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Also known as AXS-14 (esreboxetine)
AXS-14 · 2 trials · 1 indication
Incidence of treatment-emergent adverse events following dosing with AXS-14
| Arm | Type | Description |
|---|---|---|
| AXS-14 (esreboxetine) | EXPERIMENTAL | Up to 52 weeks. |
| Placebo | PLACEBO_COMPARATOR | • Up to 12 weeks in the randomized double-blind period (if applicable) |
| Name | Type | Description |
|---|---|---|
| AXS-14 (esreboxetine) | DRUG | AXS-14 tablets taken twice daily. |
| Placebo | DRUG | Placebo tablets taken once daily |
Inclusion Criteria: * Participation in AXS-14-FM-301. Exclusion Criteria: * Unable to comply with study procedures. * Medically inappropriate for study participation in the opinion of the Investigator.
Top 1 of 2 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Axsome Therapeutics, Inc. | AXSM | 2 | PHASE3 | AXS-14 |
AXS-14 is an investigational small molecule being developed for the treatment of fibromyalgia. It is currently in Phase 3 clinical development and has not been approved by the FDA. Two Phase 3 trials are evaluating its safety and efficacy in patients with fibromyalgia.
AXS-14 targets the norepinephrine transporter. By inhibiting this transporter, it is thought to increase norepinephrine levels in the brain, which may help modulate pain pathways involved in fibromyalgia. This mechanism is being studied in Phase 3 clinical trials.
AXS-14 is being developed by Axsome Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker AXSM. The company is conducting Phase 3 clinical trials to evaluate AXS-14 for the treatment of fibromyalgia.
AXS-14 is in Phase 3 clinical development for fibromyalgia. It is an investigational drug and has not received FDA approval. Two Phase 3 trials are currently ongoing, one recruiting participants and one enrolling by invitation.
AXS-14 is being studied in two Phase 3 trials for fibromyalgia. NCT07398417 is a randomized withdrawal study with 620 participants, and NCT07637162 is an open-label safety study with 300 participants. Both trials are being conducted in the United States.
Yes, AXS-14 is also known as esreboxetine. The drug is being developed under the name AXS-14, with esreboxetine as its nonproprietary name. Clinical trials for fibromyalgia refer to the drug as AXS-14 (esreboxetine).