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LY3537031
LY3537031 is a GLP-1/GIP receptor dual agonist Small molecule drug developed by Eli Lilly and Company. It is currently in Phase 3 development for Type 2 diabetes mellitus, Obesity or weight management. Also known as: Brenipatide.
LY3537031 is a GLP-1 and GIP receptor dual agonist that activates both incretin pathways to improve glucose control and promote weight loss.
LY3537031 is a compound studied in clinical trials, including those for asthma, renal impairment, and end stage renal disease. It is a dual agonist of glucagon-like peptide-1 (GLP-1) receptors and gastric inhibitory polypeptide (GIP) receptors, similar to brenipatide.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Eli Lilly and Company is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | LY3537031 |
|---|---|
| Also known as | Brenipatide |
| Sponsor | Eli Lilly and Company |
| Drug class | GLP-1/GIP receptor dual agonist |
| Target | GLP-1R, GIPR |
| Modality | Small molecule |
| Therapeutic area | Diabetes, Obesity |
| Phase | Phase 3 |
Mechanism of action
By simultaneously activating GLP-1 and GIP receptors, LY3537031 enhances insulin secretion in response to glucose, slows gastric emptying, and increases satiety. This dual mechanism produces greater glycemic control and weight reduction compared to single GLP-1 agonists. The drug is being developed as a once-weekly injectable for metabolic disorders.
Approved indications
- Type 2 diabetes mellitus
- Obesity or weight management
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Gastrointestinal disorders
Key clinical trials
- A Study of Brenipatide in Adult Participants With Schizophrenia (PHASE2)
- A Study of Brenipatide in Adult Participants With Major Depressive Disorder (PHASE3)
- A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma (PHASE2)
- A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder (PHASE3)
- A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse (PHASE2)
- A Study of Brenipatide in Participants With Alcohol Use Disorder (PHASE3)
- A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1) (PHASE2)
- A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- LY3537031 CI brief — competitive landscape report
- LY3537031 updates RSS · CI watch RSS
- Eli Lilly and Company portfolio CI
Frequently asked questions about LY3537031
What is LY3537031?
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What is LY3537031 used for?
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Is LY3537031 also known as anything else?
What drug class is LY3537031 in?
What development phase is LY3537031 in?
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What does LY3537031 target?
Related
- Drug class: All GLP-1/GIP receptor dual agonist drugs
- Target: All drugs targeting GLP-1R, GIPR
- Manufacturer: Eli Lilly and Company — full pipeline
- Therapeutic area: All drugs in Diabetes, Obesity
- Indication: Drugs for Type 2 diabetes mellitus
- Indication: Drugs for Obesity or weight management
- Also known as: Brenipatide
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing