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NCT06878976Phase 3ENROLLING BY INVITATION

Open-Label Safety Study of Solriamfetol in Subjects With Binge Eating Disorder

Study Summary

This is a Phase 3, multi-center, open-label study to evaluate the long-term safety and efficacy of solriamfetol in the treatment of binge eating disorder (BED) in adults.

Conditions
Binge-Eating Disorder
Interventions / Drugs
Solriamfetol 75mg, 150 mg, or 300 mg
View on ClinicalTrials.gov ↗
Sponsor
AXSM
Axsome Therapeutics
Neuroscience
D49/100
Study Details
Enrollment300 participants
Primary Completion—
Lead SponsorAxsome Therapeutics, Inc.
Data Retrieved2026-04-11 04:06:36.562753+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Current status: ENROLLING BY INVITATION.

Enrolled: 300 participants
Sponsor Catalyst Profile

Axsome Therapeutics (AXSM) is the sponsoring company for this trial. BiotechSign currently grades this company D (49/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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