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ODT2 Test formulation

Phase 1

Migraine | Small molecule | Neurology |Pfizer, Inc.|Last Updated: May 22, 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
RandomizedCONTROLLED
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07594769A Study to Compare the Blood Levels of Two Dosage Formulations of the Study Medicine in Healthy AdultsPHASE1 NOT YET_RECRUITING 36 — — May 18, 2026Sep 7, 2026May 22, 20261 Belgium
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Study Endpoints
Primary Endpoints
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of the test and reference formulations
Pre-dose to 72 hours
Area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast) of the test and reference formulations
Pre-dose to 72 hours
Maximum observed plasma concentration (Cmax) of test and reference formulations
Pre-dose to 72 hours
Secondary Endpoints
Number of participants with treatment emergent adverse events (TEAEs)
From baseline up to 36 days after last dose of study intervention
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
Treatment Sequence 1EXPERIMENTAL -
Treatment Sequence 2EXPERIMENTAL -
Interventions
NameTypeDescription
ODT2 Test formulationDRUGTest Formulation
ODT Reference formulationDRUGReference Formulation
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male or female participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECGs. 2. Hav...

Countries:Belgium
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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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