Ozmosi | Brenipatide Drug Profile
Drug Profile
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Brenipatide

Pronounced as: bren-ih-pa-tide

Alternative Names: Brenipatide, ly-3537031, ly 3537031, ly3537031
Clinical Status: Active
Latest Update: 2026-09-16
Latest Update Note: Clinical Trial Update

Product Description

Brenipatide (GIP/GLP-1 Coagonist III) is a biologic entity being studied for the treatment of cardiometabolic-related diseases. (Sourced from: https://www.lilly.com/science/research-development/pipeline)

Mechanisms of Action: GIP Agonist, GLP-1 Agonist

Novel Mechanism: No

Modality: Peptide/Protein

Route of Administration: Subcutaneous

FDA Designation: *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Company: Eli Lilly
Company Location: Eastern America
Company Founding Year: 1876
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Brenipatide

Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Japan, Mexico, Netherlands, New Zealand, Poland, Puerto Rico, Romania, Singapore, Slovakia, South Korea, Spain, Taiwan, United Kingdom, United States, Unknown Location

Active Clinical Trial Count: 36

Recent & Upcoming Milestones

Highest Development Phases

Phase 3: Alcoholism|Depressive Disorder, Major

Phase 2: Asthma|Bipolar Disorder|Bronchitis, Chronic|Chronic Obstructive Pulmonary Disease|Constipation|Diarrhea|Emphysema|Irritable Bowel Syndrome|Opioid-Related Disorders|Schizophrenia|Tobacco Use Disorder

Phase 1: Healthy Volunteers|Hepatic Insufficiency|Kidney Failure, Chronic|Obesity|Overweight

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

NCT07759245

RENEW-COPD

P2

Not yet recruiting

Chronic Obstructive Pulmonary Disease|Bronchitis, Chronic|Emphysema

2028-05-01

79%

2026-08-13

Primary Endpoints|Treatments

NCT07219173

J2S-MC-GZMR

P2

Recruiting

Asthma

2028-04-01

73%

2025-10-28

NCT07420283

RENEW-Op-1

P2

Recruiting

Opioid-Related Disorders

2028-03-01

79%

2026-04-24

Primary Completion Date|Primary Endpoints|Study Completion Date

NCT07219953

RENEW-ALC-2

P3

Recruiting

Alcoholism

2028-04-01

53%

2025-11-25

Primary Endpoints|Start Date|Treatments|Trial Status

NCT07412756

RENEW-MDD-1

P3

Recruiting

Depressive Disorder, Major

2028-02-01

66%

2026-03-24

Primary Endpoints|Start Date|Treatments|Trial Status

NCT07286175

RENEW-Bipolar-1

P2

Recruiting

Bipolar Disorder

2027-11-01

76%

2025-12-17

Primary Endpoints|Treatments

NCT07410507

RENEW-Scz-1

P2

Recruiting

Schizophrenia

2027-11-01

77%

2026-03-26

Primary Endpoints|Start Date|Treatments|Trial Status

NCT07545759

RENEW-IBS-D

P2

Recruiting

Irritable Bowel Syndrome|Diarrhea

2027-09-01

81%

2026-05-14

NCT07545772

RENEW-IBS-C

P2

Recruiting

Irritable Bowel Syndrome|Constipation

2027-07-01

79%

2026-07-08

NCT07223840

RENEW-Smk-1

P2

Recruiting

Tobacco Use Disorder

2027-02-01

71%

2025-11-25

Primary Endpoints|Start Date|Treatments|Trial Status

NCT06606106

J2S-MC-GZMD

P1

Active, not recruiting

Overweight|Obesity

2026-07-01

88%

2026-01-21

NCT07165002

J2S-MC-GZML

P1

Recruiting

Hepatic Insufficiency

2026-08-01

2025-11-19

Primary Endpoints|Start Date|Treatments|Trial Status

NCT07165015

J2S-MC-GZMM

P1

Completed

Kidney Failure, Chronic

2026-04-16

50%

2026-04-28

Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status

jRCT2071250111

jRCT2071250111

P3

Not yet recruiting

Alcoholism

2028-03-31

jRCT2031260413

jRCT2031260413

P2

Not yet recruiting

Chronic Obstructive Pulmonary Disease

2028-12-05

jRCT2071250095

jRCT2071250095

P2

Not yet recruiting

Asthma

2028-10-16

2026-525480-41-00

J2S-MC-GZMV

P2

Not yet recruiting

Chronic Obstructive Pulmonary Disease

2028-09-05

79%

2025-522640-41-00

J2S-MC-GZMR

P2

Not yet recruiting

Asthma

2028-06-16

jRCT2021250043

jRCT2021250043

P2

Not yet recruiting

Bipolar Disorder

2028-03-31

jRCT2051260167

jRCT2051260167

P3

Not yet recruiting

Depressive Disorder, Major

2029-01-31

NCT07775300

RENEW-MDD- 2

P3

Not yet recruiting

Depressive Disorder, Major

2028-12-01

66%

2026-08-21

2025-522310-24-00

J2S-MC-GZMI

P3

Not yet recruiting

Depressive Disorder, Major

2028-05-28

66%

NCT07219966

RENEW-ALC-1

P3

Recruiting

Alcoholism

2028-04-01

53%

2025-12-05

Primary Endpoints|Start Date|Treatments|Trial Status

2025-522313-38-00

J2S-MC-GZME

P3

Not yet recruiting

Alcoholism

2028-04-01

53%

2025-522312-16-00

J2S-MC-GZMP

P3

Not yet recruiting

Alcoholism

2028-04-01

53%

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