Drug Profile

Reboxetine - Axsome Therapeutics

Alternative Names: AXS 12

Latest Information Update: 25 Feb 2026

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At a glance

Originator Pfizer
Developer Axsome Therapeutics
Class Antidepressants; Ethers; Morpholines; Sleep disorder therapies; Small molecules
Mechanism of Action Adrenergic uptake inhibitors; Dopamine modulators

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Narcolepsy
New Molecular Entity No

Highest Development Phases

Phase III Narcolepsy

Most Recent Events

25 Feb 2026 Reboxetine is still in phase III trials for Narcolepsy in USA and Canada (PO)
23 Feb 2026 Axsome Therapeutics announces intention to complete NDA submission to US FDA for narcolepsy in first quarter of 2026
31 Dec 2025 Axsome therapeutics receives pre-NDA meeting minutes from US FDA for AXS 12 in Narcolepsy

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