Nurtec

(Rimegepant)

ApprovedSmall molecule

Rimegepant is used to treat acute migraine headaches, including the pain and other symptoms like nausea and sensitivity to light. It can also be used to prevent migraines from occurring in people who get them frequently.[2] Nurtec is currently approved and in use across 10 indications[4].[1]

Nurtec is one of 304 small molecule programs targeting PTSD. It is currently in Approved.

Indications

Total Trials

Active Trials

303

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

PTSDApproved

Migraine DisorderActive, not recruiting

Irritable Bowel SyndromeApproved

SinusitisApproved

Temporomandibular Joint DisorderApproved

EndometriosisNot yet recruiting

MigraineCompleted

Pancreatic Ductal AdenocarcinomaNot yet recruiting

Colorectal CancerNot yet recruiting

PTSDApproved

Approved

Migraine DisorderApproved

Active, not recruiting

Irritable Bowel SyndromeApproved

Approved

SinusitisApproved

Approved

Temporomandibular Joint DisorderApproved

Approved

EndometriosisPhase 2

Not yet recruiting

MigraineApproved

Completed

Pancreatic Ductal AdenocarcinomaPhase 2

Not yet recruiting

Colorectal CancerPhase 2

Not yet recruiting

Competition

Competitive Landscape

268 competitors in Colorectal Cancer

#DrugCompanyPhaseTrials

Stivarga

Bayer

Phase 3

39 2

Nurtec

Pfizer

Approved

1 3

Acetylsalicylic Acid

Bayer

Phase 3

7 4

Telisotuzumab Adizutecan

AbbVie

Phase 3

2 5

TAS 102

Taiho Oncology, Inc.

Phase 3

8 6

Huaier Granule

QQidong Gaitianli Medicines Co., Ltd

Phase 3

4 7

Cytokine-Induced Killer Cells

TThe First People's Hospital of Changzhou

Phase 3

2 8

IBI363

Innovent Biologics (Suzhou) Co. Ltd.

Phase 3

1 9

Iron Isomaltoside

TThomas Jefferson University

Phase 3

3 10

Tucidinostat

CChipscreen Biosciences, Ltd.

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Migraine

NCT06985342

Phase 2Active, not recruiting

Study completion

NCT06992674

Post-ApprovalRecruiting

Headache

NCT06473597

Q1 2027

Post-ApprovalRecruiting

Migraine

NCT07301008

Phase 3Recruiting

Migraine

NCT06641466

Q2 2027

Phase 2Not yet recruiting

Migraine

NCT06748664

Clinical

Trials by Indication[1]

Migraine39 trials

Efficacy and Safety Trial of Rimegepant for Migraine Prevention in Adults

Completed· Pfizer logo

Pfizer·Phase 2/3·NCT03732638·1,590 enrolled

Efficacy and Safety Study of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects (Japan Only)

Completed· Pfizer logo

Pfizer·Phase 3·NCT05399459·897 enrolled

A Study to Learn About the Long-term Safety of Rimegepant for the Acute Treatment of Migraine in Chinese Participants

Completed· Pfizer logo

Pfizer·Phase 3·NCT05371652·241 enrolled

Show 36 more trials

Rimegepant as Preemptive Treatment for Predictable Trigger-Induced Migraine in Adult Patients in the US

Recruiting·MMedstar Health Research Institute·Phase 4·NCT07301008·60 enrolled

Dose Ranging Study of Rimegepant (BMS-927711) for the Acute Treatment of Migraine

Completed· Pfizer logo

Pfizer·Phase 2·NCT01430442·1,026 enrolled

RimegepAnt effectIvenesS and tolErability as Migraine Preventive Treatment

Recruiting·UUniversity of Florence··NCT06409832·100 enrolled

A Prospective Real World Study of Rimegepant in the Treatment of Migraine

Completed·—··NCT05709106·173 enrolled

Migraine Medication Effects on Urinary Symptoms

Enrolling by invitation·TThe Cleveland Clinic··NCT06212661·200 enrolled

ARISE-A Chinese Real-world Study of Rimegepant for the Acute Treatment of Migraine

