WAYNE, PA — Palvella Therapeutics Inc. (Nasdaq: PVLA) said the European Patent Office has granted a patent covering its lead product candidate QTORIN 3.9% rapamycin gel, extending intellectual property protection in Europe through 2038.
The company announced the patent issuance, European Patent No. 3565520, which covers anhydrous topical formulations of rapamycin and methods of use for treating microcystic lymphatic malformations, venous malformations and other conditions linked to dysregulation of the mTOR pathway.
Palvella said the patent adds to its existing intellectual property portfolio in the United States, Japan, Australia and other regions.
“Issuance of this European patent represents an important milestone in expanding our global intellectual property protection for QTORIN rapamycin,” CEO Wes Kaupinen said.
The company’s QTORIN formulation is designed to deliver rapamycin directly to affected skin tissue to inhibit the mTOR pathway while limiting systemic exposure, according to the release.
Palvella is developing the therapy for several rare skin diseases and vascular malformations, including microcystic lymphatic malformations, for which there are currently no approved treatments in the European Union.
The therapy has received Orphan Drug Designation from the European Medicines Agency for microcystic lymphatic malformations, which could provide up to 10 years of market exclusivity in the EU if approved.
Palvella said it is also studying QTORIN rapamycin for additional conditions, including cutaneous venous malformations and angiokeratomas, and expects to announce another target indication in the second half of 2026.
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