Summary
Valsartan 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 Valsartan 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: 4 clinical trial publications. Publication years run from 2015 to 2025. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
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 | 28.0 (trials 0.0, literature 8.0, tier 15, approved bonus 5.0) |
| Registered trials | 0 total: 0 recruiting, 0 active / not yet recruiting, 0 completed, 0 other |
| Linked publications | 4 (4 clinical trial publications) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | inhibitor; inhibitor |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 Valsartan to NAFLD / MASH (Metabolic-Associated Steatohepatitis) in the current OSMF trial extract.
Published literature
- Clinical trial publication Effects of a polypill on circulating levels of resistin and visfatin in men with non-alcoholic fatty liver disease: A five-year clinical trialNazari-Robati M, Dehesh T, Shahouzehi B et al. · PloS one · 2025 · PMID 41060939
- Clinical trial publication Polypill protects MAFLD patients from cardiovascular events and mortality: a prospective trialRamandi A, George J, Merat S et al. · Hepatology international · 2023 · PMID 37227560
- Clinical trial publication Polypill for prevention of cardiovascular diseases with focus on non-alcoholic steatohepatitis: the PolyIran-Liver trialMerat S, Jafari E, Radmard AR et al. · European heart journal · 2022 · PMID 35048107
- Clinical trial publication PolyPill for Prevention of Cardiovascular Disease in an Urban Iranian Population with Special Focus on Nonalcoholic Steatohepatitis: A Pragmatic Randomized Controlled Trial within a Cohort (PolyIran - Liver) - Study ProtocolMerat S, Poustchi H, Hemming K et al. · Archives of Iranian medicine · 2015 · PMID 26265520
Mechanism and notes
Recorded mechanism or class: inhibitor; inhibitor.
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 Valsartan approved for NAFLD / MASH (Metabolic-Associated Steatohepatitis)?
Valsartan 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 Valsartan in clinical trials for NAFLD / MASH (Metabolic-Associated Steatohepatitis)?
No registered clinical trial in this database tests Valsartan 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 Valsartan in NAFLD / MASH (Metabolic-Associated Steatohepatitis)?
The record for Valsartan in NAFLD / MASH (Metabolic-Associated Steatohepatitis) rests on 4 publications without a registered trial. This is a lead for hypothesis generation, not evidence of efficacy. 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.