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Brenipatide
Brenipatide is a Small molecule drug developed by Eli Lilly and Company. It is currently in Phase 3 development. Also known as: LY3537031.
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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 | Brenipatide |
|---|---|
| Also known as | LY3537031 |
| Sponsor | Eli Lilly and Company |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
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 Brenipatide (LY3537031) in Healthy Participants With Overweight or Obesity (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:
- Brenipatide CI brief — competitive landscape report
- Brenipatide updates RSS · CI watch RSS
- Eli Lilly and Company portfolio CI
Frequently asked questions about Brenipatide
What is Brenipatide?
Who makes Brenipatide?
Is Brenipatide also known as anything else?
What development phase is Brenipatide in?
Related
- Manufacturer: Eli Lilly and Company — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: LY3537031
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing