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
Latest Information Update: 27 Jun 2025
At a glance
- Drugs Sirolimus (Primary)
- Indications Lymphatic disorders
- Focus Registrational; Therapeutic Use
- Acronyms SELVA
- Sponsors Palvella Therapeutics
Most Recent Events
- 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
- 23 Jun 2025 Status changed from recruiting to active, no longer recruiting as per Palvella Therapeutics media release
- 09 Jun 2025 According to a Palvella Therapeutics media release, the company received the initial proceeds from a previously announced grant from the FDA Office of Orphan Products Development. The grant supports the Companys ongoing Phase 3 SELVA trial