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BHV-2100

Phase 2

Migraine | Small molecule | Neurology |Biohaven Ltd.|Last Updated: Feb 25, 2026

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 Enrollment647
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06603623Efficacy and Safety Trial of BHV-2100 for the Acute Treatment of MigrainePHASE2 COMPLETED 647Oct 10, 2024Mar 28, 2025Feb 25, 202660 United States
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Study Endpoints
Primary Endpoints
Percentage of Participants With Freedom From Pain at 2 Hours Post-dose
2 hours post-dose

Pain levels are assessed on a 4-point scale (none, mild, moderate, severe) using the electronic diary (eDiary). Pain freedom is defined as pain level of none. Coprimary endpoints will be tested hierarachically by dose

Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose
2 hours post-dose

MBS is reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) is assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Freedom from MBS is defined as MBS reported at onset that was absent post-dose. Coprimary endpoints will be tested hierarachically by dose

Secondary Endpoints
Percentage of Participants With Pain Relief at 2 Hours Post-dose
2 hours post-dose
Percentage of Participants With Return to Normal Function at 2 Hours Post-dose
2 hours post-dose
Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose
From 2 hours up to 24 hours post-dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BHV-2100 75 mgEXPERIMENTAL -
BHV-2100 150 mgEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
BHV-2100DRUGBHV-2100 75mg
PlaceboDRUGmatching placebo
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersNo
Study Sites60

Key Inclusion Criteria: Participants with at least 1 year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition,19 including the following: 1. 2-8 migraine headache attacks of moderate or severe inten...

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMApr 8, 2026NCT06603623TRIAL_REMOVED: changed
MEDIUMApr 8, 2026NCT06603623TRIAL_REMOVED: changed