Peptide · Brenipatide

Brenipatide

Long-acting lipidated synthetic peptide dual agonist of the GLP-1 and GIP receptors (tirzepatide class) from Eli Lilly (LY3537031), developed in neuroscience (AUD, OUD, tobacco use disorder, MDD, bipolar disorder, schizophrenia) and immunology/GI indications. Lilly says it is designed to engage GIP/GLP-1 receptors in CNS reward and inflammatory pathways.

Also known as: brenipatide, LY3537031, LY-3537031, 2408921-49-1

Data current as of 1 Apr 2028

Key facts

Modality: Peptide
Chemical class: incretin analogue, lipidated peptide
Chemistry: Other
Mechanism: Glucagon-like peptide 1 receptor agonist
Highest phase: Phase 3
Lead indication: Alcohol use disorder
Developer: Eli Lilly and Company (LLY)
Trials: 8 tracked · 8 recruiting · 671 sites
Next catalyst: Primary completion Feb 2027 (RENEW-Smk-1) — Topline data (Tobacco use disorder)

Mechanism of action#

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	—ⓘ

Formulations#

Formulation	Route	Regimen	Pharmacokinetics
Brenipatide subcutaneous	Subcutaneous	—	—

Development timeline#

Phase change Readout Event UpcomingHover a marker for details.

Phase 3Oct 2025 – Apr 2028

Apr 2028
UpcomingAlcohol use disorder ↗
Apr 2028
UpcomingAlcohol use disorder ↗
Feb 2028
UpcomingMajor depressive disorder ↗
Sept 2026
Conference presentationConference Presentation↗
Aug 2026
Trial startedTrial Started
Feb 2026
Trial startedTrial Started
Feb 2026
Trial startedTrial Started
Feb 2026
Programme became clinically active with first patient-trial start in this indication; all trials recruiting as of Oct 2026.Major depressive disorder
Feb 2026
Trial startedTrial Started
Nov 2025
Trial startedTrial Started
Nov 2025
Trial startedTrial Started
Oct 2025
Trial startedTrial Started
Oct 2025
Programme became clinically active with first patient-trial start in this indication; all trials recruiting as of Oct 2026.Alcohol use disorder
Oct 2025
Trial startedTrial Started

Phase 2Nov 2025 – Mar 2028

Mar 2028
UpcomingOpioid use disorder ↗
Nov 2027
UpcomingBipolar disorder ↗
Nov 2027
UpcomingSchizophrenia ↗
Feb 2027
UpcomingTobacco use disorder ↗
Feb 2026
Programme became clinically active with first patient-trial start in this indication; all trials recruiting as of Oct 2026.Opioid use disorder
Feb 2026
Programme became clinically active with first patient-trial start in this indication; all trials recruiting as of Oct 2026.Schizophrenia
Nov 2025
Programme became clinically active with first patient-trial start in this indication; all trials recruiting as of Oct 2026.Bipolar disorder
Nov 2025
Programme became clinically active with first patient-trial start in this indication; all trials recruiting as of Oct 2026.Tobacco use disorder

Brenipatide for Alcohol use disorder #

Phase 3ActiveAlcohol use disorder indication →

Preclinical

Phase 1

Phase 2

Phase 3

Filed

Approved

Two 56-week Phase 3 placebo-controlled trials (RENEW-ALC-1/-2, ~1,100 each, 8 countries) of brenipatide in AUD with change in drinking patterns (TLFB) as primary endpoint. Lilly advanced directly from Phase 1 to Phase 3 in AUD.

Readouts

Primary completion Apr 2028 (RENEW-ALC-1)AnticipatedTopline dataNCT07219966
Primary completion Apr 2028 (RENEW-ALC-2)AnticipatedTopline dataNCT07219953

Brenipatide for Bipolar disorder #

Phase 2ActiveBipolar disorder indication →

Preclinical

Phase 1

Phase 2

Phase 3

Filed

Approved

Phase 2 adjunctive relapse-prevention trial (RENEW-Bipolar-1, n~400) of brenipatide + SoC vs placebo + SoC in bipolar I/II disorder; primary endpoint time to relapse.

Readouts

Primary completion Nov 2027 (RENEW-Bipolar-1)AnticipatedTopline dataNCT07286175

Brenipatide for Schizophrenia #

Phase 2ActiveSchizophrenia indication →

Preclinical

Phase 1

Phase 2

Phase 3

Filed

Approved

Phase 2 adjunctive trial (RENEW-Scz-1, n~450) of brenipatide in adults with schizophrenia; primary endpoint percent change in body weight in participants with baseline BMI >=25 kg/m2.

Readouts

Primary completion Nov 2027 (RENEW-Scz-1)AnticipatedTopline dataNCT07410507

Brenipatide for Opioid use disorder #

Phase 2ActiveOpioid use disorder indication →

Preclinical

Phase 1

Phase 2

Phase 3

Filed

Approved

Phase 2 trial (RENEW-Op-1, n~465) of brenipatide as adjunct to transmucosal buprenorphine (+/- naloxone) in early recovery from OUD, with a separate open-label cohort; primary endpoint % weeks abstinent.

