Drugs / AXS-05
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Alzheimer disease 5 1 milestone | |||||
| Filed | US (FDA) | — | Alzheimer disease 5 | 2025-11-03 | “Axsome has submitted a supplemental NDA (sNDA) to the FDA for AXS-05 in Alzheimer’s disease agitation.” gcs-web.com ↗ “FDA has accepted for filing the Company’s supplemental New Drug Application (NDA) for AXS-05” gcs-web.com ↗ |
| Filed major depressive disorder 2 milestones | |||||
| Filed | US (FDA) | — | major depressive disorder | 2021-04-26 | “FDA has accepted for filing the Company’s New Drug Application (NDA) for AXS-05 for the treatment of major depressive disorder (MDD)” gcs-web.com ↗ “We successfully filed our NDA for AXS-05 for the treatment of MDD with the FDA” gcs-web.com ↗ |
| Filed | US (FDA) | — | major depressive disorder | 2021-03-01 | “Axsome has submitted a New Drug Application (NDA) to the FDA for AXS-05 for the treatment of MDD.” gcs-web.com ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT04608396 | Aug 2020 → Jul 2021 | major depressive disorder | Axsome Therapeutics, Inc. | Completed | Met primary |
| Phase 2/31 trial · 1 met primary | ||||||
| Phase 2/3 | NCT03226522 | Jul 2017 → Apr 2020 | Alzheimer disease | Axsome Therapeutics, Inc. | Completed | Met primary |
| Phase 35 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT07766655 | Aug 2026 → Dec 2027 expected | — | Axsome Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06736509 | Nov 2024 → Feb 2025 | Alzheimer disease | Axsome Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT05557409 | Sep 2022 → Nov 2024 | Alzheimer disease | Axsome Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04797715 | Dec 2020 → Nov 2022 | Alzheimer disease | Axsome Therapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT02741791 | Mar 2016 → Mar 2020 | major depressive disorder | Axsome Therapeutics, Inc. | Completed | Missed primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT06223880 | Dec 2023 → Mar 2026 overdue | major depressive disorder | Axsome Therapeutics, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 37
| Date | Issuer | Release |
|---|---|---|
| 2026-05-04 | Axsome Therapeutics, Inc. | Regulatory Axsome Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update gcs-web.com ↗
AUVELITY approved for the treatment of agitation associated with dementia due to Alzheimer’s disease |
| 2025-12-31 | Axsome Therapeutics, Inc. | Regulatory Axsome Therapeutics Announces FDA Acceptance and Priority Review of Supplemental New Drug Application for AXS-05 for the Treatment of Alzheimer’s Disease Agitation gcs-web.com ↗
FDA grants AXS-05 Priority Review designation and sets PDUFA action goal date of April 30, 2026 |
| 2025-11-03 | Axsome Therapeutics, Inc. | Regulatory Axsome Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Update gcs-web.com ↗
Our broad development pipeline continues to advance, and we recently submitted our supplemental NDA for AXS-05 for the treatment of Alzheimer’s disease agitation, a serious condition affecting millions of patients in the U.S. , and a critical unmet medical need. |
| 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. |
| 2025-03-03 | Axsome Therapeutics, Inc. | Regulatory Axsome Therapeutics Announces FDA Pre-NDA Meeting Minutes for AXS-05 in Alzheimer’s Disease Agitation Supporting NDA Submission gcs-web.com ↗
today announced that it has received formal pre-New Drug Application (NDA) meeting minutes from the U.S. Food and Drug Administration (FDA) supporting a supplemental NDA (sNDA) submission for AXS-05 in Alzheimer’s disease agitation. |
| 2024-12-30 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces Successful Completion and Results of Phase 3 Clinical Program of AXS-05 in Alzheimer’s Disease Agitation gcs-web.com ↗
ACCORD-2 Phase 3 trial in Alzheimer’s disease agitation achieves primary endpoint compared to placebo (p=0.001, time to relapse) |
| 2024-05-28 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Presents Data from Multiple Programs at the 2024 American Society of Clinical Psychopharmacology Annual (ASCP) Meeting gcs-web.com ↗
Effects of AXS-05 (Dextromethorphan-Bupropion) in Improving Anhedonia and Interest-Activity Symptoms of MDD and the Associated Improvements in Functional Impairment |
| 2023-12-11 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Presents New Data and Post-Hoc Analyses of Auvelity® in Patients with Major Depressive Disorder at the American College of Neuropsychopharmacology (ACNP) 2023 Annual Meeting gcs-web.com ↗
today announced new data that treatment with Auvelity ® (dextromethorphan-bupropion) was associated with improvement in quality of life outcomes in broad populations of depression patients in the EVOLVE open-label trial in major depressive disorder (MDD). |
| 2023-10-24 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Presents Results of the ACCORD trial of AXS-05 in Alzheimer’s Disease Agitation at the Clinical Trials on Alzheimer’s Disease (CTAD) 2023 Conference gcs-web.com ↗
During the placebo-controlled randomized withdrawal phase, AXS-05 statistically significantly delayed the time to relapse of agitation symptoms as compared to placebo. |
