Palvella Therapeutics Inc. (NASDAQ: PVLA) announced the issuance of U.S. Patent No. 12,636,273 exclusively licensed from Yale University for its QTORIN pitavastatin program targeting porokeratosis, according to a company statement.

The patent covers topical administration of HMG-CoA reductase inhibitors, including pitavastatin, for treating porokeratosis and provides protection until 2043. The intellectual property builds on research by Keith Choate, Chair and Professor of Dermatology, Pathology, and Genetics at Yale School of Medicine.

QTORIN pitavastatin is an investigational topical therapy designed to inhibit the mevalonate pathway within affected skin tissue for treating disseminated superficial actinic porokeratosis (DSAP). The company estimates DSAP affects more than 50,000 diagnosed patients in the U.S., with no FDA-approved therapies currently available.

"QTORIN pitavastatin is designed to combine a potent, next-generation statin with Palvella's QTORIN platform to enable pathogenesis-directed inhibition of the mevalonate pathway on-target and directly within DSAP-affected tissue," said Wes Kaupinen, founder and chief executive officer of Palvella Therapeutics.

The therapy combines pitavastatin with Palvella's proprietary QTORIN platform for developing topical treatments for rare skin diseases and vascular malformations. Palvella plans to initiate a Phase 2 clinical trial of QTORIN pitavastatin in DSAP during the second half of 2026.

The company has filed an additional pending application covering the novel QTORIN-derived formulation of pitavastatin and other statins. QTORIN pitavastatin has not been approved by the FDA or any other regulatory agency.