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: 05 Mar 2026

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At a glance

24 Feb 2026 According to a Palvella Therapeutics media release, Primary endpoint Clinician Global Impression of Change (CGI-C)) has been met.
24 Feb 2026 According to a Palvella Therapeutics media release, Palvella plans to submit a New Drug Application to FDA in the second half of 2026 with potential U.S. approval for QTORIN rapamycin in the first half of 2027.
24 Feb 2026 Results presented in the Palvella Therapeutics Media Release

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