| 2023-09-07 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Highlights Commitment to Innovating Treatments for Mental Health Conditions with Presentations at Psych Congress 2023 gcs-web.com ↗
AXS-05 (Dextromethorphan-Bupropion) Significantly Improved Functioning in Major Depressive Disorder: Analysis of the Domains of the Sheehan Disability Scale |
| 2023-05-30 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics to Present Data and Post-Hoc Analyses on Auvelity® and Sunosi® at the 2023 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting gcs-web.com ↗
The presentations on Auvelity incorporate new data and post-hoc analyses including demonstration of functional improvement in patients with major depressive disorder (MDD). |
| 2022-12-07 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Presents New Data from the EVOLVE Open-Label Trial Demonstrating Effects of AUVELITY® on Cognitive and Physical Functioning in Patients with Major Depressive Disorder at the American College of Neuropsychopharmacology (ACNP) 2022 Annua gcs-web.com ↗
In the trial, AUVELITY rapidly, durably, and substantially improved symptoms of depression including cognitive and physical functioning, and reduced disability in patients with MDD who had received one or more prior antidepressants. |
| 2022-11-28 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in the ACCORD Phase 3 Trial in Alzheimer’s Disease Agitation gcs-web.com ↗
AXS-05 statistically significantly delayed time to relapse of Alzheimer’s disease agitation versus placebo (p=0.014, primary endpoint) |
| 2022-08-19 | Axsome Therapeutics, Inc. | Regulatory Axsome Therapeutics Announces FDA Approval of AUVELITY™, the First and Only Oral NMDA Receptor Antagonist for the Treatment of Major Depressive Disorder in Adults gcs-web.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has approved AUVELITY TM (dextromethorphan HBr -bupropion HCl) extended-release tablets for the treatment of major depressive disorder (MDD) in adults. |
| 2022-06-02 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Presents New Data from the GEMINI Trial Demonstrating Efficacy of AXS-05 on Anhedonia in Patients with Major Depressive Disorder gcs-web.com ↗
today announced that treatment with AXS-05 (dextromethorphan-bupropion) rapidly and significantly reduced anhedonic symptoms in the GEMINI Phase 3 trial in major depressive disorder (MDD). |
| 2022-06-01 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces Late-Breaking Presentations of Positive Results of the EVOLVE Trial of AXS-05 in Major Depressive Disorder After Prior Treatment Failures at the American Society of Clinical Psychopharmacology (ASCP) 2022 Annual Meeting gcs-web.com ↗
today announced positive results from the long-term, open-label EVOLVE trial of AXS-05 (dextromethorphan-bupropion) in major depressive disorder (MDD). |
| 2022-05-31 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces Publication of Pivotal GEMINI Phase 3 Trial of AXS-05 in Major Depressive Disorder in The Journal of Clinical Psychiatry gcs-web.com ↗
AXS-05 (dextromethorphan-bupropion) demonstrated rapid, substantial, and statistically significant antidepressant efficacy compared to placebo starting 1 week after treatment |
| 2022-05-18 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces Publication of Pivotal ASCEND Phase 2 Trial of AXS-05 in Major Depressive Disorder in The American Journal of Psychiatry gcs-web.com ↗
today announced the publication of the results from the pivotal ASCEND Phase 2 clinical trial of AXS-05 (dextromethorphan-bupropion) in major depressive disorder (MDD). |
| 2021-08-23 | Axsome Therapeutics, Inc. | Regulatory Axsome Therapeutics Provides Update on the New Drug Application for AXS-05 for the Treatment of Major Depressive Disorder gcs-web.com ↗
The FDA did not request additional information from the Company, and the review of the application is ongoing. |
| 2021-08-09 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces AXS-05 Achieves Primary and Key Secondary Endpoints in the MERIT Phase 2 Trial in Treatment Resistant Depression gcs-web.com ↗ |
| 2021-04-26 | Axsome Therapeutics, Inc. | Regulatory Axsome Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for AXS-05 for Treatment of Major Depressive Disorder gcs-web.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s New Drug Application (NDA) for AXS-05 for the treatment of major depressive disorder (MDD), and has granted the application Priority Review. |
| 2020-12-08 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces Positive Results from the COMET-SI Trial of AXS-05 in Patients with Major Depressive Disorder Who Have Suicidal Ideation gcs-web.com ↗ |
| 2020-12-02 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces Positive Results from the COMET-TRD Trial of AXS-05 in Patients with Treatment Resistant Depression 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 positive results from the open-label Phase 2 COMET-TRD trial of AXS-05 in patients with treatment resistant depression (TRD). |
| 2020-12-01 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces Positive Efficacy and Safety Results from Phase 3 COMET Long-Term Trial and COMET-AU Trial of AXS-05 in Major Depressive Disorder gcs-web.com ↗
