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Updated: Dec 29, 2025

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Ubrogepant: First Approval.

Lesley J Scott1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

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Summary
This summary is machine-generated.

Ubrogepant (Ubrelvy™) is a new oral CGRP antagonist for acute migraine treatment. It received US approval in December 2019, marking a significant milestone for migraine therapy.

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Area of Science:

  • Pharmacology
  • Neurology
  • Drug Development

Background:

  • Migraine is a prevalent neurological disorder.
  • Current acute treatments have limitations.
  • Calcitonin gene-related peptide (CGRP) antagonists represent a novel therapeutic class.

Purpose of the Study:

  • To summarize the development milestones of ubrogepant.
  • To highlight the pathway to its first global approval for acute migraine treatment.

Main Methods:

  • Review of preclinical and clinical development data.
  • Analysis of regulatory submission and approval process.

Main Results:

  • Ubrogepant, a selective CGRP antagonist, was developed.
  • The drug demonstrated efficacy in clinical trials for acute migraine.
  • Ubrogepant received US FDA approval in December 2019.

Conclusions:

  • Ubrogepant offers a new oral treatment option for acute migraine.
  • The development highlights advancements in CGRP antagonist therapy.
  • The approval signifies a major step in managing migraine attacks.