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Nurtec ODT FDA Approval History

Last updated by Judith Stewart, BPharm on June 1, 2021.

FDA Approved: Yes (First approved February 27, 2020)
Brand name: Nurtec ODT
Generic name: rimegepant
Dosage form: Orally Disintegrating Tablets (ODT)
Company: Biohaven Pharmaceutical Holding Company Ltd.
Treatment for: Migraine; Migraine Prophylaxis

Nurtec ODT (rimegepant) is an orally-dosed calcitonin gene-related peptide (CGRP) receptor antagonist for the acute treatment of migraine with or without aura, and the preventive treatment of episodic migraine, in adults.

Development timeline for Nurtec ODT

DateArticle
Jun 16, 2023Clinical Trial Reaffirms the Efficacy of Emgality in Episodic Migraine Prevention
May 27, 2021Approval FDA Approves Biohaven's Nurtec ODT (rimegepant) for Preventative Treatment of Migraine
Feb 27, 2020Approval FDA Approves Nurtec ODT (rimegepant) for the Acute Treatment of Migraine in Adults
Jul  1, 2019Biohaven Enrolls First Patient in Phase 2 Clinical Trial of Rimegepant, Oral CGRP Receptor Antagonist, for Treatment Refractory Trigeminal Neuralgia
Mar 13, 2019Biohaven Announces Completion of Pre-NDA Meeting With FDA for Oral CGRP Receptor Antagonist Rimegepant
Dec 10, 2018Biohaven Announces Positive Results from Ongoing Rimegepant Long-Term Safety Study
Mar  6, 2018Biohaven Enrolls First Patient In Phase 3 Clinical Trial To Evaluate Rimegepant Zydis® ODT In The Acute Treatment Of Migraine
Nov 27, 2017Biohaven Completes Enrollment in Second Pivotal Phase 3 Clinical Trial of Oral CGRP-Receptor Antagonist Rimegepant
Jul 24, 2017Biohaven Enrolls First Patient In Pivotal Phase 3 Clinical Trial of Oral Rimegepant for the Acute Treatment of Migraine

Further information

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