JZP-110 · program
Solriamfetol (Sunosi) for Binge eating disorder
Indications for JZP-110: Binge eating disorder · Phase 3 Excessive daytime sleepiness · Phase 3 Major depressive disorder · Phase 3 Attention-deficit/hyperactivity disorder · Phase 3
Axsome Therapeutics' development of solriamfetol for binge eating disorder (BED). The lead trial is the Phase 3 ENGAGE study (NCT06413433), a randomized, double-blind, placebo-controlled, multicenter trial in which approximately 450 adults with BED are randomized 1:1:1 to solriamfetol 150 mg, solriamfetol 300 mg, or placebo once daily for 12 weeks; the primary endpoint is the change from baseline to Week 12 in the number of binge eating episodes. The first patient was screened in March 2024; CT.gov status is recruiting. Axsome guides topline ENGAGE results to the second half of 2026. A separate open-label, long-term safety and efficacy study (NCT06878976; up to 52 weeks; solriamfetol 75/150/300 mg) supports the program. The mechanistic rationale is solriamfetol's dopamine/norepinephrine reuptake inhibition plus TAAR1 agonism. Solriamfetol remains approved as Sunosi for excessive daytime sleepiness in narcolepsy/OSA (a separate indication); it is not FDA-approved for BED.
Development timeline
- UpcomingpendingENGAGE Phase 3 (solriamfetol in binge eating disorder) topline results anticipated in the second half of 2026.↗
- Axsome started an open-label, long-term safety and efficacy study of solriamfetol in BED (NCT06878976; solriamfetol 75/150/300 mg once daily for up to 52 weeks), supporting the ENGAGE program.
- Axsome initiated the ENGAGE Phase 3 trial of solriamfetol in binge eating disorder (NCT06413433); first patient screened in March 2024. ~450 adults, 1:1:1 to solriamfetol 150 mg, 300 mg, or placebo for 12 weeks; primary endpoint change in binge eating episodes at Week 12.↗
Readouts
- 2H 2026AnticipatedTopline datapendingNCT06413433
ENGAGE Phase 3 (solriamfetol in binge eating disorder) topline results anticipated in the second half of 2026. ↗
Clinical trials in Binge eating disorder
NCT06878976Phase 3Recruitingn=300
An Open-Label Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Adults With Binge Eating Disorder
NCT06413433ENGAGEPhase 3Recruitingn=450
A Phase 3, Randomized, Double-blind, Placebo-Controlled Trial of Solriamfetol in Adults With Binge Eating Disorder (BED) (ENGAGE)
Formulations
| Formulation | Route | Regimen | Pharmacokinetics |
|---|---|---|---|
| Solriamfetol oral tablet (Sunosi) Film-coated tablets; administer once daily upon awakening. In excessive daytime sleepiness (narcolepsy/OSA), recommended dose 75-150 mg/day; initiate at 75 mg (OSA) or 37.5 mg (narcolepsy) and titrate; max 150 mg/day. Avoid administration within 9 hours of planned bedtime. | Oral | Once daily | t½ 7.1 h · Tmax 2 h · F 95% |
Mechanism of action
Selective dopamine and norepinephrine reuptake inhibitor (DNRI) with additional agonist activity at trace amine-associated receptor 1 (TAAR1). Inhibits dopamine and norepinephrine reuptake with IC50 values of ~2.9 uM and ~4.4 uM (binding Ki ~14.2 uM at DAT and ~3.7 uM at NET); negligible serotonin transporter activity (Ki ~81.5 uM). Acts as a human/rodent TAAR1 agonist (EC50 ~10-16 uM) at concentrations overlapping its transporter activity -- a mechanism not shared by modafinil or bupropion -- and is a weak 5-HT1A agonist. The combined monoaminergic/TAAR1 profile is hypothesized to drive wake-promotion and is being tested for antidepressant and pro-vigilance effects in MDD with excessive daytime sleepiness.
| Target | Action | Affinity |
|---|---|---|
| NETprimarySLC6A2 | Reuptake inhibitor | Ki 3700 nMⓘ |
| DATSLC6A3 | Reuptake inhibitor | Ki 14200 nMⓘ |
| TAAR1TAAR1 | Agonist | —ⓘ |
← Full JZP-110 compound page (identity, identifiers, all indications)
Sources
- Axsome Therapeutics Initiates ENGAGE Phase 3 Trial of Solriamfetol for the Treatment of Binge Eating Disorder (Axsome press release, April 1, 2024; via BioSpace) — Axsome Therapeutics (GlobeNewswire) / BioSpace
- Axsome Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update (smoking-cessation pivotal Phase 2/3 planned Q2 2026) — Axsome Therapeutics (GlobeNewswire)
- Baladi et al. Characterization of the Neurochemical and Behavioral Effects of Solriamfetol (JZP-110), a Selective Dopamine and Norepinephrine Reuptake Inhibitor. J Pharmacol Exp Ther 2018;366(2):367-376 (PMID 29891587; DOI 10.1124/jpet.118.248120) — Journal of Pharmacology and Experimental Therapeutics (PubMed)
- ENGAGE: A Phase 3 Randomized, Double-blind, Placebo-Controlled Trial of Solriamfetol in Adults With Binge Eating Disorder (NCT06413433) — ClinicalTrials.gov
- Open-Label Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Adults With Binge Eating Disorder (NCT06878976) — ClinicalTrials.gov
- SUNOSI (solriamfetol) tablets, for oral use, CIV — Full Prescribing Information — FDA / DailyMed (NLM)