Brenipatide

Phase 3Peptide

Eli Lilly

Brenipatide is one of 173 small molecule programs targeting Asthma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

172

Competitors

Pipeline

Status by Indication[3][1]

Indication

AsthmaActive, not recruiting

Major Depressive DisorderActive, not recruiting

SchizophreniaActive, not recruiting

Bipolar DisorderActive, not recruiting

Depressive Disorder, MajorRecruiting

Opioid Use DisorderActive, not recruiting

AsthmaPhase 2

Active, not recruiting

Major Depressive DisorderPhase 3

Active, not recruiting

SchizophreniaPhase 2

Active, not recruiting

Bipolar DisorderPhase 2

Active, not recruiting

Depressive Disorder, MajorPhase 3

Recruiting

Opioid Use DisorderPhase 2

Active, not recruiting

Competition

Competitive Landscape

1050 competitors in Asthma

#DrugCompanyPhaseTrials

Brenipatide

Eli Lilly

Phase 3

1 2

Singulair

AstraZeneca

Preclinical

17 3

Cinqair

Teva

Preclinical

13 4

Dupixent

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

30 5

Qvar

Chiesi Farmaceutici S.p.A.

Preclinical

8 6

Atrovent

Boehringer Ingelheim

Preclinical

5 7

Arcoxia

Symbicort

6 9

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

1 10

Decadron

QQuince Therapeutics S.p.A.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Recruiting

Smoking Cigarette

NCT07223840

Phase 1Not yet recruiting

Overweight

NCT07476118

Q4 2027

Phase 2Recruiting

Schizophrenia

NCT07410507

Phase 2Recruiting

Bipolar Disorder

NCT07286175

Q1 2028

Phase 3Recruiting

Depressive Disorder, Major

NCT07412756

Phase 2Recruiting

Opioid Use Disorder

NCT07420283

Clinical

Trials by Indication[1]

Smoking Cigarette1 trial

A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse

Recruiting· Eli Lilly logo

Eli Lilly·Phase 2·NCT07223840·222 enrolled

Overweight1 trial

A Study of Brenipatide (LY3537031) in Healthy Participants With Overweight or Obesity

Not yet recruiting· Eli Lilly logo

Eli Lilly·Phase 1·NCT07476118·150 enrolled

Opioid Use Disorder1 trial

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study With a Separate Open-label Cohort to Evaluate the Efficacy and Safety of Brenipatide as Adjunctive Treatment to Transmucosal Buprenorphine With or Without Naloxone in Early Recovery of Participants With Opioid Use Disorder (RENEW-Op-1)

Recruiting· Eli Lilly logo

Eli Lilly·Phase 2·NCT07420283·465 enrolled

Depressive Disorder, Major1 trial

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Delaying Time to Relapse Compared With Placebo in Adult Participants With Major Depressive Disorder (RENEW-MDD 1)

Recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT07412756·1,000 enrolled

Asthma1 trial

A Phase 2, Multicenter, Randomized, Double-blind, 52-week Study, to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Uncontrolled Moderate to Severe Asthma

Recruiting· Eli Lilly logo

Eli Lilly·Phase 2·NCT07219173·531 enrolled

2 more indications

Schizophrenia1 trial

A Phase 2 Multicenter, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Adult Participants With Schizophrenia (RENEW-Scz-1)

Recruiting· Eli Lilly logo

Eli Lilly·Phase 2·NCT07410507·450 enrolled

Bipolar Disorder1 trial

A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Delaying Time to Relapse Compared With Placebo in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)

Recruiting· Eli Lilly logo

Eli Lilly·Phase 2·NCT07286175·400 enrolled

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for Brenipatide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Brenipatide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Brenipatide. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Eli Lilly company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Peptide[2]
Highest Phase: Phase 3[1]
Company: Eli Lilly

Brenipatide

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q4 2027

Q1 2028

Trials by Indication[1]

Smoking Cigarette1 trial

Overweight1 trial

Opioid Use Disorder1 trial

Depressive Disorder, Major1 trial

Asthma1 trial

Schizophrenia1 trial

Bipolar Disorder1 trial

References

Drug Info

Quick Facts

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