AXS-12 (reboxetine) is a highly selective and potent norepinephrine reuptake inhibitor being developed for the treatment of narcolepsy. It modulates noradrenergic activity to promote wakefulness, maintain muscle tone and enhance cognition.
Reboxetine has an extensive safety record in Europe and in over 40 countries where it’s approved for the treatment of depression.
In narcolepsy, AXS-12 is supported by positive pre-clinical and Phase 2 clinical results where it:
- Improved daytime sleepiness with reduced cataplexy (sudden loss of muscle control) in people with narcolepsy in an open-label pilot trial
AXS-12 is an investigational drug product not approved by the FDA.
clinical and regulatory
AXS-12 has been granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation and Orphan Drug designation for the treatment of narcolepsy.