Active, not recruiting·—··NCT06439628·3,000 enrolled

Safety and Efficacy in Adult Subjects With Acute Migraines

Completed· Pfizer logo

Pfizer·Phase 3·NCT03237845·1,499 enrolled

Efficacy and Safety Study of Rimegepant for Migraine Prevention in Japanese Subjects (Japan Only)

Completed· Pfizer logo

Pfizer·Phase 3·NCT05399485·496 enrolled

Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of Inadequate Response to Oral Preventive Medications

Completed· Pfizer logo

Pfizer·Phase 4·NCT05518123·658 enrolled

An Open-label, Intermediate Size, Expanded Access Study of BHV-3000 in the Acute Treatment of Migraine

No longer available· Pfizer logo

Pfizer··NCT03934086

Safety and Efficacy Study in Adult Subjects With Acute Migraines

Completed· Pfizer logo

Pfizer·Phase 3·NCT03235479·1,485 enrolled

A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT05127486·580 enrolled

Evaluation of the Efficacy of Diclofenac Potassium and Rimegepant for the Acute Treatment of Migraine

Terminated·DDanish Headache Center·Phase 4·NCT05211154·300 enrolled

A Clinical Trial of Rimegepant for Vestibular Migraine Evaluation: Pre-experiment

Not yet recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 2·NCT06748664·240 enrolled

Acute Migraine Treatment in the ED With Gepants

Recruiting·IIcahn School of Medicine at Mount Sinai·Phase 4·NCT06985342·100 enrolled

The Real-world Study of Rimegepant Treatment in Female Migraine Patients of China

Not yet recruiting·TThe First Affiliated Hospital of Soochow University··NCT06728345·300 enrolled

Safety and Efficacy Trial of BHV3000 (Rimegepant) 75 mg for the Acute Treatment of Migraine

Completed· Pfizer logo

Pfizer·Phase 3·NCT04574362·1,648 enrolled

A Registry Study on Rimegepant for the Treatment of Migraine Participants in Guangdong-Hong Kong-Macao Greater Bay Area

Recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University··NCT06221267·120 enrolled

Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use

Completed· Pfizer logo

Pfizer·Phase 4·NCT05509400·632 enrolled

Safety and Tolerability Study of Daily Dosing Rimegepant in Episodic Migraine Prevention

Completed· Pfizer logo

Pfizer·Phase 4·NCT05207865·441 enrolled

Open Label Safety Study in Acute Treatment of Migraine

Completed· Pfizer logo

Pfizer·Phase 2/3·NCT03266588·3,019 enrolled

Trial in Adult Subjects With Acute Migraines

Completed· Pfizer logo

Pfizer·Phase 3·NCT03461757·1,811 enrolled

Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens

Completed· Pfizer logo

Pfizer·Phase 4·NCT05217927·1,415 enrolled

Predict the Response to Acute Treatment of Migraine With Rimegepant 75 mg

Unknown status·UUniversity of Roma La Sapienza··NCT05888766·20 enrolled

Consistency of Response With Rimegepant in Acute Treatment of Migraine

Active, not recruiting· Pfizer logo

Pfizer··NCT06898047·250 enrolled

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rimegepant for Migraine Prevention in Chinese Participants

Completed· Pfizer logo

Pfizer·Phase 3·NCT05810038·787 enrolled

RETROSPECTIVE COHORT STUDY OF PREGNANCY OUTCOMES IN WOMEN EXPOSED TO RIMEGEPANT DURING PREGNANCY

Active, not recruiting· Pfizer logo

Pfizer··NCT05198245·1 enrolled

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents ≥ 6 to <18 Years of Age

