila authorized for adult food supplements at a maximum of 350 mg per day, excluding pregnant and lactating women, under applicable EU conditions.
2025
United States / Granted patent
US 12,403,166 B2
Granted 2 September 2025: Labisia pumila Extract Composition and Its Pharmaceutical Formulation.
2026
Malaysia / Granted patent
MY-212429-A
Granted 20 February 2026: Labisia pumila Extract Composition and Its Pharmaceutical Formulation.
Patent applications & filing pathway
| Jurisdiction | Reference | Status | Scope |
|---|---|---|---|
| United States | US App. 19/220,442 | Pending examination | Divisional application |
| Europe | EP App. 22859531.0 | Pending examination | Composition and pharmaceutical formulation |
| South Korea | KR App. 10-2024-7018373 | Pending examination | Composition and pharmaceutical formulation |
| PCT | PCT/MY2022/000010 | Filed | International filing pathway |
Investor relations
Speak with our team.
For investor relations inquiries, contact investors@medikra.com.
A conversation grounded in the science.
Our team can discuss development priorities, scientific evidence, commercialization and strategic opportunities.
Connect with Medikra
Build the next chapter
with us.
We welcome conversations with researchers, healthcare professionals, investors, strategic partners, distributors and regulatory specialists.
Medika Natura Sdn. Bhd.
Unit 1.02, The Bousteador10, Jalan PJU 7/6, Mutiara Damansara
47800 Petaling Jaya, Selangor, Malaysia
Principal operating subsidiary of Medikra Inc.
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02
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Return to MedikraTherapeutic strategy
A broader view of metabolic health.
Effective care is built around the patient. Our development strategy examines central adiposity, body composition and metabolic biology, with the aim of expanding future treatment options.
Explore the evidenceAn integrated approach to care
AssessmentHealth, risks and priorities
Lifestyle supportNutrition and physical activity
At the centerPatient needs
and goals
and goals
Appropriate treatmentIndividualized clinical decisions
Continuing reviewResponse, safety and changing needs
The current treatment landscape
Progress in treatment.
A continuing need for individualized care.
Obesity care can combine nutritional, physical activity and behavioral support with medicines, including GLP-1 therapies, and metabolic or bariatric surgery where appropriate. Treatment choices depend on health risks, clinical suitability, patient preferences and ongoing review.1, 2
Established treatments have advanced outcomes beyond weight reduction. In SELECT, semaglutide reduced major adverse cardiovascular events in people with established cardiovascular disease and overweight or obesity, without diabetes.4
Long-term management also brings practical challenges: matching treatment to individual needs, maintaining benefit, supporting access and follow-up, and addressing accompanying health conditions. These challenges shape the questions we ask in development.1, 2
Our opportunity is to investigate additional options around defined clinical needs, with outcomes that capture fat distribution, body composition and metabolic function alongside weight.3
Clinical needs → research priorities
The questions shaping
our development program.
| Clinical need | Our research response | Next evidence |
|---|---|---|
| Central adiposity and body composition | Completed Malaysian and Indonesian randomized SKF7® studies provide distinct perspectives on waist measures, body composition and weight. | Assess durability and clinical significance in longer controlled studies. |
| Understanding metabolic responses | Human plasma proteomics and preclinical research investigate lipid processing and metabolic biology. | Validate molecular findings and their relationship to clinical responses. |
| Long-term treatment needs | Safety, pharmacokinetic and randomized clinical studies inform continued oral-drug development. | Evaluate sustained efficacy, safety and treatment experience over longer follow-up. |
Where Medikra is focused
A focused lead.
A broader pipeline.
SKF7® is our lead oral botanical-drug candidate, developed from a standardized multicomponent API. Its integrated human evidence anchors our investigation of central adiposity and metabolic dysfunction.
Human findings and molecular evidenceWomen’s endocrine-metabolic health
Separate planned SKF7® programs address menopause-associated metabolic dysfunction and PMOS. Condition-specific efficacy remains to be evaluated.
