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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 Oct 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

  • 14 Aug 2025 According to Palvella Therapeutics media release, the company reviewed Phase 2 results in an oral presentation highlighting QTORIN rapamycin for the treatment of microcystic LMs, presented by Amy Paller, M.S., M.D., at the 15th World Congress of Pediatric Dermatology.
  • 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.

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