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Qulipta FDA Approval History

Last updated by Judith Stewart, BPharm on Oct 5, 2021.

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 indicated for the preventive treatment of episodic migraine in adults.

  • Qulipta works by blocking CGRP receptors to prevent migraine. CGRP and CGRP receptors are expressed in regions of the nervous system associated with migraine pathophysiology.
  • Atogepant belongs to the gepant class of CGRP receptor antagonists which are small molecules intended for oral administration. The larger molecule monoclonal antibody CGRP antagonists need to be administered via injection.
  • Qulipta tablets are taken orally once daily with or without food.
  • Common adverse reactions include nausea, constipation, and fatigue.



Development timeline for Qulipta

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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