Pemvidutide

What it is

Pemvidutide is the defined GLP-1/glucagon candidate also called MD1373, MD-1373, SP1373, SP-1373, and ALT-801. FDA maps it to UNII A35F525WBG. Other dual or triple incretin drugs are not aliases just because their receptor lists overlap.

Findings apply to the protocol-controlled investigational injectable product, exposure, population, and outcome. They do not authenticate an outside product or transfer to another sequence, receptor candidate, formulation, route, or combination.

Why people care

Interest centers on MASH, liver fat, weight, and a combined GLP-1/glucagon mechanism. The evidence requires strict separation of investigational signals from approval, surrogate or histologic outcomes from clinical benefit, and trial-product identity from outside products.

What humans actually show

Pemvidutide is investigational. Phase 2 human studies report signals for MASH resolution, liver fat, biomarkers, and weight in specified populations, but they do not establish an approved indication, long-term clinical benefit, or a complete safety profile; Breakthrough Therapy designation is not approval.

• randomized human — 212 adults with biopsy-confirmed MASH and stage F2 or F3 fibrosis; Route: Subcutaneous investigational trial product; Outcome: MASH resolution without fibrosis worsening and fibrosis improvement without MASH worsening at week 24: MASH resolution without fibrosis worsening was reported in 20% assigned placebo, 58% in one pemvidutide group, and 52% in the other. Fibrosis improvement without MASH worsening was 28%, 33%, and 36%, with pemvidutide-versus-placebo differences not statistically significant. The seam: Phase 2b and 24-week primary time point; Histologic surrogate outcomes rather than clinical events; Fibrosis endpoint did not show a statistically significant treatment difference; Sponsor-funded trial; No approved label or postmarketing record.
• randomized human — 94 adults with metabolic dysfunction-associated steatotic liver disease; Route: Subcutaneous investigational trial product; Outcome: Relative liver fat, biomarkers, weight, and adverse events over 12 weeks: Mean relative liver-fat reductions were 46.6%, 68.5%, and 57.1% in three pemvidutide groups and 4.4% with placebo. The greatest reported mean weight change was -4.3%; the abstract reported no severe or serious adverse events. The seam: Small sample and 12-week assessment; Liver fat and biomarkers are surrogate outcomes; Cannot characterize uncommon or delayed risks; Sponsor-funded trial; Does not establish an approved MASH or obesity indication.
• randomized human — 391 adults with overweight or obesity in the MOMENTUM study; Route: Subcutaneous investigational trial product; Outcome: Body-weight change and adverse events over 48 weeks: A conference abstract reported mean weight changes of -10.3%, -11.2%, and -15.6% in three pemvidutide groups versus -2.2% with placebo; most adverse events were described as mild or moderate, with one drug-related serious adverse event. The seam: Conference abstract rather than full peer-reviewed outcomes paper; Limited methods and safety detail in the accessible record; Sponsor-employee authorship; Weight change does not establish approval; Long-term clinical outcomes remain unknown.

Mechanistic and nonhuman evidence

• mechanistic — FDA substance identity and investigational human-study rationale; Route: Substance record and subcutaneous investigational exposures; Outcome: Combined GLP-1 and glucagon receptor activity: The substance record establishes the candidate identity, while trial publications describe combined GLP-1 and glucagon receptor activity as the intended mechanism. The seam: Mechanistic plausibility does not establish clinical benefit; Does not establish comparative efficacy; Does not establish long-term safety; Does not authenticate another product.

FDA and U.S. status

An exact Drugs@FDA substance-name search returned no pemvidutide application, and pemvidutide was not listed on FDA's 2026 novel-drug approvals page in this dated search. The sponsor reports FDA Breakthrough Therapy designation for MASH and planned phase 3 work; designation, planning, and phase 2 evidence are not marketing approval.

Risks and warning limits

• human trial: IMPACT reported adverse events in 78% and 81% of the pemvidutide groups and 67% with placebo; discontinuation due to adverse events occurred in 0% and 1% of the pemvidutide groups and 2% with placebo. Most events were described as mild or moderate.
• human trial: The 12-week MASLD abstract reported no severe or serious adverse events, but the sample and duration cannot rule out uncommon or delayed risks.
• human trial: The MOMENTUM conference abstract described most adverse events as mild or moderate and reported one drug-related serious adverse event.
• not characterized: No FDA-approved pemvidutide label exists in the reviewed records, so a complete labeled contraindication, warning, pregnancy, interaction, and postmarketing profile is not characterized.

