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AXS-14

Phase 3

Fibromyalgia | Small molecule | Musculoskeletal |Axsome Therapeutics, Inc.|Last Updated: Jul 24, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment920
FDA Designations
No designations recorded
Clinical trial landscape

AXS-14 · 2 trials · 1 indication

Phase 3 2
NCT07637162Open-Label Safety Study of AXS-14 in Subjects With FibromyalgiaFibromyalgia
ENROLLING BY_INVITATION300 Analytics
NCT07398417Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research DesignFibromyalgia
RECRUITING620 Analytics
PHASE3ENROLLING BY_INVITATION
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
NCT07637162300
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PHASE3RECRUITING
Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design
Fibromyalgia
NCT07398417620
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Study Endpoints
Primary Endpoints
Long-term Safety
Up to 52 weeks.

Incidence of treatment-emergent adverse events following dosing with AXS-14

Time from randomization to loss of therapeutic response
12 Weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AXS-14 (esreboxetine)EXPERIMENTALUp to 52 weeks.
PlaceboPLACEBO_COMPARATOR• Up to 12 weeks in the randomized double-blind period (if applicable)
Interventions
NameTypeDescription
AXS-14 (esreboxetine)DRUGAXS-14 tablets taken twice daily.
PlaceboDRUGPlacebo tablets taken once daily
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Participation in AXS-14-FM-301. Exclusion Criteria: * Unable to comply with study procedures. * Medically inappropriate for study participation in the opinion of the Investigator.

Countries:United States
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Competitive Landscape -Fibromyalgia 5 trials
CompanyTickerTrialsLead PhaseDrugs
Axsome Therapeutics, Inc.AXSM1PHASE3AXS-14
Grace Therapeutics, Inc.GRCE1 - Undisclosed
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Recent Changes (Last 90 Days)
LOWJul 24, 2026NCT07398417lastUpdatePostDate: changed
LOWJul 24, 2026NCT07637162lastUpdatePostDate: changed
LOWJun 9, 2026NCT07637162NEW_TRIAL: changed
LOWJun 9, 2026NCT07637162NEW_TRIAL: changed
LOWJun 9, 2026NCT07637162NEW_TRIAL: changed
LOWJun 9, 2026NCT07637162NEW_TRIAL: changed
LOWMay 26, 2026NCT07398417primaryCompletionDate: changed
LOWMay 24, 2026NCT07398417studyFirstPostDate: changed