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MAY 1 2027
UPCOMING · 274 DAYS TO PDUFA

Axsome Therapeutics reboxetine $AXSM

for cataplexy in narcolepsy

NDA · Standard Review

Accepted JUL 15 2026.

About

Narcolepsy is a chronic neurological disorder characterized by excessive daytime sleepiness and sudden, brief episodes of muscle weakness or paralysis triggered by strong emotions, known as cataplexy. AXS-12 is an oral drug that works by selectively increasing levels of norepinephrine and modulating dopamine in the brain. By boosting these key signaling chemicals, it may help stabilize muscle control to reduce the frequency of cataplexy attacks.

Pivotal trial

NCT05113745 Phase 3 completed NCT05113745

This study will evaluate the long-term efficacy and safety of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).

Source: ClinicalTrials.gov

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