Brenipatide

Phase 3Peptide

Eli Lilly

Brenipatide is one of 205 small molecule programs targeting Depressive Disorder, Major. It is currently in Phase 3.

Indications

Total Trials

Active Trials

204

Competitors

Pipeline

Status by Indication[3][1]

Indication

Depressive Disorder, MajorRecruiting

SmokingRecruiting

ObesityActive, not recruiting

Pulmonary Disease, Chronic ObstructiveNot yet recruiting

AsthmaRecruiting

SchizophreniaRecruiting

Bipolar DisorderRecruiting

Opioid Use DisorderRecruiting

Depressive Disorder, MajorPhase 3

Recruiting

SmokingPhase 2

Recruiting

ObesityPhase 1

Active, not recruiting

Pulmonary Disease, Chronic ObstructivePhase 2

Not yet recruiting

AsthmaPhase 2

Recruiting

SchizophreniaPhase 2

Recruiting

Bipolar DisorderPhase 2

Recruiting

Opioid Use DisorderPhase 2

Recruiting

Competition

Competitive Landscape

190 competitors in Obesity

#DrugCompanyPhaseTrials

Retatrutide

Eli Lilly

Phase 3

6 2

Decadron

AAspen Global Incorporated

Phase 3

2 3

Revlimid

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Phase 3

1 4

Enavogliflozin

Daewoong Pharmaceutical Co. LTD.

Phase 3

1 5

Brenipatide

Eli Lilly

Phase 3

1 6

Gemtesa

Sumitomo Pharma America, Inc.

Phase 3

1 7

Zenagamtide

Novo Nordisk

Phase 3

3 8

Berobenatide

Pfizer

Phase 3

3 9

Belantamab Mafodotin-Blmf

Novo Nordisk

Phase 3

1 10

Survodutide

Boehringer Ingelheim

Phase 3

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

Timeline

Expected Milestones

Q1 2027

Phase 2Recruiting

Smoking

NCT07223840

Phase 1Active, not recruiting

Obesity

NCT07476118

Q4 2027

Phase 2Recruiting

Bipolar Disorder

NCT07286175

Phase 2Recruiting

Schizophrenia

NCT07410507

Q1 2028

Phase 3Recruiting

Depressive Disorder, Major

NCT07412756

Phase 2Recruiting

Opioid Use Disorder

NCT07420283

Clinical

Trials by Indication[1]

Depressive Disorder, Major2 trials

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- 2)

Not yet recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT07775300·1,000 enrolled

Recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT07412756·1,000 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

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

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

Pulmonary Disease, Chronic Obstructive1 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 Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)

Not yet recruiting· Eli Lilly logo

Eli Lilly·Phase 2·NCT07759245·606 enrolled

3 more indications

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

Smoking1 trial

A Phase 2, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for Reduction in Risk of Relapse to Cigarette Smoking in Adults (RENEW-Smk-1)

Recruiting· Eli Lilly logo

Eli Lilly·Phase 2·NCT07223840·222 enrolled

Obesity1 trial

A Phase 1b, Randomized, Investigator- and Participant-Blinded, Placebo-Controlled Multiple-Dose Study to Evaluate the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Brenipatide in Healthy Participants With Overweight or Obesity

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 1·NCT07476118·150 enrolled

Sources

References

[1]
ClinicalTrials.gov — 9 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]

Depressive Disorder, Major2 trials

Bipolar Disorder1 trial

Opioid Use Disorder1 trial

Schizophrenia1 trial

Pulmonary Disease, Chronic Obstructive1 trial

Asthma1 trial

Smoking1 trial

Obesity1 trial

References

Drug Info

Quick Facts

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