Safety, tolerability, and efficacy of alixorexton, a selective orexin 2 receptor agonist for narcolepsy type 1 (Vibrance-1): a randomised, double-blind, placebo-controlled, phase 2 trial.

In 30 seconds

This phase 2 randomized, double-blind, placebo-controlled trial evaluated the safety, tolerability, and efficacy of alixorexton, an orexin 2 receptor agonist, in 92 adults with narcolepsy type 1. At week 6, alixorexton significantly improved mean sleep latency on the Maintenance of Wakefulness Test, with a placebo-corrected change of 26.0 minutes for the 8 mg dose.

Key findings

• Alixorexton 8 mg improved mean sleep latency by 26.0 minutes compared to placebo.
• The treatment was well tolerated, with adverse events like pollakiuria occurring in 55% of participants.
• Significant improvements were observed in wakefulness and excessive daytime sleepiness.
• Adverse events were consistent with known effects of OX2R agonists.

Why it matters

The findings suggest that alixorexton may offer a new therapeutic option for improving wakefulness and managing symptoms in patients with narcolepsy type 1, addressing a significant unmet need in this population.