Evaluating a new treatment for microcystic lymphatic malformations
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-11104574 · Data updated 2026-11-12
This study is testing a new gel called PTX-022 to see if it can safely help people with microcystic lymphatic malformations, a rare condition that affects the lymphatic system, and it's looking for participants to see how well it works and if there are any side effects.
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 | 2024 |
| Award (this year) | $479,560 |
| NIH project number | 1R01FD008196-01A1 |
| Project ID | NIH-11104574 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for this research are individuals diagnosed with microcystic lymphatic malformations, particularly those experiencing significant symptoms.
✕Less likely to help
Patients without a diagnosis of microcystic lymphatic malformations or those with other lymphatic disorders may not benefit from this research.
What this research studies
This research investigates the safety and effectiveness of a topical gel called PTX-022 for treating microcystic lymphatic malformations, a rare and chronic condition affecting the lymphatic system. Patients will be enrolled in a multicenter, phase 3 trial where they will receive the treatment and be monitored for improvements in their symptoms and overall health. The study aims to provide the first FDA-approved therapy for this debilitating condition, which currently has no approved treatments. Participants will be closely observed to assess any side effects and the gel's impact on their condition.
Why it matters
Potential benefit: If successful, this research could lead to the first effective treatment for patients suffering from microcystic lymphatic malformations.
How similar studies have gone: Preliminary studies have shown some benefit of oral sirolimus in treating microcystic lymphatic malformations, indicating potential for success with this topical formulation.
Where this research is happening
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Palvella Therapeutics, INC.
Wayne, United States Active
Researchers
- Principal investigator: Martini, Jeff — Palvella Therapeutics, INC.
- Study coordinator: Martini, Jeff
Related research
Other NIH-funded projects on the same topics.
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PTX-022 ointment gel for rare microcystic lymphatic malformations (LM)
A new topical gel (PTX-022) is being tested to help people with a rare, lifelong skin and lymphatic condition called microcystic LM.
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Topical sirolimus (PTX-022) for microcystic lymphatic malformations
This project offers a topical sirolimus gel (PTX-022) for people with microcystic lymphatic malformations to try to reduce leaking, infections, and other skin symptoms while checking safety.
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.