Recent Updates
Recently added Catalysts

Rimegepant

Phase 3

Migraine, With or Without Aura | Small molecule | Neurology |Pfizer, Inc.|Last Updated: Feb 16, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials4
Total Enrollment7,814
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03461757Trial in Adult Subjects With Acute MigrainesPHASE3 COMPLETED 1,811Feb 27, 2018Oct 15, 2018Feb 16, 202369 United States
NCT03237845Safety and Efficacy in Adult Subjects With Acute MigrainesPHASE3 COMPLETED 1,499Jul 27, 2017Jan 31, 2018Feb 16, 202350 United States
NCT03235479Safety and Efficacy Study in Adult Subjects With Acute MigrainesPHASE3 COMPLETED 1,485Jul 18, 2017Jan 26, 2018Feb 16, 202350 United States
NCT03266588Open Label Safety Study in Acute Treatment of MigrainePHASE2 COMPLETED 3,019Aug 30, 2017Jul 15, 2019Feb 16, 202398 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Percentage of Participants With Freedom From Pain at 2 Hours Post-dose
2 hours post-dose

Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the electronic diary (eDiary). Pain freedom was defined as pain level of none.

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

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

Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period
PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks

An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition on-treatment in a patient or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. An SAE was defined as any event that met any of the following criteria: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received rimegepant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention.

Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period
PRN (2-8) and PRN (9-14) groups: Up to 52 weeks: Scheduled EOD + PRN group: Up to 12 weeks

Clinically significant laboratory abnormalities were defined as Grade 3 to 4 on-treatment laboratory test results according to numeric laboratory test criteria found in Common Technical Criteria for Adverse Events (CTCAE) Version 5.0 (2017) if available; otherwise, according to Division of Acquired Immune Deficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1 (2017) for Glucose, LDL-Cholesterol, Uric Acid, and Urinalysis. Laboratory test groups of clinical interest included hematology, serum chemistry, and urinalysis. Participants must have had a non-missing measurement in the on-treatment period to be included for a given parameter.

Secondary Endpoints
Percentage of Participants With Pain Relief at 2 Hours Post-dose
2 hours post-dose
Percentage of Participants With Freedom From Functional Disability 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
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1: Rimegepant 75 mgEXPERIMENTALParticipants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Arm 2: PlaceboPLACEBO_COMPARATORParticipants were administered a single sublingual dose of matching placebo for rimegepant (75 mg) ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
Rimegepant 75 mgEXPERIMENTALParticipants were administered a single oral dose of 75 mg of rimegepant tablet on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
PlaceboPLACEBO_COMPARATORParticipants were administered a single oral dose of matching placebo tablet for rimegepant (75 mg) on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.
RimegepantEXPERIMENTAL -
Interventions
NameTypeDescription
RimegepantDRUG75 mg ODT QD
PlaceboDRUGPlacebo ODT to match rimegepant dose QD
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites69

Key Inclusion Criteria: 1\. Subject has at least 1 year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition, Beta version \[1\] including the following: 1. Migraine attacks present for more than 1 ...

Countries:United States
Unlock Eligibility Criteria