Home / Drugs & Interventions / Brenipatide / History Brenipatide History and Updates 21 events · 2025 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: June 18, 2026 .
Brenipatide — history and updates FDA approvals, label revisions, recalls, trials, and pivotal publications FDA approvals Label revisions Recalls + safety Trials Publications 2026 2027 2028 Trial: NCT07476118
2026-03-18 → 2027-02-28 (primary completion) Trial: NCT07420283
2026-02-13 → 2028-03-31 (primary completion) Trial: NCT07410507
2026-02-10 → 2027-11-30 (primary completion) Trial: NCT07412756
2026-02-09 → 2028-02-29 (primary completion) Trial: NCT07286175
2025-11-24 → 2027-11-30 (primary completion) Trial: NCT07223840
2025-11-03 → 2027-02-28 (primary completion) Trial: NCT07219173
2025-10-22 → 2028-04-30 (primary completion) today (2026-06-15) FDA approval Label revision Recall or safety Trial activity Pivotal publication
Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-15 Download chart as PNG
This page tracks every FDA action, clinical trial milestone, and major publication for Brenipatide since 2025, drawn from openFDA, ClinicalTrials.gov, and PubMed.
Upcoming & expected milestones Primary completion Feb 28, 2027 · ClinicalTrials.gov
A Study of Brenipatide (LY3537031) in Healthy Participants With Overweight or Obesity
Primary completion Feb 28, 2027 · ClinicalTrials.gov
A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse
Primary completion Nov 30, 2027 · ClinicalTrials.gov
A Study of Brenipatide in Adult Participants With Schizophrenia
Primary completion Nov 30, 2027 · ClinicalTrials.gov
A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)
Primary completion Feb 29, 2028 · ClinicalTrials.gov
A Study of Brenipatide in Adult Participants With Major Depressive Disorder
Primary completion Mar 31, 2028 · ClinicalTrials.gov
A Study of Brenipatide in Participants With Opioid Use Disorder
Primary completion Apr 30, 2028 · ClinicalTrials.gov
A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
Past events 2026
Trial started Mar 18, 2026 · ClinicalTrials.gov
A Study of Brenipatide (LY3537031) in Healthy Participants With Overweight or Obesity
Trial registered Mar 17, 2026 · ClinicalTrials.gov
A Study of Brenipatide (LY3537031) in Healthy Participants With Overweight or Obesity
Trial registered Feb 19, 2026 · ClinicalTrials.gov
A Study of Brenipatide in Participants With Opioid Use Disorder
Trial registered Feb 17, 2026 · ClinicalTrials.gov
A Study of Brenipatide in Adult Participants With Major Depressive Disorder
Trial registered Feb 13, 2026 · ClinicalTrials.gov
A Study of Brenipatide in Adult Participants With Schizophrenia
Trial started Feb 13, 2026 · ClinicalTrials.gov
A Study of Brenipatide in Participants With Opioid Use Disorder
Trial started Feb 10, 2026 · ClinicalTrials.gov
A Study of Brenipatide in Adult Participants With Schizophrenia
Trial started Feb 9, 2026 · ClinicalTrials.gov
A Study of Brenipatide in Adult Participants With Major Depressive Disorder
2025
Trial registered Dec 16, 2025 · ClinicalTrials.gov
A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)
Trial started Nov 24, 2025 · ClinicalTrials.gov
A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)
Trial registered Nov 3, 2025 · ClinicalTrials.gov
A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse
Trial started Nov 3, 2025 · ClinicalTrials.gov
A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse
Trial started Oct 22, 2025 · ClinicalTrials.gov
A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
Trial registered Oct 21, 2025 · ClinicalTrials.gov
A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
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.