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A Phase II bunionectomy trial of otenaproxesul

Trial Profile

A Phase II bunionectomy trial of otenaproxesul

Status: Suspended
Phase of Trial: Phase II

Latest Information Update: 11 Apr 2024

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At a glance

  • Drugs Otenaproxesul (Primary)
  • Indications Postoperative pain
  • Focus Adverse reactions
  • Sponsors Antibe Therapeutics
  • Most Recent Events

    • 08 Apr 2024 According to an Antibe Therapeutics media release, company will seek a further extension of the Stay Period in order to be able to continue engaging with the U.S. Food and Drug Administration with respect to the previously announced hold on the Company's planned Phase II trial and to determine the appropriate next steps.
    • 01 Apr 2024 According to an Antibe Therapeutics media release, company announced that it received verbal notice on March 28, 2024 from the U.S. Food and Drug Administration (FDA) that otenaproxesul has been placed on clinical hold, postponing the initiation of the planned Phase II trial. Antibe expects to receive a formal Clinical Hold Letter from the FDA within 30 days outlining their rationale and further details.
    • 01 Apr 2024 Status changed to suspended, according to an Antibe Therapeutics media release.
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