AbbVie to Acquire Gilgamesh Pharmaceutical’s Psychedelic Drug for $1.2B

AbbVie has agreed to acquire Gilgamesh Pharmaceuticals Inc.’s lead investigational candidate, currently in clinical development for the treatment of patients with moderate-to-severe major depressive disorder (MDD), for up to $1.2 billion, inclusive of an upfront payment and development milestones.

Bretisilocin, a 5-HT2A receptor agonist and 5-HT releaser, is a novel, next-generation psychedelic compound that has been shown to exert a shorter duration of psychoactive experience, while retaining an extended therapeutic benefit.

A recent Phase 2a study of bretisilocin in MDD showed a significant reduction in depressive symptoms compared to a low-dose active comparator, with no serious adverse events.

“The field of psychiatry represents one of the most challenging areas in medicine, with a significant need for innovative solutions,” said Roopal Thakkar, M.D., EVP, research and development and chief scientific officer, AbbVie. “This acquisition underscores our commitment to broadening and enhancing psychiatric care by investing in novel treatment approaches with the potential to reach patients for whom other treatments have been ineffective. We look forward to advancing bretisilocin to late-stage clinical development.”

“AbbVie’s leadership in neuroscience and commitment to advancing innovative treatments make them the ideal partner to advance bretisilocin rapidly forward while enabling Gilgamesh to continue pursuing our broader mission of developing novel, transformative therapies for complex mental health and neurological conditions,” said Jonathan Sporn, M.D., CEO at Gilgamesh Pharmaceuticals.  

Additionally, as part of the transaction, Gilgamesh will spin off a new entity that will operate under the name Gilgamesh Pharma Inc. to hold its employees and other programs, including its oral NMDA receptor antagonist blixeprodil (GM-1020), cardio-safe ibogaine analog, M1/M4 agonist program and existing collaboration with AbbVie. The transaction is subject to customary closing conditions.

This transaction builds upon AbbVie and Gilgamesh’s 2024 collaboration and option-to-license agreement to advance the development of next-generation therapies for the treatment of psychiatric disorders. This option-to-license remains in effect and will be transferred to Gilgamesh Pharma Inc. in connection with the spin-out.