Gilgamesh Pharmaceuticals

Gilgamesh Pharmaceuticals is a clinical-stage biotechnology company developing novel psychedelic-derived compounds for treatment-resistant depression, anxiety, and stress-related psychiatric disorders — pursuing a drug discovery approach that modifies psychedelic molecular structures to optimize therapeutic effects (efficacy, duration) while retaining or modifying the subjective psychedelic experience. Founded by Jonathan Sporn MD, Dalibor Sames PhD, Andrew Kruegel PhD, Jeff Witkin PhD, and Mike Cunningham PhD, Gilgamesh was the first Y Combinator-backed company in the psychedelic therapeutics space.\n\nGilgamesh's lead compound bretisilocin (GM-2505) is a novel psilocybin-derived molecule in Phase 2 clinical trials for major depressive disorder, positioned as a potential best-in-class psychedelic compound with optimized pharmacokinetics. The company's scientific founders from Columbia University brought expertise in psychedelic pharmacology and medicinal chemistry that enables rational drug design rather than simply repurposing existing natural psychedelics like psilocybin. The differentiated compound IP strategy creates defensible pharmaceutical assets rather than relying on natural compound exclusivity.\n\nIn 2025, Gilgamesh competes in the psychedelic medicine market with COMPASS Pathways (psilocybin for treatment-resistant depression, furthest along in clinical trials), Usona Institute (psilocybin non-profit research), MindMed (LSD and MDMA derivatives), and Lykos Therapeutics (MDMA-assisted therapy) for psychedelic-derived psychiatric treatment development. The FDA declined to approve MDMA-assisted therapy in 2024 (Lykos), creating caution around psychedelic clinical timelines, while COMPASS continues Phase 3 trials for psilocybin. Gilgamesh's novel compound approach (not psilocybin itself) provides a distinct regulatory and IP path. The 2025 strategy focuses on Phase 2 data readouts for bretisilocin, building clinical evidence for the compound's differentiated profile, and advancing toward a Phase 3 pivotal trial design.