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.
- Episodic migraine is characterized by 0 to 14 headache days per month, and chronic migraine is characterized by 15 or more headache days per month.
- Qulipta contains atogepant, which is a calcitonin gene-related peptide (CGRP) receptor antagonist that 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 monoclonal antibody CGRP antagonists approved for the preventive treatment of migraine are larger molecules that need to be administered via injection.
- Atogepant has a high potency and a long half-life making it suitable for preventive treatment of migraine. The gepants with a shorter half-life are used for the acute treatment of migraine.
- Qulipta tablets are taken orally once daily with or without food.
- Warnings and precautions associated with Qulipta include severe hypersensitivity reactions which can occur days after administration.
- Common adverse reactions include nausea, constipation, and fatigue.
Development timeline for Qulipta
Further information
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