Recruiting· Pfizer logo

Pfizer·Phase 3·NCT05156398·640 enrolled

A PHASE 4, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFECTIVENESS OF REDOSING OF RIMEGEPANT IN PARTICIPANTS 18 YEARS OF AGE OR OLDER FOR THE ACUTE TREATMENT OF MIGRAINE

Recruiting· Pfizer logo

Pfizer·Approved·NCT07609914·400 enrolled

AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, RANDOMIZED, 2-ARM STUDY TO INVESTIGATE THE PREVENTION OF CHRONIC MIGRAINE WITH RIMEGEPANT COMPARED WITH PLACEBO IN PARTICIPANTS 18 YEARS OF AGE OR OLDER

Not yet recruiting· Pfizer logo

Pfizer·Phase 3·NCT07729462·400 enrolled

Phase 3, Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of Rimegepant for the Acute Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to < 18 Years of Age

Recruiting· Pfizer logo

Pfizer·Phase 3·NCT04743141·600 enrolled

Phase 3, Multicenter, Randomized, Double-blind, Group Sequential, Placebo-controlled Study to Assess Efficacy and Safety of Rimegepant for the Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to < 18 Years of Age

Recruiting· Pfizer logo

Pfizer·Phase 3·NCT04649242·2,100 enrolled

A Randomized, Open-Label, Multi-Center Study of Vestibular Migraine Prevention: Rimegepant Versus Flunarizine Non-inferiority Study

Not yet recruiting·SSecond Affiliated Hospital, Zhejiang University, School of Medicine·Phase 2·NCT07751497·400 enrolled

AN INTERVENTIONAL, EFFICACY, AND SAFETY, PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY WITH AN OPEN-LABEL EXTENSION TO INVESTIGATE RIMEGEPANT IN MIGRAINE PREVENTION IN ADOLESCENTS 12 TO LESS THAN 18 YEARS OF AGE WITH CHRONIC MIGRAINE

Active, not recruiting· Pfizer logo

Pfizer·Phase 3·NCT06616194·200 enrolled

AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, PARALLEL GROUP STUDY TO INVESTIGATE INTERMITTENT PREVENTION OF MENSTRUAL MIGRAINE WITH RIMEGEPANT COMPARED WITH PLACEBO IN WOMEN PARTICIPANTS 18 TO 45 YEARS OF AGE

Recruiting· Pfizer logo

Pfizer·Phase 3·NCT06641466·723 enrolled

A Prospective, Open-Label Study Evaluating the Effectiveness of Rimegepant ODT or Zavegepant Nasal Spray for Acute Treatment of Migraine in the Emergency Department

Not yet recruiting·UUniversity of South Florida·Phase 1·NCT07667621·100 enrolled

Pain1 trial

Comparison of Rimegepant and Placebo for Pain in IBS

Completed·MMayo Clinic·Phase 2·NCT06221111·24 enrolled

Trigeminal Neuralgia1 trial

Trial for Treatment Refractory Trigeminal Neuralgia

Terminated· Pfizer logo

Pfizer·Phase 2·NCT03941834·65 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Rimegepant for Acute Dizziness

Not yet recruiting·SShi Tianming·Phase 2/3·NCT07435090·370 enrolled

Effectiveness1 trial

Gepant treAtments: EffectIveNess and tolERability (GAINER)

Recruiting·UUniversity of Florence··NCT05903027·100 enrolled

11 more indications

Temporomandibular Disorders1 trial

Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for Acute Treatment of Temporomandibular Disorders

Terminated· Pfizer logo

Pfizer·Phase 3·NCT05262517·126 enrolled

Psoriasis1 trial

Rimegepant in Moderate Plaque-type Psoriasis

Completed·WWeill Medical College of Cornell University·Phase 2·NCT04629950·41 enrolled

Outcome1 trial

Comparison of Patient-reported Outcomes for Rimegepant and Triptans in the 2023 US National Health and Wellness Survey

