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Also known as QTORIN 3.9% rapamycin anhydrous gel, QTORIN 3.9% rapamycin anhydrous, QTORIN 3.9% Rapamycin Anhydrous Gel, QTORIN 3.9% Rapamycin Anhydrous
QTORIN rapamycin · 3 trials · 3 indications
A multi-point scale with higher values indicating improvement.
| Arm | Type | Description |
|---|---|---|
| Active | EXPERIMENTAL | - |
| Vehicle | PLACEBO_COMPARATOR | - |
| Single-arm, open-label | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| QTORIN 3.9% Rapamycin Anhydrous Gel | DRUG | QTORIN 3.9% Rapamycin Anhydrous Gel |
| Vehicle | DRUG | Matching vehicle (QTORIN anyhydrous gel) |
Key Inclusion Criteria: * Participant must be at least 3 years of age at time of consent/assent * Participant must have a clinically confirmed superficial/cutaneous microcystic lymphatic malformation Key Exclusion Criteria: * Participants who have vascular malformations that interfere with evalua...
QTORIN rapamycin is an investigational topical small molecule therapy developed by Palvella Therapeutics, Inc. (PVLA). It is being studied for dermatologic conditions including cutaneous venous malformations, microcystic lymphatic malformation, and pachyonychia congenita. It is formulated as a 3.9% rapamycin anhydrous gel applied directly to the skin.
QTORIN rapamycin is being developed to treat cutaneous venous malformations, microcystic lymphatic malformation, and pachyonychia congenita. These are dermatologic conditions involving vascular and lymphatic malformations and a rare genetic skin disorder. The drug remains investigational and has not been approved for commercial use.
QTORIN rapamycin is developed by Palvella Therapeutics, Inc., which trades under the ticker PVLA. The company is advancing the topical rapamycin gel across multiple rare dermatologic indications and holds Fast Track, Breakthrough Therapy, and Orphan Drug designations from the FDA for the program.
QTORIN rapamycin is in clinical development, with Phase 2 and Phase 3 studies conducted across its indications. A Phase 3 trial in pachyonychia congenita has completed, and Phase 3 and Phase 2 trials in microcystic lymphatic malformation and cutaneous venous malformations are active. It is investigational and not FDA approved.
QTORIN rapamycin has been studied in NCT05180708, a completed Phase 3 trial in pachyonychia congenita with 87 participants, and NCT06239480, an active Phase 3 trial in microcystic lymphatic malformation. A Phase 2 trial, NCT06653842, is evaluating the gel in cutaneous venous malformations. All trials are based in the United States, with the pachyonychia congenita study also including the United Kingdom.
Yes. QTORIN rapamycin is also known as QTORIN 3.9% rapamycin anhydrous gel, QTORIN 3.9% rapamycin anhydrous, and QTORIN 3.9% Rapamycin Anhydrous Gel. These names refer to the same investigational topical formulation developed by Palvella Therapeutics for dermatologic indications.