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A Multicenter, Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations

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Trial Profile

A Multicenter, Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations

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

Latest Information Update: 02 Jul 2026

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At a glance

  • Drugs Sirolimus (Primary)
  • Indications Lymphatic disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms SELVA
  • Sponsors Palvella Therapeutics

Most Recent Events

  • 29 Jun 2026 According to a Palvella Therapeutics media release, the Company has submitted the first module of its rolling New Drug Application (NDA) to the FDA seeking approval of QTORIN 3.9% rapamycin anhydrous gel (QTORIN rapamycin) for the treatment of microcystic lymphatic malformations (microcystic LMs).
  • 22 Jun 2026 According to a Palvella Therapeutics media release, the FDA has granted rolling review for the Companys New Drug Application (NDA) for QTORIN rapamycin for the treatment of microcystic lymphatic malformations (microcystic LMs). Palvella remains on track to complete the NDA submission in the second half of 2026
  • 21 May 2026 Results presented in a Palvella Therapeutics Media Release

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