Completed· Pfizer logo

Pfizer··NCT06680206·1,395 enrolled

Headache1 trial

A Comparison of Nurtec ODT to Maxalt MLT-ODT in Adult ED Patients With Migraine Headache

Recruiting·AAntonios Likourezos·Phase 4·NCT06473597·80 enrolled

Cluster headache1 trial

Cluster Headache Treatment With Rimegepant

Completed·MMayo Clinic·Phase 2·NCT05264714·20 enrolled

Pancreatic Ductal Adenocarcinoma1 trial

Rimegepant Combined With AG Chemotherapy As First-Line Treatment For Metastatic Pancreatic Ductal Adenocarcinoma

Not yet recruiting·XXiuchao Wang·Phase 1/2·NCT07475234·30 enrolled

Chronic Rhinosinusitis1 trial

Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for the Acute Treatment of Chronic Rhinosinusitis

Completed· Pfizer logo

Pfizer·Phase 3·NCT05248997·261 enrolled

Colorectal Cancer1 trial

Rimegepant Combined With PD-1 in Liver Metastasis Colorectal Cancer Patients

Not yet recruiting·FFudan University·Phase 2·NCT06999252·20 enrolled

Oral Squamous Cell Carcinoma (OSCC)1 trial

A Phase II Randomized Controlled Clinical Trial of Rimegepant-Sensitized Neoadjuvant Chemoimmunotherapy in Patients With Oral/Oropharyngeal Squamous Cell Carcinoma

Not yet recruiting·SShanghai Zhongshan Hospital·Phase 2·NCT07812467·220 enrolled

Endometriosis1 trial

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study Evaluating The Safety And Efficacy Of Rimegepant For Endometriosis-Associated Pain

Not yet recruiting·MMayo Clinic·Phase 2·NCT07795125·132 enrolled

Unspecified1 trial

The R-E-V-I-V-A-L Study

Active, not recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 2·NCT06992674·240 enrolled

Regulatory

FDA Approval Timeline[5]

Feb 27, 2020

NURTEC ODT

NDA NDA212728

Feb 27, 2020

NURTEC ODT

NDA NDA212728

May 27, 2021

NURTEC ODT

NDA NDA212728

Dec 8, 2021

NURTEC ODT

NDA NDA212728

Mar 31, 2022

NURTEC ODT

NDA NDA212728

Apr 11, 2022

NURTEC ODT

NDA NDA212728

Dec 12, 2024

NURTEC ODT

NDA NDA212728

Mar 21, 2025

NURTEC ODT

NDA NDA212728

Aug 1, 2025

NURTEC ODT

NDA NDA212728

Mar 16, 2026

NURTEC ODT

NDA NDA212728

May 8, 2026

NURTEC ODT

NDA NDA212728

Sources

References

[1]
ClinicalTrials.gov — 54 trial records for Rimegepant. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Nurtec drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Rimegepant compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Rimegepant. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA212728). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Nurtec. U.S. Food & Drug Administration.
[7]
PubMed — 1 publication indexed for Rimegepant. U.S. National Library of Medicine.
[8]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: CGRP Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Pfizer

Patent Landscape[6]

Patent Cliff

Feb 25, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8759372Feb 25, 2033

8314117Feb 27, 2034

11083724Mar 25, 2039

Key Publications[7]

Rimegepant for Prevention and Acute Treatment of Migraine: Integrated Analysis

LancetMar 11, 2023DOI: 10.1016/S0140-6736(23)00357-X

Nurtec

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Migraine39 trials

Pain1 trial

Trigeminal Neuralgia1 trial

Efficacy and Safety1 trial

Effectiveness1 trial

Temporomandibular Disorders1 trial

Psoriasis1 trial

Outcome1 trial

Headache1 trial

Cluster headache1 trial

Pancreatic Ductal Adenocarcinoma1 trial

Chronic Rhinosinusitis1 trial

Colorectal Cancer1 trial

Oral Squamous Cell Carcinoma (OSCC)1 trial

Endometriosis1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Key Publications[7]

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