Recent Updates
Recently added Catalysts

Solriamfetol , , or

Phase 3

Binge-Eating Disorder | Small molecule | Psychiatry |Axsome Therapeutics, Inc.|Last Updated: Nov 25, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment750
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06878976Open-Label Safety Study of Solriamfetol in Subjects With Binge Eating DisorderPHASE3 ENROLLING BY_INVITATION 300Feb 20, 2025Dec 1, 2026Nov 25, 202531 United States
NCT06413433Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using SolriamfetolPHASE3 RECRUITING 450Apr 26, 2024Dec 1, 2025Nov 21, 202545 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Long-term Safety
Up to 52 weeks.

Incidence of treatment-emergent adverse events following dosing with solriamfetol

Change from Baseline to Week 12 in number of binge eating episodes
12 weeks
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SolriamfetolEXPERIMENTALUp to 52 weeks.
Solriamfetol 150 mgEXPERIMENTALUp to 12 weeks
Solriamfetol 300 mgEXPERIMENTALUp to 12 weeks
PlaceboPLACEBO_COMPARATORUp to 12 weeks
Interventions
NameTypeDescription
Solriamfetol 75mg, 150 mg, or 300 mgDRUGTaken once daily.
Solriamfetol 150 mgDRUGSolriamfetol tablets, taken once daily
Solriamfetol 300 mgDRUGSolriamfetol tablets, taken once daily
PlaceboDRUGPlacebo tablets, taken once daily
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 56 Years
SexALL
Healthy VolunteersNo
Study Sites31

Inclusion Criteria: * Completion of the treatment period in Study SOL-BED-301. * Able to comply with study procedures. Exclusion Criteria: * Significant change in vital signs, medical history or concomitant medications since enrolling in the SOL-BED-301 study which, in the opinion of the Investig...

Countries:United States
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06413433primaryCompletionDate: changed
LOWMay 26, 2026NCT06878976primaryCompletionDate: changed
LOWMay 24, 2026NCT06413433studyFirstPostDate: changed
LOWMay 24, 2026NCT06878976studyFirstPostDate: changed