Axsome's ENGAGE trial tests solriamfetol in binge eating disorder past a stale completion date
Axsome guides to H2 2026 topline data for solriamfetol in binge eating disorder even as the registry still lists the trial recruiting against a December 2025 completion date.
Executive Summary
- Axsome Therapeutics is running a registrational Phase 3 trial testing whether solriamfetol, already sold for a different sleep-disorder indication, can reduce binge eating episodes against placebo.
- The company continues to guide toward a second-half 2026 data window even though the trial's own listed completion date has already passed, a gap the sponsor has not resolved with an updated registry date.
- No other program combines this trial's target profile in binge eating disorder, leaving the readout without a direct mechanism-matched comparator, though multiple other drug classes have been tested and failed to reach approval in the same population.
- A positive, well-powered result would give Axsome a second approved use for an existing marketed drug and would be the first mechanism of its kind to clear a Phase 3 bar in this disorder.
The trial
ENGAGE (NCT06413433) is a Phase 3, randomized, placebo-controlled trial testing solriamfetol against placebo in adults aged 18 to 55 with binge eating disorder, diagnosed under DSM-5 criteria. The trial enrolls to a target of 450 patients across two experimental arms and one placebo arm, and its primary endpoint is the change from baseline to Week 12 in the number of binge eating episodes. Axsome markets solriamfetol as SUNOSI for excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and the drug carries an existing FDA-approved oral tablet formulation under that brand. ENGAGE tests the same molecule in a new indication rather than a new chemical entity. NCT06413433Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using SolriamfetolNCT06413433
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
Timing tension
The registry lists the trial's primary completion date as December 1, 2025, and the trial status remains Recruiting as of the most recent registry update. Axsome's own guidance, repeated in a February 2026 disclosure and again in a subsequent business update, points to topline data in the second half of 2026. That guided window, July 1 to December 31, 2026, runs later than the trial's own listed completion date, a gap the sponsor's public disclosures have not reconciled. The trial has logged no protocol amendments since its initial registration in May 2024, and enrollment has held flat at its 450-patient target with no growth or reduction. NCT06413433+1Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using SolriamfetolNCT06413433Axsome Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides ...Feb 23, 2026
The endpoint bar
The single primary endpoint, reduction in binge eating episode frequency from baseline to Week 12 versus placebo, is the same category of measure regulators have used to evaluate other candidates in this disorder. Several earlier programs tested comparable stimulant-class and reuptake-inhibitor mechanisms in binge eating disorder, including Sumitomo Pharma America's dasotraline and Takeda's lisdexamfetamine dimesylate, both of which reached Phase 3 in this indication. Lisdexamfetamine dimesylate went on to FDA approval for binge eating disorder under the brand Vyvanse, establishing that a dopamine-transporter-acting stimulant can clear this endpoint bar in a registrational setting.
Competitive position
No other trial in binge eating disorder combines solriamfetol's TAAR1-agonist, dopamine and norepinephrine reuptake inhibitor, and 5-HT1A-agonist profile; the closest programs on record share only the disorder or the small-molecule modality, including duloxetine, memantine, armodafinil, and topiramate trials run by academic sponsors such as the Lindner Center of HOPE and the University of Cincinnati. None of those shares solriamfetol's specific mechanism combination. The absence of a mechanism-matched comparator means ENGAGE's result, whichever direction it lands, will stand largely on its own rather than against a peer readout in the same target class.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.