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Qulipta FDA Approval History

Last updated by Judith Stewart, BPharm on April 27, 2023.

FDA Approved: Yes (First approved September 28, 2021)
Brand name: Qulipta
Generic name: atogepant
Dosage form: Tablets
Company: AbbVie Inc.
Treatment for: Migraine Prevention

Qulipta (atogepant) is an oral, calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent episodic and chronic migraine.



Development timeline for Qulipta

Apr 21, 2023AbbVie Announces Late-Breaking Results from Phase 3 Trial Evaluating Qulipta for the Preventive Treatment of Episodic Migraine Among Patients with Prior Treatment Failure
Apr 17, 2023Approval U.S. FDA Approves Qulipta (atogepant) for Adults With Chronic Migraine
Sep 28, 2021Approval FDA Approves Qulipta (atogepant) Oral CGRP Receptor Antagonist for the Preventive Treatment of Migraine
Mar 30, 2021U.S. FDA Accepts AbbVie's New Drug Application for Atogepant for the Preventive Treatment of Migraine
Jul 29, 2020AbbVie Announces Positive Phase 3 Data for Atogepant in Migraine Prevention
Jun 11, 2018Allergan's Oral CGRP Receptor Antagonist Atogepant Demonstrates Robust Efficacy and Safety in Episodic Migraine Prevention in a Phase 2b/3 Clinical Trial

Further information

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