Phase 2 trial finds orexin agonist alixorexton improves wakefulness in narcolepsy

This randomised, double-blind, placebo-controlled phase 2 trial (Vibrance-1) evaluated the oral OX2R agonist alixorexton in adults with narcolepsy type 1 across three doses versus placebo over 6 weeks. The trial reported significant placebo-corrected improvements in mean sleep latency on the Maintenance of Wakefulness Test at all doses, with treatment-emergent adverse events including pollakiuria, insomnia, and salivary hypersecretion occurring more often than with placebo. The authors state these findings support further phase 3 evaluation of alixorexton, funded by Alkermes.

Most relevant for: Adults diagnosed with narcolepsy type 1 confirmed by polysomnography, Multiple Sleep Latency Test, or cerebrospinal hypocretin-1 testing.

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