Explore women’s healthCardiovascular function
KPH1™ brings together cardiovascular efficacy research, biological research, and safety and exposure assessment to inform clinical-development planning.
Explore KPH1™The next evidence
Building the evidence
for future care.
We aim to develop useful future treatment options. A candidate’s role in care will depend on controlled clinical evidence, safety and regulatory review. Any use alongside existing therapies requires appropriate evaluation.
Further studies will assess duration of response, relevant patient populations and clinically meaningful outcomes beyond short-term changes in body measures.
Our completed findings, planned studies and exploratory research are presented separately, so the evidence can be assessed at its current stage.
Explore our development pipelineWomen’s endocrine-metabolic health
Connected biology.
Focused research.
We are planning dedicated SKF7® clinical programs in PMOS and menopause-associated metabolic dysfunction—two distinct priorities within women’s endocrine-metabolic health.
Women’s health in context
01EndocrineHormonal regulation
Whole-personhealth
03ReproductiveCycles & ovulation
04Quality of lifeFunction & well-being
The clinical need
More attention.
Deeper understanding.
Important gaps remain in the understanding, diagnosis and management of conditions affecting women. The National Academies has identified research needs across PCOS and the menopause transition, including their wider effects on health and well-being.1
Our focus is the relationship between hormonal regulation and metabolic function. We aim to develop evidence that can help define additional treatment options within comprehensive, individualized care.
SKF7® / Planned clinical expansion
Two programs.
Distinct clinical questions.
Each program is being developed around its own population, clinical needs and assessment framework.
01 / PMOSPlanned clinical development
Endocrine, metabolic
and reproductive health.
Polyendocrine metabolic ovarian syndrome (PMOS), formerly PCOS, reflects a condition extending beyond the ovaries. The new name was announced internationally in May 2026.2
Androgen
statusInsulin
sensitivityOvulatory
function
statusInsulin
sensitivityOvulatory
function
The need
Effective options address specific manifestations, including hormonal contraceptives, metformin and ovulation treatments when appropriate. No cure exists, and care must accommodate differing symptoms, metabolic needs and reproductive goals.3,4
Our planned evaluation
We intend to investigate SKF7® across insulin sensitivity, androgen status and ovulatory function. The study design and endpoints remain under review.
02 / MenopausePlanned clinical development
Metabolic health
through a life transition.
Menopause is a natural life stage. Our development focus is menopause-associated metabolic dysfunction, with particular attention to central adiposity, body composition and cardiometabolic measures.
Central
adiposityBody
compositionCardiometabolic
measures
adiposityBody
compositionCardiometabolic
measures
The need
Hormonal and nonhormonal approaches can treat menopausal symptoms. Treatment choices require individual assessment, while metabolic health warrants continuing attention alongside symptom management.5
Our planned evaluation
We intend to evaluate SKF7® for metabolic outcomes in this population. The study design and endpoints remain under review; this program does not establish SKF7® as a replacement for hormone therapy.
Program illustrations organize clinical questions; they do not depict treatment effects or a confirmed mechanism of action.
Scientific foundation
Human findings.
Molecular insight.
Our integrated SKF7® program provides the rationale for further investigation. Evidence from obesity studies does not establish benefit in PMOS or menopause-associated metabolic dysfunction.
Next steps
Evidence for
each population.
Dedicated studies are planned to evaluate clinically relevant outcomes and safety in each population. Further work will determine the magnitude, durability and clinical significance of any effects, and whether SKF7® could contribute to coordinated care.
Clinical context & references
- National Academies. Gaps and priorities in women’s health research (2024; updated 2025).
- Endocrine Society. PMOS: a new name to improve diagnosis and care (May 12, 2026).
- International Evidence-based Guideline for the Assessment and Management of PCOS (2023).
- World Health Organization. Polycystic ovary syndrome.
- NICE NG23. Menopause: identification and management.
These references provide clinical context. Medikra’s program-specific evidence is presented in Evidence; our development approach is described in Science.