Drugs / AXS-14
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Rejected (CRL) | US (FDA) | — | fibromyalgia | 2025-06-09 | “Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for AXS-14 (esreboxetine) for the management of fibromyalgia” gcs-web.com ↗ |
| Filed | US (FDA) | — | fibromyalgia | 2025-05-05 | “NDA for AXS-14 for the management of fibromyalgia submitted to the FDA” gcs-web.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT07637162 | Apr 2026 → May 2028 expected | fibromyalgia | Axsome Therapeutics, Inc. | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT07398417 | Jan 2026 → Mar 2028 expected | fibromyalgia | Axsome Therapeutics, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2025-06-09 | Axsome Therapeutics, Inc. | Regulatory Axsome Therapeutics Provides Update on the New Drug Application (NDA) for AXS-14 for the Management of Fibromyalgia gcs-web.com ↗
Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced it has received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for AXS-14 (esreboxetine) for the management of fibromyalgia. |
| 2020-01-13 | Pfizer | Results Axsome Therapeutics Enters into Exclusive License Agreement with Pfizer Inc. for Pfizer’s Reboxetine Clinical and Nonclinical Data and for New Phase 3 Esreboxetine Product Candidate pfizer.com ↗
Esreboxetine met primary endpoints in completed Pfizer Phase 3 and Phase 2 placebo-controlled clinical trials in fibromyalgia (p<0.001, and p<0.001) |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-01-15 | Axsome Therapeutics, Inc. | Axsome Therapeutics Initiates FORWARD Phase 3 Trial of AXS-14 for the Management of Fibromyalgia gcs-web.com ↗ |
| 2025-06-09 | Axsome Therapeutics, Inc. | Axsome Therapeutics Provides Update on the New Drug Application (NDA) for AXS-14 for the Management of Fibromyalgia gcs-web.com ↗ |
| 2021-06-15 | Axsome Therapeutics, Inc. | Axsome Therapeutics Announces Planned NDA Submission for AXS-14 for the Management of Fibromyalgia gcs-web.com ↗ |
| 2020-01-13 | Pfizer | Axsome Therapeutics Enters into Exclusive License Agreement with Pfizer Inc. for Pfizer’s Reboxetine Clinical and Nonclinical Data and for New Phase 3 Esreboxetine Product Candidate pfizer.com ↗ |
| 2020-01-13 | Axsome Therapeutics, Inc. | Axsome Therapeutics Enters into Exclusive License Agreement with Pfizer Inc. for Pfizer’s Reboxetine Clinical and Nonclinical Data and for New Phase 3 Esreboxetine Product Candidate gcs-web.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AXS-14 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07398417 ↗ |
| Known as | Esreboxetine | “Drug: AXS-14 (Esreboxetine)” NCT07398417 ↗1“AXS-14 (esreboxetine)” NCT07637162 ↗ |
| Route | Oral | “AXS-14 tablets taken once daily” NCT07398417 ↗ |