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Also known as AXS-14 (esreboxetine), 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.
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Axsome Therapeutics, Inc. | AXSM | 1 | PHASE3 | AXS-14 |
| Grace Therapeutics, Inc. | GRCE | 1 | - | Undisclosed |
AXS-14 is an investigational small molecule being developed for the treatment of fibromyalgia, a chronic musculoskeletal condition characterized by widespread pain. It is currently in Phase 3 clinical development and has not been approved by the FDA.
AXS-14 is a small molecule, but its specific molecular target has not been disclosed in available information. The drug is being studied for its potential to treat fibromyalgia, though the exact mechanism of action is not specified.
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 the drug for fibromyalgia.
AXS-14 is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 3 trials are currently ongoing, including a randomized withdrawal study and an open-label safety study.
AXS-14 is being evaluated in two Phase 3 trials. NCT07398417 is a randomized, double-blind, placebo-controlled withdrawal study with 620 participants, and NCT07637162 is an open-label safety study with 300 participants. Both are enrolling in the United States.
Yes, AXS-14 is also known as esreboxetine. The drug is referred to by both names in clinical trial documentation, and both names refer to the same investigational compound being developed for fibromyalgia.