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A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 (Sirolimus) Topical Gel 3.9% in the Treatment of Cutaneous Venous Malformations

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Trial Profile

A Phase 2, Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 (Sirolimus) Topical Gel 3.9% in the Treatment of Cutaneous Venous Malformations

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 08 Sep 2026

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At a glance

  • Drugs Sirolimus (Primary)
  • Indications Vascular malformations
  • Focus Adverse reactions
  • Acronyms TOIVA
  • 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.
  • 21 May 2026 Results presented in a Palvella Therapeutics Media Release.
  • 20 May 2026 According to a Palvella Therapeutics media release, data from this study presented at the International Society for the Study of Vascular Anomalies (ISSVA) World Congress 2026 in Philadelphia, PA.

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