Drugs / AXS-12
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | narcolepsy 1 | 2026-05-04 | “the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s New Drug Application (NDA) for AXS-12” gcs-web.com ↗ “NDA for AXS-12 for the treatment of cataplexy in narcolepsy submitted to the FDA” gcs-web.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT03881852 | Apr → Nov 2019 | hypersomnia, narcolepsy-cataplexy syndrome | Axsome Therapeutics, Inc. | Completed | Met primary |
| Phase 32 trials | ||||||
| Phase 3 | NCT05113745 | Oct 2021 → Nov 2024 | narcolepsy-cataplexy syndrome | Axsome Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT05059223 | Sep 2021 → Mar 2024 | narcolepsy-cataplexy syndrome | Axsome Therapeutics, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-07-15 | Axsome Therapeutics, Inc. | Regulatory Axsome Therapeutics Announces FDA Acceptance of New Drug Application for AXS-12 for the Treatment of Cataplexy in Narcolepsy 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 that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s New Drug Application (NDA) for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy. |
| 2025-04-04 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Presents Positive Pivotal Phase 3 Results of the ACCORD-2 Trial of AXS-05 in Alzheimer’s Disease Agitation and the SYMPHONY Trial of AXS-12 in Narcolepsy at the 2025 American Academy of Neurology (AAN) Annual Meeting gcs-web.com ↗
Oral and poster presentations include data from the positive pivotal ACCORD-2 Phase 3 trial of AXS-05 in Alzheimer’s disease (AD) agitation, accepted as a late-breaking abstract, and from the positive pivotal SYMPHONY Phase 3 trial of AXS-12 in narcolepsy. |
| 2024-11-26 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces AXS-12 Achieves Primary Endpoint in ENCORE Long-Term Phase 3 Trial in Narcolepsy gcs-web.com ↗ |
| 2024-03-25 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces AXS-12 Achieves Primary Endpoint in the SYMPHONY Phase 3 Trial in Narcolepsy gcs-web.com ↗
today announced that AXS-12 (reboxetine), a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator, achieved the primary endpoint and significantly reduced the frequency of cataplexy attacks as compared to placebo in patients with narcolepsy in the SYMPHONY Phase 3 trial. |
| 2020-09-21 | Axsome Therapeutics, Inc. | Regulatory Axsome Therapeutics Announces Expedited Development of AXS-12 for the Treatment of Narcolepsy Based on FDA Breakthrough Therapy Meeting gcs-web.com ↗
Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that the development plan for AXS-12 for the treatment of narcolepsy has been expedited following a Breakthrough Therapy meeting with the U.S. Food and Drug Administration (FDA). |
| 2020-08-05 | Axsome Therapeutics, Inc. | Regulatory Axsome Therapeutics Receives FDA Breakthrough Therapy Designation for AXS-12 for the Treatment of Narcolepsy gcs-web.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for AXS-12 for the treatment of cataplexy in patients with narcolepsy. |
| 2019-12-03 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces AXS-12 Achieves Primary Endpoint in CONCERT Phase 2 Trial in Narcolepsy gcs-web.com ↗
today announced that AXS-12 (reboxetine) met the prespecified primary endpoint and significantly reduced the number of cataplexy attacks as compared to placebo in patients with narcolepsy in the CONCERT Phase 2 trial. |
| 2018-12-27 | Axsome Therapeutics, Inc. | Regulatory Axsome Therapeutics Provides Year End 2018 Clinical Update gcs-web.com ↗
FDA clearance of IND received for Phase 2 trial of AXS-12 in narcolepsy |
| 2018-10-17 | Axsome Therapeutics, Inc. | Regulatory Axsome Therapeutics Receives FDA Orphan Drug Designation for AXS-12 for the Treatment of Narcolepsy gcs-web.com ↗
Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, received on Tuesday, October 16 , Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for AXS-12 for the treatment of narcolepsy. |
All press releases naming this drug 20 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AXS-12 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05113745 ↗ |
| Known as | reboxetine | “AXS-12 (reboxetine)” NCT05059223 ↗ |
| Route | Oral | “Dosed orally” NCT03881852 ↗ |