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
Clinical-stage biopharmaceutical science
Where nature
meets next-gen
medicine™
Medikra® is a revenue-generating, 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
120per protocol
3 months
India
Human pharmacokinetics
12participants
Completed
Separate studies, reported separately.
10,788
Safety & 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.
KPH1™
A completed GLP repeated-dose toxicology and toxicokinetic study strengthens the cardiovascular program’s preclinical evidence and informs 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-enabled operating model is designed to connect chemistry, human evidence and molecular research across discovery, development and product design.
Built on the scientific programs behind SKF7®, KPH1™ and our wider portfolio, the model aims to turn accumulated evidence into new research directions, product opportunities and potential intellectual property.
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 profiles with biological pathways and human evidence to explore mechanisms, identify biomarker hypotheses and prioritize extracts, fractions and potential indications for validation.
Development
Bring clinical response, pharmacokinetics, molecular findings and safety data together to inform dose and exposure hypotheses, endpoint selection, patient stratification and clinical-study planning.
Product design
Explore compositions, formulations, delivery approaches and new applications of standardized bioactive APIs, with the potential to support differentiated products and new intellectual property.
International growth
Three markets.
One integrated strategy.
Our international strategy connects Malaysia’s scientific and commercial foundation, a dedicated U.S.-based company, and Korean regulatory, clinical and commercial partnerships. Across these markets, we advance botanical therapeutics and consumer-health products built on the same standardized bioactive APIs.
Malaysia
Our scientific and operating foundation.
Malaysia is home to Medika Natura, our principal operating business, and the research relationships underpinning our development programs. Human clinical research, standardized API development and three registered, marketed products—Labeesity SKF7®, Pervira® and Starpril®—provide an established foundation. Further SKF7® development includes the NPRA Natural Products with Modern Claim pathway and expansion of botanical source-control capabilities.
United States
A dedicated company. A coordinated growth strategy.
Medikra U.S., our U.S.-based company, provides a dedicated platform for North American development and commercialization. Its mandate brings together FDA-facing botanical-drug development and consumer-health market entry, with priorities spanning pre-IND preparation, clinical-development coordination, strategic partnerships and commercial execution.
SKF7®’s U.S. patent protection, New Dietary Ingredient notifications and completed human studies support this strategy, connecting our existing scientific platform with the next stages of therapeutic development and North American growth.
Korea
Regulatory development. Planned clinical expansion. Commercial reach.
Our partnership with NS Shopping Co., Ltd. (NS Home Shopping), part of Harim Group, connects Medikra’s scientific platform with Korean regulatory, product-development and commercial capabilities.
Priorities include pursuing MFDS Health Functional Food recognition for SKF7® in body-fat reduction and developing two planned studies in women’s endocrine-metabolic health—postmenopause and PMOS—with investigators at Soonchunhyang University hospitals. Together, these activities support new clinical applications and future consumer-health opportunities in Korea.
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 aging & ischemic-stress biology | 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 molecular 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 datasetMedikra® 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 & molecular research
KPH1™
Cardiovascular pharmacology supported by bulk mRNA, microRNA and single-nucleus RNA sequencing, connecting functional research with investigation of biological mechanisms.
Explore the programA 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 aging & ischemic-stress biology
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 aging & ischemic-stress biology5,7-DMF ≥8.0% | PreclinicalCardiovascular and molecular 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 aging & ischemic-stress biology
Kaempferia parviflora
- Standardization specification
- 5,7-Dimethoxyflavone ≥8.0% · HPLC
KPH1™ combines cardiovascular efficacy research and molecular profiling with completed GLP repeated-dose toxicology and toxicokinetics, supporting further clinical-development planning.
Completed GLP safety and exposure study.A 90-day repeated-dose toxicology and toxicokinetic study in Wistar rats, with 28-day recovery, supports further clinical-development planning alongside cardiovascular efficacy and molecular research.
Evidence & development focus
- Preclinical cardioprotection research
- Completed 90-day GLP repeated-dose toxicology and toxicokinetics with 28-day recovery
- Bulk mRNA, microRNA and single-nucleus RNA sequencing
- Translational bioinformatics
Vascular stress, oxidative injury and cellular energy biology.
Development focusPhase I/II program planning supported by the preclinical efficacy and safety 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.
SKF7®’s development focus brings central adiposity, body composition and metabolic biology into one integrated evidence narrative. Explore the Malaysia and Indonesia Phase II findings, human proteomics and preclinical research, supported by pharmacokinetics and safety studies.
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: 150 randomized; 120 per-protocol completers.