What remains unknown

• Whether the planned phase 3 MASH program will begin, complete, reproduce phase 2 findings, or demonstrate clinical benefit remains unknown.
• RECLAIM (NCT06987513), a 100-participant phase 2 alcohol-use-disorder study, was listed as completed on July 30, 2026, with no posted results in this review. RESTORE (NCT07009860), a phase 2 alcohol-associated-liver-disease study, was active, not recruiting, with no posted results. Registry status does not establish an outcome.
• A full peer-reviewed outcomes paper for the 48-week MOMENTUM study was not identified in the dated PubMed title search.
• Long-term cardiovascular, hepatic, gallbladder, pancreatic, renal, gastrointestinal, endocrine, reproductive, and immunogenicity outcomes remain insufficiently characterized.
• Results of the completed registered drug-interaction study were not posted in the reviewed ClinicalTrials.gov record.
• The identity and quality of any product outside a registered trial cannot be inferred from the pemvidutide or ALT-801 name.

Product identity and quality limits

• FDA's UNII record establishes a substance identity and does not approve a drug product.
• Breakthrough Therapy designation concerns development and review of an investigational candidate; the sponsor itself describes pemvidutide as investigational.
• Trial results apply to protocol-controlled study products and cannot authenticate an outside product carrying the pemvidutide or ALT-801 name.
• Shared GLP-1 or glucagon receptor language cannot establish sequence, concentration, purity, sterility, stability, route, handling, or equivalence.

What has been studied together

• Metformin, atorvastatin, warfarin, digoxin, and combined oral contraceptive — coadministration studied: NCT04972396 registered coadministration in a completed phase 1 drug-interaction study, but the reviewed record did not post results. Registration alone does not establish absence of interaction, safety, or clinical benefit.
• Other GLP-1 receptor agonists or metabolic candidates — no direct evidence: The focused PubMed and ClinicalTrials.gov pass did not identify controlled human outcome evidence supporting combination with another GLP-1 receptor agonist, glucagon-receptor candidate, semaglutide, tirzepatide, or an online metabolic stack. Missing evidence does not establish safety.

What people are hearing

These are claims this profile checks, not established conclusions.

• Claim under review: “FDA Breakthrough Therapy designation means pemvidutide is FDA approved.”
• Claim under review: “Phase 2 MASH and liver-fat results prove long-term clinical benefit.”
• Claim under review: “A registered drug-interaction study proves the listed combinations are safe.”

Questions readers raise

• No reproducible community sample was collected for this profile.

The community-signal layer is not efficacy or safety evidence. Its current limits are:

• No reproducible community sample has been collected for this profile.
• Self-reports would be subject to selection and reporting bias.
• The product, sequence, formulation, route, exposure, and concurrent medicines in a self-report could not be verified.
• Diet, activity, underlying disease, and other medicines could confound an anecdote.
• Reported weight, liver, metabolic, and adverse outcomes could not be independently verified.
• Anecdotes cannot establish efficacy, safety, approval, product identity, or interaction compatibility.

What would change this answer

• A future FDA approval, complete review action, or approved label would change the investigational status and warning boundary.
• Completed, peer-reviewed phase 3 trials measuring histologic and clinical outcomes with adequate follow-up could change the efficacy and safety boundary.
• Posted drug-interaction results could change the current inability to characterize the registered coadministrations.
• Finished-product analytical and regulatory records could change the inability to transfer study-product identity to another product.

Sources and records

• WADA — 2026 Prohibited List

• FDA UNII search record for pemvidutide — U.S. Food and Drug Administration
• Drugs@FDA exact-substance API search for pemvidutide — U.S. Food and Drug Administration
• FDA novel-drug approvals for 2026 — U.S. Food and Drug Administration
• Altimmune announces FDA Breakthrough Therapy designation for pemvidutide in MASH — Altimmune
• Altimmune first-quarter 2026 update describing planned phase 3 work — Altimmune
• Safety and efficacy of weekly pemvidutide versus placebo for metabolic dysfunction-associated steatohepatitis (IMPACT): 24-week results from a multicentre, randomised, double-blind, phase 2b study — The Lancet / PubMed
• Pemvidutide in subjects with non-alcoholic fatty liver disease: a randomized phase 2 trial — Journal of Hepatology / PubMed
• MOMENTUM conference abstract: pemvidutide in overweight or obesity — Diabetes
• NCT05989711: IMPACT — ClinicalTrials.gov
• NCT06987513: RECLAIM — ClinicalTrials.gov
• NCT07009860: RESTORE — ClinicalTrials.gov
• NCT04972396: pemvidutide drug-interaction study — ClinicalTrials.gov
• ClinicalTrials.gov intervention search for pemvidutide — U.S. National Library of Medicine
• PubMed title search for pemvidutide — U.S. National Library of Medicine