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Erenumab

Phase 3

Migraine | Monoclonal antibody | Neurology |Novartis AG|Last Updated: Oct 16, 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_CONTROLLEDDMC
Total Trials1
Total Enrollment557
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03867201Study of Efficacy and Safety of Erenumab in Adult Chronic Migraine PatientsPHASE3 COMPLETED 557 — — Aug 26, 2019Apr 30, 2024Oct 16, 202563 China, India +7
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Study Endpoints
Primary Endpoints
Change From Baseline in Monthly Migraine Days During the Last 4 Weeks of the 12-week Treatment Period
baseline (4 weeks period prior to start of study drug), week 9 to 12

A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura, lasting for ≥4 continuous hours, and meeting at least one of the following criteria: 1. ≥2 of the following pain features: * Unilateral * Throbbing * Moderate to severe * Exacerbated with exercise/physical activity 2. ≥1 of the following associated symptoms: * Nausea and/or vomiting * Photophobia and phonophobia

Secondary Endpoints
Change From Baseline in Migraine-related Disability and Productivity as Measured by the mMIDAS During the Last 4 Weeks of the 12-week Treatment Period
baseline (4 weeks period prior to start of study drug), week 9 to 12
Number of Participants With at Least 50% Reduction From Baseline in Monthly Migraine Days During the Last 4 Weeks of the 12-week Treatment Period
baseline (4 weeks period prior to start of study drug), week 9 to 12
Change From Baseline in Monthly Acute Headache Medication Days During the Last 4 Weeks of the 12-week Treatment Period
baseline (4 weeks period prior to start of study drug), week 9 to 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ErenumabEXPERIMENTALAdministered by pre-filled syringe
PlaceboPLACEBO_COMPARATORAdministered by pre-filled syringe
Interventions
NameTypeDescription
ErenumabBIOLOGICALAdministered by pre-filled syringe
PlaceboOTHERAdministered by pre-filled syringe
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites63

key inclusion Criteria: 1. History of at least 5 attacks of migraine 2. ≥ 15 headache days of which ≥ 8 headache days meet criteria as migraine days during the baseline period 3. \>=80% diary compliance during the baseline period Key exclusion Criteria: 1. Older than 50 years of age at migraine o...

Countries:ChinaIndiaMalaysiaPhilippinesSingaporeSouth KoreaTaiwanThailandVietnam
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Competitive Landscape -Migraine 32 trials
CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV15PHASE3Atogepant, Topiramate, Ubrogepant, MEDI0618
Pfizer Inc.PFE9PHASE3Rimegepant, Rimegepant/BHV3000, Zavegepant, Various, Rimegepant for acute migraine treatment
Eli Lilly and CompanyLLY2PHASE3Galcanezumab
Amgen Inc.AMGN2PHASE3Erenumab Dose 1, erenumab-aooe
Ki Health Partners. LLCRVNC1 — Daxibotulinumtonix A
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