Explore the scientific recordSKF7® / Clinical program
Two Phase II perspectives.
A broader metabolic picture.
The completed randomized studies evaluate different aspects of SKF7®’s clinical profile. Their findings support investigation across waist measures, body composition and metabolic function alongside total body weight.
01 / Randomized Phase II
Central adiposity and anthropometric outcomes.
A randomized, double-blind, placebo-controlled, dose-ranging study in 133 participants evaluated SKF7® across six Malaysian clinical sites over four months. At 750 mg/day, SKF7® demonstrated statistically significant reductions in waist circumference, waist-to-height ratio, body weight and BMI versus placebo.
Read the clinical publication133participants across the trial
4 monthsstudy duration
| 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); daily doses of 375, 562.5 and 750 mg or placebo; 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.
At 750 mg/day over 12 weeks, the Indonesian study reported a significant reduction in total body fat and an increase in the reported lean-body-mass measure versus placebo, despite no statistically significant difference in total body weight. These findings explain why weight alone does not capture the full clinical picture.
Read the filed clinical summary120per-protocol completers
150 participants randomized
150 participants randomized
12 weeksreported efficacy assessment
| 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 |
Adjusted treatment-effect estimates for percentage change from baseline versus placebo, as reported in the February filing. Randomized, double-blind, placebo-controlled, dose-ranging study; daily doses of 750, 1,125 and 1,500 mg or placebo; no structured diet or exercise intervention. NCT04557267.
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.
Source: February 13, 2026 F-1/A, Business, pp. 127–128. Results are presented separately from the Malaysian study because design, participants and duration differ.
Human pharmacokinetics
Characterizing human exposure.
A completed Phase I pharmacokinetic study in India characterized human exposure following oral administration of SKF7®, using gallic acid as a bioanalytical marker. This exposure evidence forms part of the integrated clinical-development program.
12participants across the trial
Phase Istudy phase
03 / 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 evidence
Investigating the biology
behind the clinical questions.
Preclinical research connects adipose-tissue findings with investigation of metabolic pathways. Animal and laboratory studies inform the rationale and priorities for further human evaluation.
Central fat and tissue remodeling.
Diet-induced obesity studies reported reductions in visceral fat and histological features of beige-like adipose remodeling.
From observed effects to testable mechanisms.
Metabolic, inflammatory and molecular findings inform hypotheses for targeted validation. Their connection to human clinical response remains an active research question.
A foundation for continued development.
Animal and human pharmacokinetics and the extensive safety program support interpretation of exposure and planning of further studies.
An integrated development rationale.
Malaysia’s waist-based findings, Indonesia’s body-composition results, human plasma proteomics and preclinical biology together support evaluating SKF7® across central adiposity, body composition and metabolic function. Each retains its own study design, tested material and development context.
Preclinical development context: February 13, 2026 F-1/A, Business. See the wider research program for 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.
KPH1™ / Completed preclinical study
GLP toxicology.
Measured systemic exposure.
KPH1™ combines cardiovascular efficacy research and molecular profiling with a completed GLP repeated-dose toxicology and toxicokinetic study, supporting further clinical-development planning.
- Model and duration
- Wistar rats
90 days + 28-day recovery - Dose levels
- 150, 300 and 600
mg/kg/day - Toxicokinetic marker
- 5,7-Dimethoxyflavone
LC–MS/MS analysis
Study finding and development context
The reported NOAEL was 600 mg/kg/day, the highest dose tested, under the conditions of the Wistar-rat study. The completed preclinical safety and exposure assessment informs further development alongside the cardiovascular and molecular research program.
Source: signed final report VLL/0125/G/T018, completed June 1, 2026; repeated-dose oral toxicity and toxicokinetics of KPH1™ with recovery in Wistar rats.
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.
Competitive context
Within an obesity-treatment landscape that includes GLP-1–based therapies, SKF7®’s development priorities center on oral dosing, central adiposity, body composition and metabolic biology. Comparative tolerability, long-term adherence, maintenance and combination use require dedicated studies. The completed SKF7® studies do not establish comparative efficacy or safety against GLP-1 therapies.
Peer-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 aging and mitochondrial biology.
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 revenue-generating, 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, revenue-generating 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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Website content does not replace advice, diagnosis or treatment from a qualified healthcare professional. Decisions about an individual’s health or treatment should be discussed with an appropriate healthcare professional.
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Research findings should be read in the context of the studies described, including their design, population, formulation, dose, duration and endpoints. Clinical observations, laboratory findings and proposed mechanisms address different scientific questions and should be interpreted accordingly. Results from one study do not guarantee the same outcomes in another population or setting.
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