Brenipatide for Tobacco use disorder

Phase 2ActiveEli Lilly and Company (LLY)

Indications for Brenipatide: Alcohol use disorder · Phase 3 Tobacco use disorder · Phase 2 Opioid use disorder · Phase 2 Schizophrenia · Phase 2 Bipolar disorder · Phase 2 Major depressive disorder · Phase 3

Phase 2 relapse-prevention trial (RENEW-Smk-1, n~222) of brenipatide in adults who have quit smoking cigarettes; primary endpoint CO-confirmed continuous abstinence with allowed slips.

Data current as of 1 Feb 2027

Development timeline

Phase 2Oct 2025 – Feb 2027

Feb 2027
Upcoming↗
Sept 2026
Conference presentationConference Presentation↗
Aug 2026
Trial startedTrial Started
Feb 2026
Trial startedTrial Started
Feb 2026
Trial startedTrial Started
Feb 2026
Trial startedTrial Started
Nov 2025
Trial startedTrial Started
Nov 2025
Programme became clinically active with first patient-trial start in this indication; all trials recruiting as of Oct 2026.
Nov 2025
Trial startedTrial Started
Oct 2025
Trial startedTrial Started
Oct 2025
Trial startedTrial Started

Readouts

Primary completion Feb 2027 (RENEW-Smk-1)AnticipatedTopline dataNCT07223840

Clinical trials in Tobacco use disorder

NCT07223840Phase 2Recruitingn=222

A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse (RENEW-Smk-1)

Started Nov 2025· Primary completion Feb 2027

mixed

Formulations

Formulation	Route	Regimen	Pharmacokinetics
Brenipatide subcutaneous	Subcutaneous	—	—

Mechanism of action (compound-wide)

Dual agonist of the glucagon-like peptide-1 receptor (GLP-1R) and glucose-dependent insulinotropic polypeptide receptor (GIPR).

Target	Action	Affinity
Glucagon-like peptide 1 receptorprimaryGLP1R	Agonist	—ⓘ
Gastric inhibitory polypeptide receptorGIPR	Agonist	—ⓘ

← Full Brenipatide compound page (identity, identifiers, all indications)

Sources

ClinicalTrials.gov NCT07219953: A Study of Brenipatide in Participants With Alcohol Use Disorder (RENEW-ALC-2) — ClinicalTrials.gov
ClinicalTrials.gov NCT07219966: A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder (RENEW-ALC-1) — ClinicalTrials.gov
ClinicalTrials.gov NCT07223840: A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse (RENEW-Smk-1) — ClinicalTrials.gov
ClinicalTrials.gov NCT07286175: A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1) — ClinicalTrials.gov
ClinicalTrials.gov NCT07410507: A Study of Brenipatide in Adult Participants With Schizophrenia (RENEW-Scz-1) — ClinicalTrials.gov
ClinicalTrials.gov NCT07412756: A Study of Brenipatide in Adult Participants With Major Depressive Disorder (RENEW-MDD-1) — ClinicalTrials.gov
ClinicalTrials.gov NCT07420283: A Study of Brenipatide in Participants With Opioid Use Disorder (RENEW-Op-1) — ClinicalTrials.gov
ClinicalTrials.gov NCT07775300: A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder (RENEW-MDD-2) — ClinicalTrials.gov
Eli Lilly Q2 2026 earnings presentation (pipeline as of Aug 3, 2026; brenipatide trial table sourced from CT.gov Jul 30, 2026) — Company press release
GEN: Lilly's GIP/GLP-1 candidate brenipatide shows early clinical promise (Psych Congress 2026 posters) — News