AXS-12 Phase 3 Trial Enrolls First Individual

Axsome Therapeutics continues to explore its narcolepsy drug after the FDA granted it orphan drug designation.

Axsome Therapeutics, Inc, has enrolled its first individual in the Study Evaluating a Mechanistic Approach to Treating Narcolepsy (SYMPHONY) of its new oral norepinephrine reuptake inhibitor, AXS-12.

“The advancement of AXS-12 into phase 3 testing for narcolepsy demonstrates Axsome’s commitment to developing important new medicines for patients living with serious CNS conditions,” Herriot Tabuteau, MD, chief executive officer of Axsome, said in a statement.

“Narcolepsy impairs almost every aspect of a patient’s life, including cognitive, psychological, social, and emotional functioning. If successfully developed, AXS-12 may address multiple symptoms of this debilitating condition,” Tabuteau said.

SYMPHONY is a double-blind, placebo-controlled, randomized trial with individuals who have narcolepsy.

The FDA has granted AXS-12 orphan drug designation to treat narcolepsy.

Top-line results from the study are expected in the first half of 2023.


Axsome Therapeutics initiates SYMPHONY Phase 3 Trails of AXS-12 in Narcolepsy. Yahoo! Finance. News release. September 16, 2021. Accessed September 24, 2021.