AbbVieNYSE: ABBV
AbbVie (NYSE: ABBV) is a global biopharmaceutical company and one of the first large pharma entrants in next-generation psychedelic medicine. In May 2024, AbbVie partnered with Gilgamesh Pharmaceuticals ($65M upfront, up to $1.95B in milestones) to develop novel CNS therapies including neuroplastogens. In August 2025, AbbVie acquired bretisilocin (GM-2505) — a short-acting IV serotonergic psychedelic (DMT analog) from Gilgamesh — for up to $1.2B, marking one of the largest psychedelic drug deals in history. Bretisilocin's Phase 2a data showed a -21.6 point MADRS reduction at Day 14 (p=0.003). AbbVie continues to collaborate with Gilgamesh Pharma Inc. (Gilgamesh's spin-off) on earlier-stage programmes.
Development Programmes
2Bretisilocin (GM-2505)
DMTBretisilocin (GM-2505, 5-fluoro-N-methyl-N-ethyltryptamine / 5F-MET) is a next-generation 5-HT2A receptor agonist serotonergic psychedelic developed by Gilgamesh Pharmaceuticals and acquired by AbbVie (completed October 17, 2025, up to $1.2B). IV infusion (~10 mg), designed for a shorter psychedelic duration than psilocybin with extended antidepressant benefit. Phase 2a (NCT06236880, n=40 MDD): −21.6-point MADRS change at Day 14 for 10 mg vs −12.1 for 1 mg comparator. No serious adverse events.
Programme Tracker
Major Depressive Disorder (MDD)
Forecast
Phase II started - Approval eventual: 40%
Phase 2a complete with positive results. AbbVie now owns the asset and is planning next development steps following $1.2B acquisition of Gilgamesh.
Milestones
Phase II topline
CompletedActual: May 1, 2025
Phase 2a (NCT06236880) positive results: bretisilocin 10 mg produced −21.6-point MADRS change at Day 14 vs −12.1 for low-dose comparator (n=40 MDD). No serious adverse events.
Why it matters: Strong Phase 2a signal attracted $1.2B AbbVie acquisition; competitive MADRS result relative to psilocybin clinical benchmarks
Watch next: AbbVie Phase 2b/3 programme design and initiation
Company milestone
CompletedActual: Oct 17, 2025
AbbVie completed acquisition of Gilgamesh Pharmaceuticals / bretisilocin for up to $1.2B ($65M upfront option in 2024; deal announced August 25, 2025)
Why it matters: AbbVie's resources, regulatory expertise, and commercial infrastructure dramatically de-risk bretisilocin's development path; signals major pharma confidence in next-gen psychedelics for MDD
Watch next: AbbVie IND filing and Phase 2b programme initiation for bretisilocin
Recorded Events
Oct 17, 2025: Company milestone
May 1, 2025: Phase II topline
Evidence Links
trial-registry - ClinicalTrials.gov - Verified
company-website - AbbVie - Verified
GM-5022
GM-5022 is a non-hallucinogenic oral neuroplastogen from the Gilgamesh platform, targeting depression and anxiety via mechanisms distinct from 5-HT2A agonism. IND-enabling/preclinical stage. May be retained by Gilgamesh Pharma Inc. (the spin-out entity) following the AbbVie acquisition of bretisilocin.
Quick Facts
- Type
- Big Pharma
- Ticker
- NYSE: ABBV
- Lead Stage
- Phase II
- HQ
- 1 North Waukegan Road, North Chicago, IL 60064, USA, United States
- Website
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