Pemvidutide
Also called ALT-801.
Pemvidutide is still investigational, with no FDA-approved product. This page cites 2 sources, and the strongest evidence comes from human trials.
- Status
- Investigational
- Form
- Injection
- Half-life
- Not modeled
- Strongest evidence
- Human trials
- Cited claims
- 2
- Last updated
- November 6, 2026
What the evidence says
Each claim names the kind of study behind it, what it can't tell you, and where it comes from.
Human trials
In IMPACT, 212 adults with biopsy-confirmed MASH and F2 or F3 fibrosis were randomized. At 24 weeks, MASH resolution without fibrosis worsening occurred in 58% and 52% of pemvidutide groups versus 20% with placebo.
Limits: The separate primary endpoint of fibrosis improvement without worsening MASH was not significant. This phase 2b biopsy result does not establish fewer liver-related complications or long-term benefit in cirrhosis, and it does not provide FDA approval.
Human trials
Altimmune reported that continued treatment in IMPACT improved non-invasive liver fibrosis measures at 48 weeks compared with placebo, with further changes after the 24-week assessment.
Limits: These are sponsor-reported results from the same trial, not an independent replication. Non-invasive measures differ from biopsy-proven fibrosis improvement and cannot establish reduced cirrhosis, liver failure, or mortality.
Regulatory status
United States
Pemvidutide remains investigational and has no FDA-approved product as of November 6, 2026. Altimmune reports that its PERFORMA phase 3 MASH trial began in 2026. FDA Fast Track and Breakthrough Therapy designations support development but do not grant marketing approval.