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Lead program: Phase II
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Research, Drug Development & Manufacturing

AbbVieNYSE: ABBV

Data updated

1 North Waukegan Road, North Chicago, IL 60064, USA, United States
2 Drug Candidates

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.

Pipeline Intelligence

Developer Momentum

Programme tracker
Active candidates
2

All tracked candidates active

Active programmes
2

All tracked programmes active

Lead stage
Phase II

Multiple active stages

Forecast coverage
2 of 2

2 active programmes with forecast fields

Latest sourced update

AbbVie Neuroscience Pipeline

Jun 27, 2026 - company-website - AbbVie - Bretisilocin (GM-2505)

Next known catalyst

Phase II topline

Q4 2026 - Bretisilocin (GM-2505) / Bretisilocin — Phase 2a MDD (AbbVie/Gilgamesh) - Confidence: 60%

9 sources0 pipeline-linked trials0 pipeline-linked papers1 Phase II1 Preclinical

Development Programmes

2

Bretisilocin (GM-2505)

DMT
Phase II
Major Depressive Disorder (MDD)

Bretisilocin (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 in October 2025. The Phase 2a MDD programme includes the positive initial GM-2505 readout and an expanded/recruiting registry study (NCT06236880, estimated n=124) with estimated primary completion in October 2026.

Programme Tracker

Major Depressive Disorder (MDD)

Primary: US (FDA)
Phase IIActive

Forecast

Phase II topline - Likely: Q4 2026 - Approval eventual: 40%

AbbVie completed its acquisition of bretisilocin in October 2025. NCT06236880 remains recruiting as an expanded Phase 2a MDD study, with ClinicalTrials.gov listing 124 estimated participants and estimated primary completion in October 2026.

Milestones

Phase II topline

Completed

Actual: 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

Gilgamesh GM-2505 Phase 2a Positive Results (Psychedelic Alpha)(Press release)[Verified]

Company milestone

Completed

Actual: 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

AbbVie — Acquires Gilgamesh Pharmaceuticals Bretisilocin for up to $1.2B(Press release)[Verified]

Recorded Events

Oct 17, 2025: Company milestone

May 1, 2025: Phase II topline

Evidence Links

NCT06236880 — GM-2505 Phase 2a Study (MDD)

clinical-trial-registry - ClinicalTrials.gov - Feb 9, 2026 - Verified

ClinicalTrials.gov registry for GM-2505-201; last update posted 2026-02-09, recruiting with estimated primary completion in October 2026.

AbbVie Neuroscience Pipeline

company-website - AbbVie - Jun 27, 2026 - Verified

AbbVie completes acquisition of Gilgamesh bretisilocin

company-press-release - AbbVie - Oct 17, 2025 - Verified

Official AbbVie release confirming acquisition close and bretisilocin Phase 2 development status.

GM-5022

Preclinical
Depressive Disorders

AbbVie-partnered Gilgamesh non-hallucinogenic neuroplastogen programme for depression and anxiety. GM-5022 has been described externally as an oral, non-hallucinogenic neuroplastogen in early development, while current Gilgamesh materials group the asset class as Neuroplastogens under the AbbVie partnership.

Programme Tracker

Depressive Disorders

Primary: US (FDA)
Pre-clinicalActive

Forecast

Pre-clinical completed

Preclinical AbbVie-partnered neuroplastogen programme. AbbVie/Gilgamesh collaboration remains active after AbbVie acquired only bretisilocin; Gilgamesh now presents the class as non-hallucinogenic Neuroplastogens for depression and anxiety.

Milestones

Discovery started

Completed

Actual: May 13, 2024

AbbVie and Gilgamesh entered a collaboration and option-to-license agreement for next-generation neuroplastogens in psychiatric disorders.

Why it matters: Links the GM-5022/neuroplastogen class to a Big Pharma discovery and development option rather than an isolated internal programme.

Watch next: Named candidate update, IND-enabling disclosure, option exercise, or first clinical trial registration.

AbbVie and Gilgamesh Announce Collaboration and Option-to-License Agreement(Press release)[Verified]

Pre-clinical started

In progress

Actual: Mar 24, 2026

Gilgamesh Pharma reported that the AbbVie neuroplastogen collaboration continues and that broader pipeline programmes are moving toward IND-enabling and early clinical development.

Why it matters: Confirms the programme remained active after the 2025 bretisilocin acquisition and spin-out.

Watch next: Clinical candidate nomination or IND filing.

Gilgamesh Pharma Closes $60 Million Series A(Press release)[Verified]

Recorded Events

Mar 24, 2026: Pre-clinical started

May 13, 2024: Discovery started

Evidence Links

AbbVie and Gilgamesh Announce Collaboration and Option-to-License Agreement

Press release - AbbVie - May 13, 2024 - Verified

Collaboration covers next-generation neuroplastogens for psychiatric disorders.

AbbVie to Acquire Bretisilocin; Neuroplastogen Option Remains in Effect

Press release - AbbVie - Aug 25, 2025 - Verified

AbbVie states the 2024 neuroplastogen option remains in effect and transfers to Gilgamesh Pharma Inc. after the bretisilocin spin-out.

Gilgamesh Pharma Closes $60 Million Series A

Press release - PR Newswire - Mar 24, 2026 - Verified

Gilgamesh says it continues the AbbVie collaboration to develop neuroplastogen therapeutics; additional internal programmes are moving toward IND-enabling and early clinical development.

Gilgamesh Pharma - Pipeline

company-website - Gilgamesh Pharma - Jun 26, 2026 - Verified

Current pipeline lists Neuroplastogens as non-hallucinogenic AbbVie-partnered NCEs for depression and anxiety.

Similar Developers

Reference points selected from shared pipeline stage, indications, compounds, regulatory pathways, and evidence footprint.

View landscape
Delix Therapeutics
Phase II2 active candidates1 paper
same indication: Major Depressive Disorder (MDD)Phase II peer2 overlapping stagessame regulator: US FDA
Helus Pharma
Phase III2 active candidates
shared compound: DMTsame indication: Major Depressive Disorder (MDD)same regulator: US FDAsame country: United States
Biomind Labs
Phase II2 active candidates3 trials
same indication: Major Depressive Disorder (MDD)Phase II peer2 overlapping stagessame regulator: US FDA
Gilgamesh Pharma
Phase II4 active candidates
same indication: Major Depressive Disorder (MDD)Phase II peer2 overlapping stagessame regulator: US FDA

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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