Summary
Genistein has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in NAFLD / MASH (Metabolic-Associated Steatohepatitis) would be drug repurposing rather than first-in-human development. This does not mean it is approved for NAFLD / MASH (Metabolic-Associated Steatohepatitis). No registered clinical trial in this database tests Genistein specifically in NAFLD / MASH (Metabolic-Associated Steatohepatitis). The evidence below comes from published literature only, so any clinical signal has not yet been tested prospectively against this condition in a registered study. The literature layer holds 4 publications for this pair: 1 Cochrane review, 1 meta-analysis, 1 systematic review and 1 clinical trial publication. Publication years run from 2018 to 2024. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Metabolic Dysfunction-Associated Steatohepatitis ranks 292 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: MASH (formerly NASH) with fibrosis progresses to cirrhosis in ~20% over 10 years on standard care (which until 2024 was lifestyle modification only); fibrosis regression occurs spontaneously in ~25% over 5 years with sustained weight loss.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 34.0 (trials 0.0, literature 14.0, tier 15, approved bonus 5.0) |
| Registered trials | 0 total: 0 recruiting, 0 active / not yet recruiting, 0 completed, 0 other |
| Linked publications | 4 (1 Cochrane review, 1 meta-analysis, 1 systematic review, 1 clinical trial publication) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | AGTR1 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
No registered trial links Genistein to NAFLD / MASH (Metabolic-Associated Steatohepatitis) in the current OSMF trial extract.
Published literature
- Meta-analysis Therapeutic potential of traditional Chinese medicine in the prevention and treatment of digestive inflammatory cancer transformation: Portulaca oleracea L. as a promising drugShao G, Liu Y, Lu L et al. · Journal of ethnopharmacology · 2024 · PMID 38447616
- Systematic review Polyphenol Intervention Ameliorates Non-Alcoholic Fatty Liver Disease: An Updated Comprehensive Systematic ReviewRanneh Y, Bedir AS, Abu-Elsaoud AM et al. · Nutrients · 2024 · PMID 39683546
- Cochrane review Efficacy and safety of dietary polyphenol supplementation in the treatment of non-alcoholic fatty liver disease: A systematic review and meta-analysisYang K, Chen J, Zhang T et al. · Frontiers in immunology · 2022 · PMID 36159792
- Clinical trial publication Genistein supplementation improves insulin resistance and inflammatory state in non-alcoholic fatty liver patients: A randomized, controlled trialAmanat S, Eftekhari MH, Fararouei M et al. · Clinical nutrition (Edinburgh, Scotland) · 2018 · PMID 28647291
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target AGTR1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Genistein approved for NAFLD / MASH (Metabolic-Associated Steatohepatitis)?
Genistein has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in NAFLD / MASH (Metabolic-Associated Steatohepatitis) would be drug repurposing rather than first-in-human development. This does not mean it is approved for NAFLD / MASH (Metabolic-Associated Steatohepatitis). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Genistein in clinical trials for NAFLD / MASH (Metabolic-Associated Steatohepatitis)?
No registered clinical trial in this database tests Genistein specifically in NAFLD / MASH (Metabolic-Associated Steatohepatitis). The evidence below comes from published literature only, so any clinical signal has not yet been tested prospectively against this condition in a registered study.
What does the evidence show for Genistein in NAFLD / MASH (Metabolic-Associated Steatohepatitis)?
Synthesis-level literature links Genistein to NAFLD / MASH (Metabolic-Associated Steatohepatitis), but no registered trial in this database tests the pair, so the evidence is observational, pooled from other indications, or pre-dates registry practice. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target AGTR1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.