Drug research
AXS-12 (reboxetine)
Open a linked trial to see its study details and recorded changes, or check the regulatory events below and follow their sources.
Drug identity checked against registry records
Also recorded as AXS-12; reboxetine
A drug appearing in a clinical trial does not mean it is FDA-approved. Check the original regulatory source for any approval claim.
Included trials
| Trial | Sponsor | Phase | Status | Primary completion |
|---|---|---|---|---|
| A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With NarcolepsyNCT05059223 | AXSM | Phase 3 | Completed | 2024-03-15Actual |
| A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy (ENCORE)NCT05113745 | AXSM | Phase 3 | Completed | 2024-11-15Actual |
Regulatory dates and decisions
| Date as reported | Drug / company | Event | Condition | Evidence |
|---|---|---|---|---|
| 2027-05-01Day | AXS-12 (reboxetine)Axsome Therapeutics, Inc. · AXSM | Company-disclosed PDUFA goal date | cataplexy in narcolepsy | Open original sourceRead source excerptAxsome Therapeutics Announces FDA Acceptance of New Drug Application for AXS-12 for the Treatment of Cataplexy in Narcolepsy FDA sets PDUFA target action date of May 1, 2027 First seen: 25 Sep 2026 · Evidence last checked: 25 Sep 2026 |