Primary completion· ClinicalTrials.gov
RESTORE TRIAL: A Phase 2 Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)
Pemvidutide History and Updates
13 events · 2021 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: .
0
FDA Approvals
0
Label Revisions
13
Trial Milestones
0
Pivotal Publications
Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-05-19Download chart as PNG
This page tracks every FDA action, clinical trial milestone, and major publication for Pemvidutide since 2021, drawn from openFDA, ClinicalTrials.gov, and PubMed.
Upcoming & expected milestones
Past events
2026
Primary completion· ClinicalTrials.gov
RECLAIM STUDY: A Phase 2 Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol Use Disorder (AUD) in Subjects With O
2025
Primary completion· ClinicalTrials.gov
IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH)
Trial started· ClinicalTrials.gov
RESTORE TRIAL: A Phase 2 Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)
Trial registered· ClinicalTrials.gov
RESTORE TRIAL: A Phase 2 Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)
Trial registered· ClinicalTrials.gov
RECLAIM STUDY: A Phase 2 Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol Use Disorder (AUD) in Subjects With O
Trial started· ClinicalTrials.gov
RECLAIM STUDY: A Phase 2 Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol Use Disorder (AUD) in Subjects With O
Primary completion· ClinicalTrials.gov
IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH)
2023
Trial registered· ClinicalTrials.gov
IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH)
Trial started· ClinicalTrials.gov
IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH)
2022
Primary completion· ClinicalTrials.gov
Pemvidutide (ALT-801) DDI Study in Healthy Volunteers
2021
Trial started· ClinicalTrials.gov
Pemvidutide (ALT-801) DDI Study in Healthy Volunteers
Trial registered· ClinicalTrials.gov
Pemvidutide (ALT-801) DDI Study in Healthy Volunteers
Sources
FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.