Readouts

Primary completion Mar 2028 (RENEW-Op-1)AnticipatedTopline dataNCT07420283

Brenipatide for Tobacco use disorder #

Phase 2ActiveTobacco use disorder indication →

Preclinical

Phase 1

Phase 2

Phase 3

Filed

Approved

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.

Readouts

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

Brenipatide for Major depressive disorder #

Phase 3ActiveMajor depressive disorder indication →

Preclinical

Phase 1

Phase 2

Phase 3

Filed

Approved

Two Phase 3 adjunctive relapse-prevention trials (RENEW-MDD-1, ~1,000 pts in 14 countries; RENEW-MDD-2, goal 1,000) of brenipatide + standard of care vs placebo + SoC in MDD; primary endpoint time to relapse. Lilly reported Phase 3 initiation in its Q1 2026 results.

Readouts

Primary completion Feb 2028 (RENEW-MDD-1)AnticipatedTopline dataNCT07412756

Clinical trials#

NCT07775300J2S-MC-GZMIPhase 3Recruitingn=1000

A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder (RENEW-MDD-2)

Started Aug 2026

mixed

NCT07420283J2S-MC-GZMGPhase 2Recruitingn=465

A Study of Brenipatide in Participants With Opioid Use Disorder (RENEW-Op-1)

Started Feb 2026· Primary completion Mar 2028· 57 sites across 4 countries

United StatesUnited KingdomCanadaPuerto Rico

mixed

NCT07410507J2S-MC-GZMKPhase 2Recruitingn=450

A Study of Brenipatide in Adult Participants With Schizophrenia (RENEW-Scz-1)

Started Feb 2026· Primary completion Nov 2027· 103 sites across 7 countries

United StatesJapanArgentinaIndia

mixed

NCT07412756J2S-MC-GZMHPhase 3Recruitingn=1000

A Study of Brenipatide in Adult Participants With Major Depressive Disorder (RENEW-MDD-1)

Started Feb 2026· Primary completion Feb 2028· 186 sites across 15 countries

United StatesJapanChinaCanada

mixed

NCT07286175J2S-MC-GZMJPhase 2Recruitingn=400

A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)

Started Nov 2025· Primary completion Nov 2027· 87 sites across 8 countries

United StatesJapanIndiaArgentina

mixed

Show all 8 trials

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

NCT07219953J2S-MC-GZMPPhase 3Recruitingn=1100

A Study of Brenipatide in Participants With Alcohol Use Disorder (RENEW-ALC-2)

Started Oct 2025· Primary completion Apr 2028· 117 sites across 8 countries

United StatesChinaJapanSouth Korea

mixed

NCT07219966J2S-MC-GZMEPhase 3Recruitingn=1100

A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder (RENEW-ALC-1)

Started Oct 2025· Primary completion Apr 2028· 121 sites across 8 countries

United StatesChinaJapanSouth Korea

mixed

Conference coverage#

Brenipatide appears in 3 CNS Pulse conference abstracts:

Exploring novel treatment options for patients with psychiatric disorders: brenipatide clinical trials2026 ECNP Congress · Sylwia Janowska
Brenipatide, a glucose-dependent insulinotropic polypeptide/glucagon-like peptide 1 receptor agonist: clinical data supporting dose selection for neuropsychiatric and immunological indications2026 ECNP Congress · Paul Goldsmith
Exploring novel treatment options for patients with substance use disorders: brenipatide clinical trials2026 ECNP Congress · Anastasia Hoover

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

Key facts

Mechanism of action#

Formulations#

Development timeline#

Brenipatide for Alcohol use disorder#

Readouts

Brenipatide for Bipolar disorder#

Readouts

Brenipatide for Schizophrenia#

Readouts

Brenipatide for Opioid use disorder#

Readouts

Brenipatide for Tobacco use disorder#

Readouts

Brenipatide for Major depressive disorder#

Readouts

Clinical trials#

NCT07775300J2S-MC-GZMIPhase 3Recruitingn=1000

NCT07420283J2S-MC-GZMGPhase 2Recruitingn=465

NCT07410507J2S-MC-GZMKPhase 2Recruitingn=450

NCT07412756J2S-MC-GZMHPhase 3Recruitingn=1000

NCT07286175J2S-MC-GZMJPhase 2Recruitingn=400

NCT07223840Phase 2Recruitingn=222

NCT07219953J2S-MC-GZMPPhase 3Recruitingn=1100

NCT07219966J2S-MC-GZMEPhase 3Recruitingn=1100

Conference coverage#

Sources#

Brenipatide for Alcohol use disorder #

Brenipatide for Bipolar disorder #

Brenipatide for Schizophrenia #

Brenipatide for Opioid use disorder #

Brenipatide for Tobacco use disorder #

Brenipatide for Major depressive disorder #