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A Multicenter, Phase 2, Open-Label Study Evaluating The Safety And Efficacy of Sirolimus 3.9% Topical Gel (PTX-022) In The Treatment of Microcystic Lymphatic Malformations

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Trial Profile

A Multicenter, Phase 2, Open-Label Study Evaluating The Safety And Efficacy of Sirolimus 3.9% Topical Gel (PTX-022) In The Treatment of Microcystic Lymphatic Malformations

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 03 Sep 2024

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At a glance

  • Drugs Sirolimus (Primary)
  • Indications Lymphatic disorders
  • Focus Adverse reactions; Proof of concept
  • Sponsors Palvella Therapeutics

    • Most Recent Events

    • 29 Aug 2024 Status changed from active, no longer recruiting to completed.
    • 16 Nov 2023 According to Palvella Therapeutics media release, based on results from this trial the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to QTORIN rapamycin for the treatment of Microcystic Lymphatic Malformations (Microcystic LMs).
    • 13 Mar 2023 According to Palvella Therapeutics media release, James Treat, MD is a consultant for Palvella Therapeutics and a study investigator for this trial.

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