Palvella Therapeutics Announces European Patent for Rapamycin Gel

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Palvella Therapeutics, a clinical-stage biopharmaceutical company, announced that the European Patent Office has issued a patent covering anhydrous topical compositions and methods of use for QTORIN™ rapamycin, the company's lead product candidate. The patent provides protection for QTORIN™ rapamycin, which is being developed for the treatment of microcystic lymphatic malformations, venous malformations, and other diseases associated with the mTOR pathway, until 2038.

Why it matters

The issuance of this European patent represents an important milestone in expanding Palvella's global intellectual property protection for QTORIN™ rapamycin. The patent complements the company's existing patents in the United States, Japan, Australia, and other territories, strengthening its exclusivity strategy. Additionally, QTORIN™ rapamycin has been granted Orphan Drug Designation for the treatment of microcystic lymphatic malformations in the European Union, potentially providing 10 years of market exclusivity upon approval.

The details

The patented compositions relate to Palvella's proprietary QTORIN™ anhydrous gel formulation, which is designed to locally inhibit the mTOR pathway within affected pathogenic skin tissue while minimizing systemic exposure. The patent includes composition-of-matter and method-of-use claims covering QTORIN™ rapamycin for the treatment of a range of diseases associated with dysregulation of the mTOR pathway, including microcystic lymphatic malformations, venous malformations, and clinically significant angiokeratomas.

• The European Patent Office issued European Patent No. 3565520 on March 16, 2026.

What they’re saying

What’s next

Palvella is currently advancing QTORIN™ rapamycin across multiple serious, rare skin diseases and vascular malformations for which there are no FDA-approved therapies, including microcystic lymphatic malformations, cutaneous venous malformations, clinically significant angiokeratomas, and a fourth target clinical indication which the company anticipates announcing in the second half of 2026.