Alkermes Introduces Alixorexton for the Treatment of Narcolepsy Type 1
Alkermes has introduced alixorexton for the treatment of narcolepsy type 1 (NT1), a chronic neurological disorder characterised by excessive daytime sleepiness and disrupted regulation of wakefulness.
Alixorexton is an investigational oral therapy designed to selectively activate the orexin 2 receptor (OX2R), a key pathway involved in maintaining wakefulness. The therapy is being developed for the treatment of narcolepsy type 1, narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH).
The designation is supported by Phase 1 and Phase 2 clinical data, including results from the Vibrance-1 Phase 2 study involving patients with narcolepsy type 1. The study met its primary endpoint across all tested dose levels, demonstrating statistically significant and clinically meaningful improvements in wakefulness compared with placebo. Alixorexton was generally well tolerated throughout the trial.
A global Phase 3 clinical programme for alixorexton in narcolepsy is planned to begin during the first quarter of 2026. The therapy is also being evaluated in additional sleep disorders, including narcolepsy type 2 and idiopathic hypersomnia.
Narcolepsy type 1 is a rare chronic neurological disorder characterised by excessive daytime sleepiness, sudden episodes of muscle weakness known as cataplexy, disrupted nighttime sleep and other symptoms that can significantly affect daily life.
Orexin is a neuropeptide produced in the hypothalamus and plays a central role in regulating wakefulness through multiple pathways in the brain. Targeting the orexin system may help address excessive daytime sleepiness across a range of hypersomnolence disorders, regardless of the underlying cause of the condition.
Alixorexton, previously known as ALKS 2680, has been evaluated in Phase 1 studies involving healthy volunteers and patients with NT1, NT2 and IH, as well as in the Vibrance-1 and Vibrance-2 Phase 2 studies. The therapy is currently being investigated in the Phase 2 Vibrance-3 study in patients with idiopathic hypersomnia.
