Digestive & weight GLP-1 / glucagon dual agonist
Pemvidutide
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- Not FDA-approved for any use
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
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Key takeaway
Pemvidutide is an investigational GLP-1 and glucagon dual-receptor agonist, developed by Altimmune as a once-weekly injection for liver disease (MASH) and obesity. In Phase 2 trials it reduced liver fat and body weight, and a Phase 3 program in MASH is being planned. As of 2026 it is not approved anywhere.
At a glance
- FDA status
- Investigational peptide, not approved by the FDA or any regulator
- What it is
- GLP-1 and glucagon receptor dual agonist given as a once-weekly injection
- Research
- Human evidence from Phase 2 trials in MASH, fatty liver, and obesity
- Development
- A Phase 3 MASH program is being planned
- Evidence strength
- Moderate research
Summary
Pemvidutide is an investigational GLP-1 and glucagon dual agonist studied for MASH and obesity. Learn how it works and what Phase 2 trials have found so far.
What is pemvidutide?
Pemvidutide is an experimental dual-receptor agonist that activates the GLP-1 and glucagon receptors, developed by Altimmune under the code ALT-801. It is given as a once-weekly injection and is being developed primarily for metabolic dysfunction-associated steatohepatitis (MASH), a form of fatty liver disease, as well as for obesity. It is investigational and not approved.
How does it work?
Pemvidutide combines two hormone actions. The GLP-1 arm reduces appetite and supports weight loss, while the glucagon arm acts directly on the liver to stimulate fat burning and reduce fat production. The rationale for pairing them is to combine weight loss with a direct effect on liver fat, which is relevant to MASH. This describes the proposed mechanism, separate from patient outcomes.
Is it FDA-approved?
Safety note
Status: Investigational peptide, not approved by the FDA or any regulator
Category: In clinical trials · Primary body area: Digestive & weight
No. Pemvidutide is investigational and not approved. According to Altimmune, the lead focus is MASH, with a Phase 3 program being planned following positive Phase 2b results, and an obesity Phase 2 program has also been completed.
What does the research show?
Editor’s note
Evidence strength: Moderate research (3 human · 0 animal/cell studies)
It has consistent, positive Phase 2 human evidence in liver disease and obesity, but no completed Phase 3.
The evidence is from Phase 2 studies, two of them indexed on PubMed:
| Trial | Population | Result |
|---|---|---|
| Phase 2b IMPACT trial | Biopsy-confirmed MASH | Positive results on liver endpoints at 24 weeks of an ongoing trial |
| Phase 1b/2a study | Fatty liver | Large relative reductions in liver fat along with weight loss over 24 weeks |
| Phase 2 obesity trial, reported by the company (not yet peer-reviewed) | Obesity | Meaningful weight loss at the top dose |
These are positive Phase 2 findings; no Phase 3 trial has been completed, so efficacy is not yet established at the confirmatory level.
Sources: the Phase 2b IMPACT trial (Noureddin et al., The Lancet, 2025, DOI: 10.1016/S0140-6736(25)02114-2) and a Phase 1b/2a fatty-liver study (Browne et al., JHEP Reports, 2025, DOI: 10.1016/j.jhepr.2025.101483), both indexed on PubMed; and Altimmune development updates. This document is educational, is not medical advice or a health claim, and is not an offer to sell any product.
Registered human trials
3 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
- [3]
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