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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: 08 Sep 2026

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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

  • 31 Aug 2026 According to a Palvella Therapeutics media release, the Company has completed the rolling submission of its NDA to FDA for QTORIN rapamycin for the treatment of microcystic lymphatic malformations (microcystic LMs). The NDA includes SELVA study results and Phase 2 clinical results that supported FDA's decision to Breakthrough Therapy designation, as well as published literature and other evidence regarding the clinical use of off-label rapamycin in microcystic LMs.
  • 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).

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