Axsome Therapeutics
Axsome Therapeutics sponsors 28 registered US clinical trials on ClinicalTrials.gov, 6 of them currently recruiting, and 20 completed. 21 of these trials are in Phase 3-4 (later-stage) and 6 in Phase 1-2 (earlier-stage). The most-studied condition in this pipeline is Major Depressive Disorder, with 3 trials.
Trial Pipeline
28 total, page 1 of 1
Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol
NCT07484217
Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design
NCT07398417
Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)
NCT06568367
Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol
NCT06413433
A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms
NCT06223880
SUNOSI® (Solriamfetol) Pregnancy Registry
NCT06413420
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
NCT06736509
Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol
NCT06360419
A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)
NCT05972044
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation
NCT05557409
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)
NCT05550207
A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy (ENCORE)
NCT05113745
A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy
NCT05059223
Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration
NCT05008341
A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation
NCT04947553
Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study
NCT04789174
Assessing Clinical Outcomes in Alzheimer's Disease Agitation
NCT04797715
Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE)
NCT04634669
Mechanistic Evaluation of Response in TRD (MERIT)
NCT04608396
Initiating Early Control of Migraine Pain and Associated Symptoms
NCT04163185
Open-Label Safety Study of AXS-05 in Subjects With Depression
NCT04039022
Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT)
NCT04068051
A Trial of AXS-05 in Patients With Major Depressive Disorder
NCT04019704
Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)
NCT03881852
Maximizing Outcomes in Treating Acute Migraine
NCT03896009
Assessing Symptomatic Clinical Episodes in Depression
NCT03595579
Addressing Dementia Via Agitation-Centered Evaluation
NCT03226522
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder
NCT02741791
Phase Distribution
| Phase | Trial count |
|---|---|
| Phase 1 | 1 |
| Phase 2 | 5 |
| Phase 3 | 19 |
| Phase 4 | 2 |
Therapeutic Areas
What the Pipeline for Axsome Therapeutics Shows
According to the ClinicalTrials.gov registry, Axsome Therapeutics is linked to 28 US clinical trials across every stage of research activity. Of those, 6 studies are currently recruiting, about 21% of the sponsor's indexed portfolio, and 20 are already marked complete, representing roughly 71% of the total.
The phase mix for Axsome Therapeutics reports 21 late-stage studies (Phase 3 and Phase 4 combined) and 6 earlier-phase studies (Phase 1 and Phase 2).
The top therapeutic focus area indexed for Axsome Therapeutics is Major Depressive Disorder with 3 linked trials, and 9 other condition areas appear in the top list above.
How to read these pipeline numbers
Recruiting share is one of the more practical signals here: it reflects how much of a sponsor's research is presently open to new participants, while the completed share indicates the depth of finished work that has already contributed registry results. Both counts come directly from the public ClinicalTrials.gov dataset and are refreshed on the registry side; this page mirrors the latest data pull without altering it.
A portfolio weighted toward Phase 3 usually reflects an organization advancing candidates toward regulatory review, where the research centers on comparative efficacy and broader safety across larger populations. A heavier Phase 1 and Phase 2 tilt generally indicates exploratory work, safety, dosing, and early signal detection, and is common among research-forward sponsors that seed many early programs. Phase 4 entries, when present, track interventions already in real-world use and typically focus on long-term safety, effectiveness across subgroups, or formulation comparisons.
That distribution is a quick read of where the organization concentrates its research attention; it does not imply product availability, market share, or any clinical endorsement. All numbers on this page come from ClinicalTrials.gov maintained by the National Library of Medicine, and counts can shift as new studies are registered or existing ones update their status. This information is provided for reference and educational purposes only, not as medical, investment, or regulatory advice, verify current details directly with ClinicalTrials.gov before relying on any figure here.
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page aggregates every registered trial from this sponsor, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.