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Axsome Therapeutics clinical trials

Source: ClinicalTrials.gov, U.S. National Library of Medicine — current trials in our USA register with Axsome Therapeutics as lead sponsor. Synced 26 Sep 2026
12Current trials
9Recruiting now
5Drugs in these trials
1Trial register
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 — Top 14 finalist
Compiled from ClinicalTrials.gov and CTIS registry records · Last verified · Editorial standards
At a glance

Axsome Therapeutics is the lead sponsor of 12 current clinical trials in our USA register. 9 are recruiting patients now. The most common phase is Phase 3. The drugs named most often in its trials are Solriamfetol, Bupropion and Dextromethorphan-bupropion. The most-studied condition is ADHD.

ClinicalTrials.gov trials by status

  • Recruiting975%
  • By invitation325%

Trials by phase

  • Phase 31083%
  • Observational18%
  • Phase 418%
01

Clinical trials sponsored by Axsome Therapeutics

12 on ClinicalTrials.gov
StudyPhaseStatusStartRegisters
Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)
NCT06568367 · Excessive Sleepiness, Shift-work Disorder
Phase 3 Recruiting 2024-08 USA
Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol
NCT07484217 · Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms
Phase 3 Recruiting 2026-02 USA
Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol
NCT06413433 · Binge-Eating Disorder
Phase 3 Recruiting 2024-04 USA
SUNOSI® (Solriamfetol) Pregnancy Registry
NCT06413420 · ClinicalTrials.gov ↗ · Narcolepsy, Obstructive Sleep Apnea, Pregnant Women and Their Offspring
Observational Recruiting 2019-07 USA
Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design
NCT07398417 · ClinicalTrials.gov ↗ · Fibromyalgia
Phase 3 Recruiting 2026-01 USA
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
NCT07717879 · ClinicalTrials.gov ↗ · ADHD
Phase 3 Recruiting 2026-07 USA
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-3)
NCT07717892 · ClinicalTrials.gov ↗ · ADHD
Phase 3 Recruiting 2026-06 USA
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
NCT07766655 · ClinicalTrials.gov ↗ · Smoking Cessation
Phase 3 Recruiting 2026-08 USA
A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms
NCT06223880 · ClinicalTrials.gov ↗ · Major Depressive Disorder
Phase 4 Recruiting 2023-12 USA
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
NCT07637162 · ClinicalTrials.gov ↗ · Fibromyalgia
Phase 3 By invitation 2026-04 USA
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
NCT07773883 · ClinicalTrials.gov ↗ · ADHD
Phase 3 By invitation 2026-08 USA
A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder
NCT06878976 · ClinicalTrials.gov ↗ · Binge-Eating Disorder
Phase 3 By invitation 2025-02 USA

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Titles and statuses are copied from the registry as published.

02

Drugs in Axsome Therapeutics trials

5 compounds

Drugs and biologicals named as interventions in these trials, with the number of this sponsor's trials that name each one. Placebos and generic comparators are excluded.

03

Conditions in Axsome Therapeutics trials

11 conditions
ADHD3Binge-Eating Disorder2Fibromyalgia2Excessive Sleepiness1Shift-work Disorder1Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms1Narcolepsy1Obstructive Sleep Apnea1Pregnant Women and Their Offspring1Smoking Cessation1Major Depressive Disorder1
04

By trial register

RegisterTrialsRecruiting
Clinical trials in USA129

A trial with sites in more than one country appears in each of those registers.

05

Questions about Axsome Therapeutics trials

How many clinical trials does Axsome Therapeutics sponsor?

Axsome Therapeutics is the lead sponsor of 12 current trials on ClinicalTrials.gov in our USA register, as of the registry sync on 26 September 2026. Completed and withdrawn studies are not counted.

Are Axsome Therapeutics trials recruiting?

Yes. 9 of its 12 ClinicalTrials.gov trials are recruiting. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Which drugs is Axsome Therapeutics testing?

Its current trials name 5 drugs and biologicals as interventions. The most frequent are Solriamfetol (6), Bupropion (2), Dextromethorphan-bupropion (2), Solriamfetol A (2) and Solriamfetol B (2). The number in brackets is how many of its trials name each drug.

Where does this information come from?

Every trial, status, phase and condition on this page is copied from public ClinicalTrials.gov and EU CTIS records by a daily sync, grouped by the sponsor name each registry records. It says nothing about the organisation beyond its registered trials, and it is not medical advice.

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How this page is built

Everything on this page is copied from public registry records — it is not written from memory, and nothing here describes the organisation beyond its registered trials. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our trial registers and groups every current trial by its lead sponsor name, ignoring legal-form suffixes such as Inc. or Ltd. A small, hand-checked list joins the same organisation's different registry names (for example its EU legal entity). There is no AI drafting and no per-sponsor editorial pass. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The the registries data on this page was last retrieved on 26 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.