Lilly buys AtaiBeckley·$3.8bnOtsuka buys Transcend·$1.2bnAbbVie buys Gilgamesh·$1.2bnatai buys Beckley Psytech·terms undisclosedAbbVie takes an option on Gilgamesh·$2bnLilly buys AtaiBeckley·$3.8bnOtsuka buys Transcend·$1.2bnAbbVie buys Gilgamesh·$1.2bnatai buys Beckley Psytech·terms undisclosedAbbVie takes an option on Gilgamesh·$2bnLilly buys AtaiBeckley·$3.8bnOtsuka buys Transcend·$1.2bnAbbVie buys Gilgamesh·$1.2bnatai buys Beckley Psytech·terms undisclosedAbbVie takes an option on Gilgamesh·$2bn
Next issueIssue 16 · Tue 29 Sep 

Assets

brenipatide (LY3537031)

Lilly

Molecule class
NOT VERIFIED. No pharmacology source read. Confirmed only that it matches none of our fourteen psychedelic count terms and is not BPL-003 or VLS-01.
Mechanism
Not stated in any Lilly filing read. 10-K FY2025 pipeline line: 'Brenipatide Alcohol use disorder Phase 3 Phase 3 trial was initiated.' 10-Q Q1 2026 and 10-Q Q2 2026: 'A Phase 3 trial was initiated for brenipatide for major depressive disorder.' No mechanism, class or receptor named in the 10-K or either 10-Q (checked 2026-09-05 for orexin, kappa, 5-HT2A, psychedelic, neuroplastogen: 0 hits). Registry NCT07775300 lists the intervention as 'Administered SC.' Classified non_psychedelic_comparator because it matches none of the fourteen COUNT_TERMS in monitor/terms.py and is subcutaneous. Previous value: not_checked.
Phase
Phase 3 in MDD (two pivotals) and alcohol use disorder (two pivotals); Phase 2 in bipolar disorder, IBS-D, IBS-C and asthma (CTIS 2025-522640-41-00, 52-week, authorised DE and FR 2026-01-21, PL 2026-01-30, NL 2026-02-02; recruitment started PL 2026-02-18)
Indication
major depressive disorder; alcohol use disorder; bipolar disorder; irritable bowel syndrome (IBS-D, IBS-C); uncontrolled moderate to severe asthma
Sponsor geography
US
Next catalyst
NCT07775300 moves to RECRUITING; resolves the Issue 11 call, by 2026-12-31
IP status
Not checked. Recorded as unchecked rather than left blank.

The catalyst above is recorded as inferred, not verified. It is this publication's reading of the company's guidance, not a date the company has published.

euclinicaltrials.euregistryverified 2026-09-15

Registered trials

  • NCT07286175ClinicalTrials.gov

    PHASE2 · Bipolar Disorder · RECRUITING · Argentina, Brazil, China, India, Japan, Mexico, Puerto Rico, United States

    clinicaltrials.govctgov registryverified 2026-08-31

  • NCT07412756ClinicalTrials.gov

    PHASE3 · Depressive Disorder, Major · RECRUITING · Australia, Brazil, Canada, China, Germany, Greece, Japan, Mexico, Poland, Puerto Rico, South Korea, Spain, Taiwan, United Kingdom, United States

    clinicaltrials.govctgov registryverified 2026-08-31

  • NCT07775300ClinicalTrials.gov

    PHASE3 · Depressive Disorder, Major · NOT_YET_RECRUITING · Australia, Brazil, Canada, China, Germany, Greece, Japan, Mexico, Poland, Puerto Rico, South Korea, Spain, Taiwan, United Kingdom, United States

    clinicaltrials.govctgov registryverified 2026-08-31

  • 2025-522310-24-00CTIS

    Therapeutic confirmatory (Phase III) · Depressive Disorder, Major · Authorised · Germany, Greece, Poland, Spain

    euclinicaltrials.euctis registryverified 2026-08-31

  • 2025-522312-16-00CTIS

    Therapeutic confirmatory (Phase III) · Alcohol Use Disorder · Authorised · Belgium, Germany

    euclinicaltrials.euctis registryverified 2026-09-15

  • 2025-522313-38-00CTIS

    Therapeutic confirmatory (Phase III) · Alcohol Use Disorder · Authorised · Belgium, Germany

    euclinicaltrials.euctis registryverified 2026-08-31

  • 2025-524973-17-00CTIS

    Therapeutic exploratory (Phase II) · Irritable Bowel Syndrome Diarrhea · Authorised · Belgium, Germany, Poland, Spain

    euclinicaltrials.euctis registryverified 2026-08-31

  • 2025-524974-41-00CTIS

    Therapeutic exploratory (Phase II) · Irritable Bowel Syndrome - Constipation · Authorised · Belgium, Spain

    euclinicaltrials.euctis registryverified 2026-08-31

  • 2025-522640-41-00CTIS

    Therapeutic exploratory (Phase II) · Uncontrolled moderate to severe asthma · Authorised · Germany, France, Netherlands, Poland

    euclinicaltrials.euctis registryverified 2026-09-15

In the briefing

Issues tagged LILLY, the owner of this asset.