Approval Probability
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Adjusted LOA
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Also known as AXS-12 (Reboxetine)
AXS-12 · 3 trials · 5 indications
Average number of cataplexy attacks per week
Presented as LSmeans. A positive change is indicative of improvement.
| Arm | Type | Description |
|---|---|---|
| AXS-12 (reboxetine) | EXPERIMENTAL | * Up to 24 weeks in open-label period * Up to 4 weeks in randomized double-blind period |
| Placebo | PLACEBO_COMPARATOR | Up to 4 weeks in randomized double-blind period |
| Name | Type | Description |
|---|---|---|
| AXS-12 (reboxetine) | DRUG | AXS-12 tablets, taken twice daily |
| Placebo | DRUG | Placebo tablets, taken twice daily |
Inclusion Criteria: * Completed the treatment period of Study AXS-12-301 * Willing and able to comply with the study requirements Exclusion Criteria: * Significant change in medical history or concomitant medications since enrolling in the AXS-12-301 study which, in the opinion of the Investigato...
AXS-12 is being developed for the treatment of narcolepsy, including symptoms such as cataplexy and excessive daytime sleepiness. It is an investigational small molecule therapy that has completed Phase 3 clinical trials and is currently under review by the FDA, with an orphan drug designation for narcolepsy.
AXS-12 is being developed by Axsome Therapeutics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol AXSM. Axsome is responsible for the clinical development and regulatory submission of AXS-12 for narcolepsy.
AXS-12 has completed Phase 3 clinical development and is currently in the NDA/BLA regulatory review phase. The program includes three completed trials: two Phase 3 studies and one Phase 2 study, with a total of 179 participants enrolled across all trials.
AXS-12 has been evaluated in three completed clinical trials: the Phase 3 ENCORE study (NCT05113745), the Phase 3 study NCT05059223, and the Phase 2 CONCERT study (NCT03881852). All trials enrolled patients with narcolepsy and related symptoms such as cataplexy and excessive daytime sleepiness.
Yes, AXS-12 is also known as reboxetine. AXS-12 (reboxetine) is the investigational formulation being developed by Axsome Therapeutics for narcolepsy. The alternative names AXS-12 (Reboxetine) and AXS-12 (reboxetine) refer to the same drug candidate.
Yes, AXS-12 has received orphan drug designation from the FDA for the treatment of narcolepsy. This designation is granted to drugs intended for rare diseases or conditions, and it provides certain regulatory incentives to the developer, Axsome Therapeutics.