Nurtec ODT (Rimegepant)

Brand Name

Nurtec ODT

Generic Name

Rimegepant

View Brand Information

FDA approval date: March 05, 2020

Classification: Calcitonin Gene-related Peptide Receptor Antagonist

Form: Tablet

What is Nurtec ODT (Rimegepant)?

NURTEC ODT is a calcitonin gene-related peptide receptor antagonist indicated for the: acute treatment of migraine with or without aura in adults.

Approved To Treat

Migraine

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Related Clinical Trials

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

Who is this study for: Children and adolescents with episodic migraine

Enrollment Status: Recruiting

Publish Date: August 24, 2026

Intervention Type: Drug

Study Drug: Rimegepant

Study Phase: Phase 3

Summary: The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to \<18 years with episodic migraine.

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

Enrollment Status: Recruiting

Publish Date: August 24, 2026

Intervention Type: Drug

Study Phase: Phase 4

Summary: Acute treatments for migraine may not provide sufficient pain relief after an initial dose, and a second dose of a given medication may be needed to fully abort an attack. International Headache Society (IHS) global practice recommendations for the Acute Treatment of Migraine suggest a second dose of the same medication within the recommended dose limit in people with headache relapse after succes...

AN OPEN-LABEL MULTICENTER STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF RIMEGEPANT 75 MG ODT FOR ACUTE TREATMENT OF MIGRAINE IN ADULT PARTICIPANTS IN INDIA WITH PREVIOUS INSUFFICIENT RESPONSE TO TRIPTANS

Enrollment Status: Recruiting

Publish Date: August 21, 2026

Intervention Type: Drug

Study Phase: Phase 4

Summary: This is a multicenter, single-arm, open-label Phase 4 study evaluating the safety and tolerability of rimegepant 75 mg orally disintegrating tablet (ODT) for the acute treatment of migraine (with or without aura) in adult patients in India who have had an insufficient response, intolerance, or contraindication to triptans. It will enroll approximately 60 participants.

View All Clinical Trials

Related Latest Advances

Systematic Review of Pharmacologic Treatment for Migraine Prevention in Adults: Report of the AAN Guidelines Subcommittee and the American Headache Society.

Journal: Neurology

Published: August 31, 2026

Reply to: Baseline severity is not treatment timing in acute rimegepant treatment for vestibular migraine.

Journal: Cephalalgia : an international journal of headache

Published: August 19, 2026

Baseline severity is not treatment timing in acute rimegepant treatment for vestibular migraine.

Journal: Cephalalgia : an international journal of headache

Published: August 19, 2026

View All Latest Advances

Brand Information

NURTEC ODT (rimegepant sulfate)

1DOSAGE FORMS AND STRENGTHS

Orally disintegrating tablets: white to off-white, circular, and debossed with the symbol

2CONTRAINDICATIONS

NURTEC ODT is contraindicated in patients with a history of hypersensitivity reaction to rimegepant, NURTEC ODT, or any of its components.Reactions have included anaphylaxis and delayedserious hypersensitivity

3ADVERSE REACTIONS

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:

Hypersensitivity Reactions
Hypertension
Raynaud’s Phenomenon

3.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

3.2Postmarketing Experience

The following adverse reactions have been identified during postapproval use of NURTEC ODT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune System Disorders: Hypersensitivity (e.g., anaphylaxis) [see

Vascular Disorders: Hypertension [see , Raynaud’s phenomenon [see

4OVERDOSAGE

There is limited clinical experience with NURTEC ODT overdosage. Treatment of an overdose of NURTEC ODT should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. No specific antidote for the treatment of rimegepant overdose is available. Rimegepant is unlikely to be significantly removed by dialysis because of high serum protein binding

5DESCRIPTION

NURTEC ODT contains rimegepant sulfate, a calcitonin gene-related peptide receptor antagonist. Rimegepant sulfate is described chemically as (5S,6S,9R)-5-amino-6-(2,3-difluorophenyl)-6,7,8,9-tetrahydro-5H-cyclohepta[b]pyridin-9-yl 4-(2-oxo-2,3-dihydro-1H-imidazo[4,5-b]pyridin-1-yl)-1-piperidinecarboxylate hemisulfate sesquihydrate and its structural formula is:

Its empirical formula is C

NURTEC ODT (orally disintegrating tablets) is for sublingual or oral use and contains 85.7 mg rimegepant sulfate, equivalent to 75 mg rimegepant free base, and the following inactive ingredients: benzyl alcohol, eucalyptol, gelatin, limonene, mannitol, menthol, menthone, menthyl acetate, sucralose, and vanillin.

6PATIENT COUNSELING INFORMATION

Advise patients to read the FDA-approved patient labeling (Patient Information).

7PRINCIPAL DISPLAY PANEL