Gilgamesh touts positive Phase IIa results for GM-2505 in MDD

New York-based neurosciences company Gilgamesh Pharmaceuticals yesterday announced Phase IIa results for GM-2505, a novel, rapid-acting 5-HT2A receptor agonist and 5-HT releaser in development for the treatment of patients with moderate-to-severe major depressive disorder (MDD).

The Phase IIa trial was a randomized, double-blind study evaluating the efficacy, safety, and durability of GM-2505 in MDD patients (n=40). Patients were randomized to receive either 10mg GM-2505 or a low-dose psychoactive comparator of 1mg GM-2505 via intravenous (IV) infusion on Day 1. All patients were then administered a second dose of 15mg GM-2505 on Day 15.

The global market for MDD treatment is substantial and projected to continue growing. In 2025, the market was estimated to be worth around $22.92 billion, with the USA being the largest revenue generator. This growth is expected to continue, with the market potentially reaching $23.56 billion by 2029, according to a Statista report.