bretisilocin (GM-2505) / Gilgamesh Pharma, AbbVie - LARVOL DELTA

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