Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 an investigational small molecule being developed for the treatment of narcolepsy, including cataplexy and excessive daytime sleepiness. It is being studied in patients aged 15 years and older. AXS-12 has received orphan drug designation from the FDA for this condition.
AXS-12 is a small molecule that targets the norepinephrine transporter. By inhibiting this transporter, it is believed to increase norepinephrine levels in the brain, which may help regulate sleep-wake cycles and reduce cataplexy episodes in patients with narcolepsy.
AXS-12 is being developed by Axsome Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AXSM. The company is conducting clinical trials to evaluate the efficacy and safety of AXS-12 in patients with narcolepsy.
AXS-12 is currently in Phase 3 clinical development for narcolepsy. It has completed three clinical trials, including two Phase 3 studies and one Phase 2 study. AXS-12 is investigational and has not been approved by the FDA for any use.
AXS-12 has been studied in three completed clinical trials. The Phase 2 CONCERT trial (NCT03881852) enrolled 21 patients, while the Phase 3 trials NCT05059223 and NCT05113745 enrolled 90 and 68 patients, respectively. All trials evaluated AXS-12 in patients with narcolepsy and cataplexy.
Yes, AXS-12 is also known as reboxetine. Clinical trials for AXS-12 use the name reboxetine in their titles, such as the CONCERT study. Reboxetine is a selective norepinephrine reuptake inhibitor being repurposed for the treatment of narcolepsy.