COMPANY
Axsome Therapeutics
FDA-approved therapeutic company Clinical Phase 3
Axsome focuses on central nervous system (CNS) conditions including depression, Alzheimer's disease agitation, migraine, narcolepsy and fibromyalgia. From company website Source · Oct 12, 2026
Hiring
| Title | Location (from posting) | Employer posted | First seen |
|---|---|---|---|
| Manager, Sales Training and Development | New York, NY | Oct 22, 2026 | Oct 23, 2026 |
| Medical Writer/Senior Medical Writer | New York, NY | Oct 22, 2026 | Oct 23, 2026 |
| Manager/Senior Manager, Market Research | New York, NY | Oct 22, 2026 | Oct 23, 2026 |
| Specialty Account Manager, Long Term Care (Kansas City, MO) | Kansas City, MO | Oct 21, 2026 | Oct 22, 2026 |
| Specialty Account Manager, Long Term Care (Omaha, NE) | Omaha, NE | Oct 21, 2026 | Oct 22, 2026 |
Trial and FDA signals
- New trial + clinical hiring Started a Phase 3 trial (NCT07766655, actual start Aug 27, 2026) (+1 other new trial); since then posted 3 clinical-operations roles. ClinicalTrials.gov NCT07766655 (Aug 27, 2026)
Evidence (2 events)
- Aug 27, 2026 · ClinicalTrials.gov NCT07766655
leadSponsor.name='Axsome Therapeutics, Inc.'; phases=['PHASE3']; overallStatus=RECRUITING; startDateStruct={date:2026-08-27,type:ACTUAL}; studyFirstPostDate=2026-08-14; briefTitle='Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)' - Aug 6, 2026 · ClinicalTrials.gov NCT07773883
leadSponsor.name='Axsome Therapeutics, Inc.'; phases=['PHASE3']; overallStatus=ENROLLING_BY_INVITATION; startDateStruct={date:2026-08-06,type:ACTUAL}; studyFirstPostDate=2026-08-19; briefTitle='An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD'
- Aug 27, 2026 · ClinicalTrials.gov NCT07766655
Timeline
- Board tracked Radar started tracking this company’s job board (117 open jobs at last check). source ↗
- Trial start Phase 3: Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT) source ↗
- Trial start Phase 3: An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD source ↗
- Trial start Phase 3: Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2) source ↗
- Trial start Phase 3: Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-3) source ↗
- FDA FDA New indication / efficacy supplement: AUVELITY (bupropion hydrochloride; dextromethorphan hydrobromide) — NDA215430/18, Apr 30, 2026. Applicant at approval: Axsome Therapeutics, Inc. source ↗
- Trial start Phase 3: Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia source ↗
- Trial start Phase 3: Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol source ↗
- Trial start Phase 3: Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design source ↗
- Debt Debt: $570M (not counted as a raise), announced May 13, 2025. Source: SEC filing. source ↗
- Trial start Phase 3: A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder source ↗
- FDA FDA Original approval: SYMBRAVO (meloxicam; rizatriptan benzoate) — NDA215431, Jan 30, 2025. Applicant at approval: Axsome Therapeutics, Inc. source ↗
- Trial start Phase 3: An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study source ↗
- Trial start Phase 3: Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN) source ↗
- Trial start Phase 3: Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol source ↗
- Trial start Phase 3: Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol source ↗
- Trial start Phase 4: A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms source ↗
- Trial start Phase 3: A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS) source ↗
- Trial start Phase 3: A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation source ↗
- Trial start Phase 3: Open-Label Study of AXS-07 for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor (EMERGE) source ↗
- Trial start Phase 3: A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy (ENCORE) source ↗
- Trial start Phase 3: A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy source ↗
- Trial start Phase 1: Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration source ↗
- Trial start Phase 3: A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation source ↗
- Trial start Phase 4: Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study source ↗
Upcoming milestones
- 2026-12 (ESTIMATED) · Phase 3 · Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol · NCT06413433
- 2026-12 (ESTIMATED) · Phase 3 · Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN) · NCT06568367
- 2027-12 (ESTIMATED) · Phase 3 · Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT) · NCT07766655
- 2027-12 (ESTIMATED) · Phase 3 · An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD · NCT07773883
- 2027-12 (ESTIMATED) · Phase 3 · A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder · NCT06878976
- 2028-03 (ESTIMATED) · Phase 3 · Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design · NCT07398417
- 2028-05 (ESTIMATED) · Phase 3 · Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia · NCT07637162
- Jun 30, 2028 (ESTIMATED) · Phase 3 · Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2) · NCT07717879
Open jobs 117
Funding
- Debt: $570M (not counted as a raise), announced May 13, 2025. Source: SEC filing. source ↗
Clinical trials (lead sponsor) 37
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT06413420 | SUNOSI® (Solriamfetol) Pregnancy Registry | Not listed | Recruiting | Jul 31, 2019 | 2029-09 (estimated) |
| NCT07717879 | Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2) | Phase 3 | Recruiting | Jul 6, 2026 | Jun 30, 2028 (estimated) |
