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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

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: 21 May 2025

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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

  • 15 May 2025 According to Palvella Therapeutics media release, results from this study published in the Journal of Vascular Anomalies (JoVA).
  • 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).

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