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A two-month, multi-center, randomized, double-blind, placebo-controlled hepatic safety study of ubrogepant in healthy volunteers

Trial Profile

A two-month, multi-center, randomized, double-blind, placebo-controlled hepatic safety study of ubrogepant in healthy volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 19 Sep 2019

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At a glance

  • Drugs Ubrogepant (Primary)
  • Indications Migraine
  • Focus Adverse reactions
  • Most Recent Events

    • 19 Sep 2019 Safety results (n=516) published in the Cephalalgia.
    • 11 Mar 2019 According to an Allergan media release, based on the results of the safety studies (UBR-MD-04 and 3110-105-002) and from the pivotal studies ACHIEVE I (UBR-MD-01) and ACHIEVE II (UBR-MD-02), the US FDA has company accepted the company's New Drug Application (NDA) for ubrogepant for the acute treatment of migraine in adults. The Prescription Drug User Fee Act (PDUFA) date has been assigned in the fourth quarter of 2019.
    • 25 Oct 2018 New trial record
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