| NCT07766655 | Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT) | Phase 3 | Recruiting | Aug 27, 2026 | 2027-12 (estimated) |
| NCT07773883 | An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD | Phase 3 | Enrolling by invitation | Aug 6, 2026 | 2027-12 (estimated) |
| NCT07717892 | Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-3) | Phase 3 | Recruiting | Jun 25, 2026 | Jun 30, 2028 (estimated) |
| NCT07637162 | Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia | Phase 3 | Enrolling by invitation | Apr 29, 2026 | 2028-05 (estimated) |
| NCT07398417 | Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design | Phase 3 | Recruiting | Jan 14, 2026 | 2028-03 (estimated) |
| NCT05557409 | A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation | Phase 3 | Completed | Sep 6, 2022 | Nov 21, 2024 (actual) |
| NCT06878976 | A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder | Phase 3 | Enrolling by invitation | Feb 20, 2025 | 2027-12 (estimated) |
| NCT06413433 | Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol | Phase 3 | Recruiting | Apr 26, 2024 | 2026-12 (estimated) |
| NCT06568367 | Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN) | Phase 3 | Recruiting | Aug 1, 2024 | 2026-12 (estimated) |
| NCT07484217 | Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol | Phase 3 | Recruiting | Feb 23, 2026 | 2028-12 (estimated) |
| NCT06736509 | An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study | Phase 3 | Terminated | Nov 21, 2024 | Feb 17, 2025 (actual) |
| NCT03881852 | Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT) | Phase 2 | Completed | Apr 5, 2019 | Nov 27, 2019 (actual) |
| NCT05059223 | A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy | Phase 3 | Completed | Sep 15, 2021 | Mar 15, 2024 (actual) |
| NCT05972044 | A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS) | Phase 3 | Completed | Jul 6, 2023 | Feb 7, 2025 (actual) |
| NCT04634669 | Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE) | Phase 2 | Terminated | Sep 23, 2020 | Feb 18, 2022 (actual) |
| NCT04163185 | Initiating Early Control of Migraine Pain and Associated Symptoms | Phase 3 | Completed | Oct 8, 2019 | Mar 16, 2020 (actual) |
| NCT04789174 | Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study | Phase 4 | Completed | May 17, 2021 | Sep 19, 2022 (actual) |
| NCT06360419 | Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol | Phase 3 | Completed | Mar 18, 2024 | Dec 31, 2024 (actual) |
| NCT04947553 | A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation | Phase 3 | Completed | Jun 17, 2021 | Dec 3, 2024 (actual) |
| NCT05550207 | Open-Label Study of AXS-07 for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor (EMERGE) | Phase 3 | Completed | Aug 31, 2022 | Nov 27, 2024 (actual) |
| NCT05113745 | A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy (ENCORE) | Phase 3 | Completed | Oct 20, 2021 | Nov 15, 2024 (actual) |
| NCT06223880 | A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms | Phase 4 | Recruiting | Dec 27, 2023 | 2026-03 (estimated) |
| NCT04797715 | Assessing Clinical Outcomes in Alzheimer's Disease Agitation | Phase 3 | Completed | Dec 31, 2020 | Nov 21, 2022 (actual) |
| NCT04068051 | Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT) | Phase 3 | Completed | Jul 6, 2019 | Sep 22, 2020 (actual) |
| NCT03226522 | Addressing Dementia Via Agitation-Centered Evaluation | Phase 2/Phase 3 | Completed | Jul 13, 2017 | Apr 17, 2020 (actual) |
| NCT03896009 | Maximizing Outcomes in Treating Acute Migraine | Phase 3 | Completed | Mar 4, 2019 | Dec 10, 2019 (actual) |
| NCT05008341 | Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration | Phase 1 | Completed | Aug 27, 2021 | Apr 15, 2022 (actual) |
| NCT04019704 | A Trial of AXS-05 in Patients With Major Depressive Disorder | Phase 3 | Completed | Jun 20, 2019 | Nov 26, 2019 (actual) |
| NCT04039022 | Open-Label Safety Study of AXS-05 in Subjects With Depression | Phase 3 | Completed | Jul 8, 2019 | Oct 23, 2020 (actual) |
| NCT04608396 | Mechanistic Evaluation of Response in TRD (MERIT) | Phase 2 | Completed | Aug 13, 2020 | Jul 30, 2021 (actual) |
| NCT03595579 | Assessing Symptomatic Clinical Episodes in Depression | Phase 2 | Completed | May 30, 2018 | Jan 7, 2019 (actual) |
| NCT04971291 | An Evaluation of AXS-05 for the Treatment of TRD in Treatment-Adherent Patients | Phase 2 | Unknown status (ClinicalTrials.gov) | Apr 14, 2021 | 2021-07 (estimated) |
| NCT02741791 | A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder | Phase 3 | Completed | 2016-03 | Mar 20, 2020 (actual) |
| NCT02746068 | A Study to Assess the Efficacy and Safety of AXS-02 in Subjects With Knee OA Associated With Bone Marrow Lesions | Phase 3 | Unknown status (ClinicalTrials.gov) | 2016-03 | 2020-12 (estimated) |
| NCT02504008 | CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1 | Phase 3 | Unknown status (ClinicalTrials.gov) | 2015-07 | 2019-01 (estimated) |
FDA records (last 2 years)
- FDA New indication / efficacy supplement: AUVELITY (bupropion hydrochloride; dextromethorphan hydrobromide) — NDA215430/18, Apr 30, 2026. Applicant at approval: Axsome Therapeutics, Inc. source ↗
- FDA Original approval: SYMBRAVO (meloxicam; rizatriptan benzoate) — NDA215431, Jan 30, 2025. Applicant at approval: Axsome Therapeutics, Inc. source ↗
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