Pipeline — registered trials by phase
A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms
— · Major Depressive Disorder · Recruiting · est. 2026-03
Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study
— · Excessive Daytime Sleepiness, Obstructive Sleep Apnea, Impaired Cognitive Function · Completed · est. 2022-09-19
SUNOSI® (Solriamfetol) Pregnancy Registry
— · Narcolepsy, Obstructive Sleep Apnea, Pregnant Women and Their Offspring · Recruiting · est. 2029-09
Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration
— · Narcolepsy, Obstructive Sleep Apnea, Excessive Daytime Somnolence · Completed · est. 2022-04-15
Assessing Symptomatic Clinical Episodes in Depression
— · Major Depressive Disorder · Completed · est. 2019-01-07
Mechanistic Evaluation of Response in TRD (MERIT)
— · Treatment Resistant Depression, Major Depressive Disorder · Completed · est. 2021-07-30
Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)
— · Narcolepsy, Cataplexy Narcolepsy, Excessive Sleepiness · Completed · est. 2019-11-27
Maximizing Outcomes in Treating Acute Migraine
— · Migraine · Completed · est. 2019-12-10
Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT)
— · Migraine · Completed · est. 2020-09-22
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)
— · Migraine · Completed · est. 2024-11-27
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder
— · Treatment Resistant Major Depressive Disorder · Completed · est. 2020-03-20
A Trial of AXS-05 in Patients With Major Depressive Disorder
— · Depression, Major Depressive Disorder · Completed · est. 2019-11-26
A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy
— · Narcolepsy, Cataplexy, Excessive Daytime Sleepiness · Completed · est. 2024-03-15
A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder
— · Binge-Eating Disorder · Enrolling By Invitation · est. 2027-12
Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol
— · Major Depressive Disorder · Completed · est. 2024-12-31
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
— · Fibromyalgia · Enrolling By Invitation · est. 2028-05
Addressing Dementia Via Agitation-Centered Evaluation
— · Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation,Psychomotor · Completed · est. 2020-04-17
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation
— · Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation · Completed · est. 2024-11-21
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-3)
— · ADHD · Recruiting · est. 2028-06-30
Open-Label Safety Study of AXS-05 in Subjects With Depression
— · Major Depressive Disorder, Treatment Resistant Depression, Depression · Completed · est. 2020-10-23
Initiating Early Control of Migraine Pain and Associated Symptoms
— · Migraine · Completed · est. 2020-03-16
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
— · ADHD · Enrolling By Invitation · est. 2027-12
A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy (ENCORE)
— · Narcolepsy, Cataplexy, Excessive Daytime Sleepiness · Completed · est. 2024-11-15
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
— · Smoking Cessation · Recruiting · est. 2027-12
Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)
— · Excessive Sleepiness, Shift-work Disorder · Recruiting · est. 2026-12
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
— · ADHD · Recruiting · est. 2028-06-30
Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design
— · Fibromyalgia · Recruiting · est. 2028-03
Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol
— · Binge-Eating Disorder · Recruiting · est. 2026-12
Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol
— · Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms · Recruiting · est. 2028-12
A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation
— · Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation, Psychomotor · Completed · est. 2024-12-03
A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)
— · ADHD · Completed · est. 2025-02-07
Assessing Clinical Outcomes in Alzheimer's Disease Agitation
— · Agitation in Patients With Dementia of the Alzheimer's Type, Alzheimer Disease, Agitation,Psychomotor · Completed · est. 2022-11-21
AuvelityBupropion Hydrochloride
SymbravoMeloxicam
Source: ClinicalTrials.gov (trials where Axsome is lead sponsor; 32 active or completed) and Drugs@FDA (2 approved products). Registry data can include older or partnered programs; the company's own pipeline page is the official list.
SEC filings — insider trading forms excluded
- 10-Q2026-08-10Quarterly report
- 8-K2026-08-10Current report (material event)
- SCHEDULE 13G/A2026-07-27SCHEDULE 13G/A
- 8-K2026-07-15Current report (material event)
- 8-K2026-06-09Current report (material event)
- 8-K2026-06-09Current report (material event)
- 8-K2026-06-03Current report (material event)
- 10-Q2026-05-04Quarterly report
- 8-K2026-05-04Current report (material event)
- 8-K2026-04-30Current report (material event)
- ARS2026-04-24Annual report to holders
- DEFA14A2026-04-24DEFA14A
- DEF 14A2026-04-24Proxy statement
- 8-K2026-04-01Current report (material event)
- SCHEDULE 13G/A2026-03-26SCHEDULE 13G/A
- 10-K2026-02-23Annual report
- 8-K2026-02-23Current report (material event)
- 8-K2026-02-17Current report (material event)
- 8-K2026-01-12Current report (material event)
- 8-K2025-12-31Current report (material event)
- S-3ASR2025-11-03S-3ASR
- 10-Q2025-11-03Quarterly report
- 8-K2025-11-03Current report (material event)
- 8-K2025-08-20Current report (material event)
- SCHEDULE 13G/A2025-08-14SCHEDULE 13G/A
- S-82025-08-07Employee stock plan
- 10-Q2025-08-04Quarterly report
- 8-K2025-08-04Current report (material event)
- 8-K2025-06-10Current report (material event)
- 8-K2025-06-09Current report (material event)
- 8-K2025-06-09Current report (material event)
- 8-K2025-05-27Current report (material event)
- SCHEDULE 13G/A2025-05-15SCHEDULE 13G/A
- 8-K2025-05-13Current report (material event)
- 10-Q2025-05-05Quarterly report
- 8-K2025-05-05Current report (material event)
- ARS2025-04-25Annual report to holders
- DEFA14A2025-04-25DEFA14A
- DEF 14A2025-04-25Proxy statement
- 8-K2025-04-01Current report (material event)
Source: SEC EDGAR. Forms 3/4/5 and 144 (insider transactions) are intentionally left out.