Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07398417 | Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design | PHASE3 | RECRUITING | 620 | — | — | Jan 14, 2026 | Mar 1, 2028 | Feb 9, 2026 | 16 | United States |
| Arm | Type | Description |
|---|---|---|
| AXS-14 (esreboxetine) | EXPERIMENTAL | * Up to 12 weeks in the open-label period; * Up to 12 weeks in the randomized double-blind period (if applicable) |
| 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 once daily |
| Placebo | DRUG | Placebo tablets taken once daily |
Inclusion Criteria: * Has a primary diagnosis of fibromyalgia based on the 2016 ACR diagnostic criteria. * Male or female, ≥18 years of age. * Provides written informed consent to participate in the study before conducting any study procedures. Exclusion Criteria: * Previous participation in a cl...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Axsome Therapeutics, Inc. | AXSM | 1 | PHASE3 | AXS-14 |
| Grace Therapeutics, Inc. | GRCE | 1 | — | Undisclosed |