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solriamfetol

Generic: SOLRIAMFETOL HYDROCHLORIDE·Brand: SUNOSI, Sunosi

solriamfetol: developed by 1 company · 7 clinical trials tracked.

solriamfetol evidence translation

What we can confirm

What it means

Source-backed records connect solriamfetol to AXSM; that link alone does not prove the drug works.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

How could solriamfetol → AXSM affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence4 indications · 0 study sponsors

Related indications

excessive daytime sleepiness (EDS) associated with obstructive sleep apnea (OSA) or narcolepsy (adults)ADHDBinge-Eating DisorderMultiple Sclerosis

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (1)
CompanyPhase
Axsome Therapeutics, Inc. (AXSM)
excessive daytime sleepiness (EDS) associated with obstructi…
Approved
Clinical Trials (7)

An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD)

NCT07773883·Phase 3·AXSM
Enrolling by invitation

Primary endpoint: Treatment-Emergent Adverse Events (TEAEs)

Interventionalopen300 targetStarted 2026-08Completion 2027-122 sites · United StatesAxsome Therapeutics, Inc.

A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal Study of Solriamfetol in Subjects With Major Depressive Disorder With Excessive Daytime Sleepiness Symptoms

NCT07484217·Phase 3·AXSM
Recruiting

Primary endpoint: Time from randomization to relapse of depressive symptoms

InterventionalRandomizeddouble508 targetStarted 2026-02Completion 2028-1240 sites · United StatesAxsome Therapeutics, Inc.

An Open-Label and Double-Blind, Randomized Withdrawal Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Adults With Binge Eating Disorder

NCT06878976·Phase 3·AXSM
Enrolling by invitation

Primary endpoint: Time from randomization to relapse of binge eating in the RW segment

InterventionalRandomizeddouble236 targetStarted 2025-02Completion 2027-1233 sites · United StatesAxsome Therapeutics, Inc.

A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Solriamfetol in Excessive Sleepiness Associated With Shift Work Disorder

NCT06568367·Phase 3·AXSM
Recruiting

Primary endpoint: Change from Baseline to Week 12 in the mean sleep latency time as measured by the Maintenance of Wakefulness Test (MWT).

InterventionalRandomizeddouble520 targetStarted 2024-08Completion 2026-1249 sites · Canada, United StatesAxsome Therapeutics, Inc.

Solriamfetol for the Treatment of Fatigue in Patients With Multiple Sclerosis and Excessive Daytime Sleepiness

NCT06170970·Phase 2
Recruiting

Primary endpoint: Modified Fatigue Impact Scale (MFIS) Score

InterventionalRandomizedtriple46 targetStarted 2024-06Completion 2027-031 site · United StatesJohns Hopkins University

A Phase 3, Randomized, Double-blind, Placebo-Controlled Trial of Solriamfetol in Adults With Binge Eating Disorder (BED)

NCT06413433·Phase 3·AXSM
Recruiting

Primary endpoint: Change from Baseline to Week 12 in number of binge eating episodes

InterventionalRandomizeddouble450 targetStarted 2024-04Completion 2026-1245 sites · United StatesAxsome Therapeutics, Inc.

A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of Solriamfetol in Adults With ADHD.

NCT05972044·Phase 3·AXSM
Completed

Primary endpoint: Change from Baseline to Week 6 in the AISRS total score

InterventionalRandomizeddouble516 enrolledStarted 2023-07Completion 2025-0342 sites · United StatesAxsome Therapeutics, Inc.

Frequently asked questions

Who is developing solriamfetol?

solriamfetol is being developed by Axsome Therapeutics, Inc..

How many clinical trials involve solriamfetol?

BioSniper tracks 7 clinical trials involving solriamfetol.