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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: 13 Nov 2025

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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

  • 13 Oct 2025 According to a Palvella Therapeutics media release, company received the second year of funding under its FDA Office of Orphan Products Development grant.The grant provides up to $2.6 million in non-dilutive funding over its full 4-year term and supports Palvella's ongoing Phase 3 SELVA trial
  • 07 Aug 2025 Last checked against ClinicalTrials.gov: US National Institutes of Health record.
  • 23 Jun 2025 According to a Palvella Therapeutics media release, the company remain on track to deliver top-line Phase 3 data in the first quarter of 2026 to support a planned NDA submission (planned for the second half of 2026) for QTORIN rapamycin as the first targeted therapy for this chronically debilitating disease

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