Patients treated with AXS-05 in these trials experienced rapid, substantial, and durable improvements in depressive symptoms and functional impairment that was sustained over the 12-month treatment period. |
| 2020-09-14 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Presents New Data from GEMINI Phase 3 Trial with AXS-05 Demonstrating Rapid and Significant Improvements in Patient-Reported Outcomes in Major Depressive Disorder gcs-web.com ↗
today announced that AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity, rapidly and significantly improved patient-reported outcomes of depression in patients with major depressive disorder (MDD) in the GEMINI Phase 3 trial. |
| 2020-06-26 | Axsome Therapeutics, Inc. | Regulatory Axsome Therapeutics Receives FDA Breakthrough Therapy Designation for AXS-05 for the Treatment of Alzheimer’s Disease Agitation gcs-web.com ↗ |
| 2020-04-27 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in the ADVANCE-1 Pivotal Phase 2/3 Trial in Alzheimer’s Disease Agitation 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, today announced that AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity, met the primary endpoint in the ADVANCE-1 Phase 2/3 trial and rapidly, substantially, and significantly improved agitation in patients with Alzheimer’s disease as compared to placebo. |
| 2020-03-30 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces Topline Results of the STRIDE-1 Phase 3 Trial in Treatment Resistant Depression and Expert Call to Discuss Clinical Implications gcs-web.com ↗
AXS-05 rapidly and significantly improved symptoms in patients with TRD as measured by MADRS averaged over the entire 6-week treatment period, a key secondary endpoint, with mean reductions of 8.6 for AXS-05 versus 6.7 for bupropion (p=0.031). |
| 2019-12-16 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in GEMINI Phase 3 Trial in Major Depressive Disorder gcs-web.com ↗ |
| 2019-05-06 | Axsome Therapeutics, Inc. | Regulatory Axsome Therapeutics Announces Expedited Development and Pivotal Status for AXS-05 in the Treatment of Major Depressive Disorder based on FDA Breakthrough Therapy Meeting 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, today announced that the development status and plan for AXS-05 in the treatment of major depressive disorder (MDD) and treatment resistant depression (TRD) have been expedited following a Breakthrough Therapy meeting with the U.S. Food and Drug Administration ( FDA ). |
| 2019-04-15 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in Phase 2 Trial in Smoking Cessation gcs-web.com ↗
The analysis showed that AXS-05 met the prespecified primary endpoint and significantly reduced daily smoking as compared to the active comparator bupropion. |
| 2019-03-27 | Axsome Therapeutics, Inc. | Regulatory Axsome Therapeutics Receives FDA Breakthrough Therapy Designation for AXS-05 for the Treatment of Major Depressive Disorder 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, today announced that the U.S. Food and Drug Administration ( FDA ) has granted Breakthrough Therapy designation for AXS-05 for the treatment of major depressive disorder (MDD). |
| 2019-01-07 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in Phase 2 Trial in Major Depressive Disorder gcs-web.com ↗
today announced that AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity, met the prespecified primary endpoint and significantly improved symptoms of depression in the ASCEND Phase 2 trial in major depressive disorder (MDD). |
| 2018-12-10 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces Positive Outcome of Interim Analysis of ADVANCE-1 Phase 2/3 Trial of AXS-05 in Alzheimer’s Disease Agitation gcs-web.com ↗
Based on the results of the analysis, the IDMC recommended continuation of the AXS-05 treatment arm. |
| 2018-04-26 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Announces Positive Outcome of Interim Analysis of STRIDE-1 Phase 3 Trial of AXS-05 in Treatment Resistant Depression gcs-web.com ↗
Based on the results of the analysis, the IDMC recommended that the trial continue. |
| 2018-03-12 | Axsome Therapeutics, Inc. | Results Axsome Therapeutics Presents Scientific Rationale for the Development of AXS-05 at the 20th Annual Meeting of the American Society for Experimental Neurotherapeutics gcs-web.com ↗
Pharmacokinetic data with AXS-05 and clinical observations with dextromethorphan indicate that AXS-05 increases dextromethorphan concentrations into a potentially therapeutic range. |
| 2017-05-08 | Axsome Therapeutics, Inc. | Regulatory Axsome Therapeutics Receives FDA Fast Track Designation for AXS-05 for Alzheimer’s Disease Agitation gcs-web.com ↗
received Fast Track designation from the U.S. Food and Drug Administration ( FDA ) for AXS-05 for the treatment of agitation in patients with Alzheimer’s disease (AD). |
All press releases naming this drug 63 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AXS-05 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04797715 ↗ |
| Known as | dextromethorphan-bupropion | “Experimental: AXS-05 (dextromethorphan-bupropion) up to 25 weeks” NCT06736509 ↗ |
| Route | Oral | “AXS-05 Administered Orally” NCT02741791 ↗ |