Palvella Secures Patent for Topical Pitavastatin, Plans Phase 2 DSAP Trial
PVLA•Palvella obtained U.S. Patent No. 12,636,273 for topical pitavastatin in porokeratosis, securing IP protection through 2043. The company plans a Phase 2 trial of QTORIN™ pitavastatin in over 50,000 U.S. patients with DSAP in second half of 2026.
1. Patent Issuance and Coverage
Palvella announced issuance of U.S. Patent No. 12,636,273, exclusively licensed from Yale, covering topical administration of HMG-CoA reductase inhibitors including pitavastatin for porokeratosis. This patent secures intellectual property protection for the QTORIN™ pitavastatin program through 2043.
2. Targeting DSAP Patient Population
The issued patent specifically covers treatment of disseminated superficial actinic porokeratosis (DSAP), a rare premalignant genetic skin disease affecting over 50,000 diagnosed patients in the U.S. with no approved therapies.
3. Phase 2 Trial Timeline
Palvella plans to initiate a Phase 2 clinical trial of QTORIN™ pitavastatin in DSAP in the second half of 2026, advancing its pathogenesis-directed approach to topical mevalonate pathway inhibition.
