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: 03 Feb 2026

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At a glance

09 Jan 2026 According to a Palvella Therapeutics media release, company requested a Preliminary Breakthrough Therapy Designation Advice meeting with the U.S. Food and Drug Administration, anticipated in the first quarter of 2026
15 Dec 2025 According to a Palvella Therapeutics media release, based on results from this study company is planning for near-term discussions with FDA regarding the potential for Breakthrough Therapy Designation.
15 Dec 2025 According to a Palvella Therapeutics media release, company will host a conference call and live audiovisual webcast on 15 Dec 2025 to discuss topline results from this study.

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