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A pivotal bioequivalence study of midazolam autoinjector

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Trial Profile

A pivotal bioequivalence study of midazolam autoinjector

Status: Planning
Phase of Trial: Phase I

Latest Information Update: 24 Sep 2024

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At a glance

  • Drugs Midazolam (Primary)
  • Indications Status epilepticus
  • Focus Registrational; Therapeutic Use

    • Most Recent Events

    • 23 Sep 2024 According to a Crossject media release, company is working on the final development stages for ZEPIZURE in epileptic crises, including an upcoming 505(b)(2) pivotal bioequivalence study, which the company expects to be the final step for its U.S. NDA, and which follows on from the successful completion of a bioequivalence clinical study in 2022, the results of which were published in May 2024.
    • 18 Jul 2024 According to a Crossject media release, the company announced completion of a new registration batch of ZEPIZURE, at Eurofins facility, which is designated to be the CDMO partner that will ensure fill and finish activities for the deliveries to the U.S. Biomedical Advanced Research and Development Authority (BARDA).
    • 09 Apr 2024 New trial record

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