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Solriamfetol

Phase 3

Excessive Sleepiness | Small molecule | Other |Axsome Therapeutics, Inc.|Last Updated: Nov 25, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment520
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06568367Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)PHASE3 RECRUITING 520Aug 1, 2024Dec 1, 2026Nov 25, 202540 United States, Canada
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Study Endpoints
Primary Endpoints
Change from Baseline to Week 12 in the mean sleep latency time as measured by the Maintenance of Wakefulness Test (MWT).
12 weeks
Change from Baseline to Week 12 in the Clinical Global Impressions of Severity of Illness (CGI-S) for sleepiness during the night shift.
12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Solriamfetol 150mgEXPERIMENTALUp to 12 weeks
Solriamfetol 300mgEXPERIMENTALUp to 12 weeks
PlaceboPLACEBO_COMPARATORUp to 12 weeks
Interventions
NameTypeDescription
Solriamfetol 150 mgDRUGSolriamfetol tablets, taken once daily
Solriamfetol 300 mgDRUGSolriamfetol tablets, taken once daily
PlaceboDRUGPlacebo tablets, taken once daily
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites40

Inclusion Criteria: * Meets International Classification of Sleep Disorders, Third Edition (ICSD-3) criteria for Shift Work Disorder (SWD) * Provides written informed consent to participate in the study before the conduct of any study procedures. * Male or female, aged 18 to 65 inclusive. Exclusio...

Countries:United StatesCanada
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06568367primaryCompletionDate: changed
LOWMay 24, 2026NCT06568367studyFirstPostDate: changed