bretisilocin (ABBV-2505) / AbbVie - LARVOL DELTA

Next-Generation Pharmacotherapies for Unipolar Mood Disorders: A Leading Article on Phase II/III Drug Development Across Diverse Mechanisms. (PubMed, CNS Drugs) - "Following the US Food and Drug Administration (FDA) approval of esketamine and brexanolone in 2019, industry investment in therapeutics with novel mechanisms for mood and anxiety disorders has expanded, catalyzing a new wave of innovative interventions...The drug names discussed are ALTO-100, ALTO-203, ALTO-207, ALTO-300, BHV-7000, BI-1569912, BPL-003, COMP360, DT120, ELE-101, GATE-251, GH001, GM-1020, GM-2505, HLP003, MK-1942, NBI-1065845, NBI-1070770, NV-5138, PIPE-307, SEP-363856, SPT-300, VLS-01, and XEN1101. The US Clinical Trials registry (clinicaltrials.gov), MEDLINE, conference proceedings, and company communications such as press releases were consulted to obtain up-to-date trial information and reported outcomes. Overall, the therapeutic landscape shows an expanding range of clinical compounds under active development; nonetheless, persistent challenges remain, including approaches to therapeutics where functional unblinding may occur, the ways in which to..."

Journal • P2/3 data • Review • CNS Disorders • Mood Disorders • Psychiatry

GM-2505-201: A Phase 2a Study to Evaluate the Safety and Tolerability of GM-2505 in Patients With MDD (clinicaltrials.gov) - P2 | N=126 | Completed | Sponsor: Gilgamesh Pharmaceuticals | Recruiting ➔ Completed

Trial completion • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

A Study to Assess the Adverse Events and How Bretisilocin Intramuscular Injection Moves Through the Body of Healthy Adult Participants (clinicaltrials.gov) - P1 | N=26 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Adverse events • Enrollment closed

A Study to Assess the Adverse Events and How Bretisilocin Intramuscular Injection Moves Through the Body of Healthy Adult Participants (clinicaltrials.gov) - P1 | N=26 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Adverse events • Enrollment open

A Study to Assess the Adverse Events and How Bretisilocin Intramuscular Injection Moves Through the Body of Healthy Adult Participants (clinicaltrials.gov) - P1 | N=26 | Not yet recruiting | Sponsor: AbbVie

Adverse events • New P1 trial

GM-2505-201: A Phase 2a Study to Evaluate the Safety and Tolerability of GM-2505 in Patients With MDD (clinicaltrials.gov) - P2 | N=124 | Recruiting | Sponsor: Gilgamesh Pharmaceuticals | N=40 ➔ 124 | Trial completion date: Jul 2024 ➔ Oct 2026 | Trial primary completion date: Jul 2024 ➔ Oct 2026

Enrollment change • Trial completion date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

A novel psychedelic 5-HT2A receptor agonist GM-2505: The pharmacokinetic, safety, and pharmacodynamic profile from a randomized trial healthy volunteer. (PubMed, J Psychopharmacol) - "These PD findings were similar in nature and magnitude to other 5-HT2A receptor agonists that have been studied clinically. In line with the GM-2505 PK profile, the duration of cardiovascular and subjective effects was shorter than psilocybin but longer than DMT, demonstrating a potentially more practical temporal profile for use in a supervised clinical setting compared to longer-acting 5-HT2A receptor agonists, with an optimal dose range of 10-15 mg IV. Clinical trial (ISRCTN64428072) registration: https://www.isrctn.com/ISRCTN64428072."

Journal • PK/PD data • Cardiovascular • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Pharmacokinetic, pharmacodynamic and subjective and effects of the novel 5-HT2A receptor agonist GM-2505 in healthy volunteers (ECNP 2024) - "Both objective (resting state EEG, blood pressure, neurohormones) and robust subjective (TEAEs, 5D-ASC, MEQ-30) effects were consistent with expected dose-dependent effects of psychedelic 5-HT2A receptor agonists. In Conclusion , doses with clear psychedelic effects were identified that are being evaluated in the currently ongoing Phase 2a trial in patients with major depressive disorder."

Clinical • PK/PD data • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

GM-2505-201: A Phase 2a Study to Evaluate the Safety and Tolerability of GM-2505 in Patients With MDD (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Gilgamesh Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

GM-2505-201: A Phase 2a Study to Evaluate the Safety and Tolerability of GM-2505 in Patients With MDD (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Gilgamesh Pharmaceuticals

New P2 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry