Posted by Michael Wonder on 06 Jan 2026
Alixorexton granted breakthrough therapy designation by US FDA for the treatment of narcolepsy type 1
6 January 2026 - Alkermes today announced that the US FDA has granted breakthrough therapy designation to alixorexton for the treatment of narcolepsy type 1, based on phase 1 and Phase 2 clinical data, including positive results from Vibrance-1, a large (n=92) Phase 2 study evaluating alixorexton in patients with narcolepsy type 1.
Alixorexton is the company’s novel, investigational, oral, selective orexin 2 receptor agonist in development for the treatment of narcolepsy type 1 , narcolepsy type 2 and idiopathic hypersomnia.
