Recent Updates
Recently added Catalysts

Rimegepant/BHV3000

Phase 3

Pediatric Migraine | Small molecule | Neurology |Pfizer, Inc.|Last Updated: Aug 14, 2026

Target and mechanism

Molecular targetCALCRL
Target classAntagonist
ModalitySmall molecule

Also known as Rimegepant, Rimegepant (PF-07899801)

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment2,100

FDA Designations

No designations recorded

Clinical trial landscape

Rimegepant/BHV3000 · 1 trial · 1 indication

Phase 3 1
NCT04649242Randomized Study in Children and Adolescents With Migraine: Acute TreatmentPediatric Migraine
RECRUITING2,100 Analytics
PHASE3RECRUITING
Randomized Study in Children and Adolescents With Migraine: Acute Treatment
Pediatric MigraineUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the efficacy of rimegepant compared with placebo in the acute treatment of migraine in adolescent population (≥ 12 to <18 years of age) as measured by pain freedom using the number of patients reporting no pain.
2 hours post-dose

Pain freedom will be assessed in adolescent population (≥ 12 to \< 18 years of age) on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe).

Secondary Endpoints

To compare rimegepant with placebo for pain freedom in children and adolescents combined.
2 hours post-dose
To compare rimegepant with placebo on freedom from the most bothersome symptom (MBS) associated with migraine in adolescents.
2 hours post-dose
To compare rimegepant with placebo on the probabilities of requiring rescue medication within in adolescents.
Within 24 hours and 48 hours of initial treatment
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BHV3000 (active drug)ACTIVE_COMPARATORBHV3000 (rimegepant) 75 mg or 50 mg ODT
PlaceboPLACEBO_COMPARATORMatching 75 mg or 50 mg ODT placebo

Interventions

NameTypeDescription
Rimegepant/BHV3000DRUGBHV3000 (rimegepant) 75 mg or 50 mg ODT
Matching placeboDRUGMatching 75 mg or 50 mg ODT placebo
Unlock Study Design Details

Eligibility Criteria

Age Range6 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites245

Inclusion Criteria: 1. History of migraine (with or without aura) for \> 6 months before Screening according to the IHS Classification ICHD-319 specifications for pediatric migraine. History may be verified using both medical records and recall by the participant and/or participant's parent(s)/lega...

Countries:United StatesCanadaChinaJapanMexicoPolandSpainSwedenUnited Kingdom
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

LOWAug 14, 2026NCT04649242lastUpdatePostDate: changed
LOWAug 14, 2026NCT04649242lastUpdatePostDate: changed
LOWJul 29, 2026NCT04649242lastUpdatePostDate: changed
LOWJul 29, 2026NCT04649242lastUpdatePostDate: changed
LOWJul 9, 2026NCT04649242lastUpdatePostDate: changed
LOWJul 9, 2026NCT04649242lastUpdatePostDate: changed
LOWJul 2, 2026NCT04649242lastUpdatePostDate: changed
LOWJul 2, 2026NCT04649242lastUpdatePostDate: changed
LOWJul 2, 2026NCT04649242lastUpdatePostDate: changed
LOWJul 2, 2026NCT04649242lastUpdatePostDate: changed
LOWJun 16, 2026NCT04649242lastUpdatePostDate: changed
LOWJun 16, 2026NCT04649242lastUpdatePostDate: changed
LOWJun 16, 2026NCT04649242lastUpdatePostDate: changed

Frequently asked questions about Rimegepant/BHV3000

What is Rimegepant used for?

Rimegepant is an investigational small molecule being developed for migraine, including acute treatment of migraine, preventive treatment of migraine, and migraine with or without aura. It is also being studied for pediatric migraine and for intermittent prevention of menstrual migraine. Rimegepant is in Phase 3 clinical development.

What does Rimegepant target?

Rimegepant is a small molecule that targets the calcitonin gene-related peptide (CGRP) receptor, which plays a role in migraine pathophysiology. By blocking this receptor, rimegepant is designed to treat and prevent migraine attacks. It is being studied for acute and preventive treatment of migraine.

Who makes Rimegepant?

Rimegepant is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting Phase 3 clinical trials of rimegepant for migraine indications, including pediatric migraine and menstrual migraine prevention.

What phase is Rimegepant in?

Rimegepant is in Phase 3 clinical development. It is not FDA approved and remains investigational. Pfizer is conducting multiple Phase 3 trials, including studies in pediatric subjects for acute migraine treatment, adolescents with frequent migraine, and women for intermittent prevention of menstrual migraine.

What clinical trials is Rimegepant in?

Rimegepant is being studied in several Phase 3 trials, including NCT04743141 for acute migraine treatment in pediatric subjects, NCT06616194 for adolescents with frequent migraine, and NCT06641466 for intermittent prevention of menstrual migraine. A Phase 2 trial, NCT03732638, evaluated rimegepant for migraine prevention in adults.

Is Rimegepant the same as PF-07899801 or BHV3000?

Yes, Rimegepant is also known as PF-07899801 and BHV3000. These alternative names refer to the same investigational drug being developed by Pfizer for migraine treatment and prevention. Rimegepant is currently in Phase 3 clinical trials for multiple migraine indications.