PTX-022 ointment gel for rare microcystic lymphatic malformations (LM)
Official title: SELVA: A Multicenter, Phase 3 Baseline-Controlled Study Evaluating the Safety and Efficacy of PTX-022 in the Treatment of Microcystic Lymphatic Malformations
Funded at Palvella Therapeutics, INC. · NIH-11403007 · Data updated 2026-11-12
A new topical gel (PTX-022) is being tested to help people with a rare, lifelong skin and lymphatic condition called microcystic LM.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Palvella Therapeutics, INC. NIH-funded |
| Lab location | 1 site (Wayne, United States) |
| Project start | September 20, 2024 |
| Project end | August 31, 2028 |
| Funding year | 2026 |
| Award (this year) | $484,481 |
| NIH project number | 5R01FD008196-03 |
| Project ID | NIH-11403007 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal participants are individuals with diagnosed microcystic lymphatic malformations, ideally presenting in the dermis with potential epidermal involvement.
✕Less likely to help
Some participants may not experience improvement and could experience gel-related skin effects.
What this research studies
This project tests the safety and effectiveness of a topical sirolimus gel in multiple centers for treating microcystic lymphatic malformations. It aims to provide a targeted therapy for a disease with limited approved options and significant morbidity. Study activities include applying the gel and monitoring both safety and disease response over time in participants with the condition.
Why it matters
Potential benefit: If successful, patients may experience better control of symptoms and fewer complications from microcystic LM.
How similar studies have gone: Preliminary data with oral sirolimus showed some benefit, and topical sirolimus has shown signals of activity in this condition.
Where this research is happening
-
Palvella Therapeutics, INC.
Wayne, United States Active
Researchers
- Principal investigator: Martini, Jeff — Palvella Therapeutics, INC.
- Study coordinator: Martini, Jeff
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.