Palvella Therapeutics (Nasdaq: PVLA), based in Wayne, Pennsylvania, has received US Patent No. 12,636,273 from the United States Patent and Trademark Office, exclusively licensed from Yale University, covering topical administration of HMG-CoA reductase inhibitors — including pitavastatin — for the treatment of porokeratosis. The QTORIN pitavastatin patent extends protection into 2043 and anchors Palvella’s pitavastatin intellectual property position ahead of a planned Phase II trial in disseminated superficial actinic porokeratosis, or DSAP, targeted for the second half of 2026.
DSAP is a rare, premalignant genetic skin disorder with an estimated 50,000 or more diagnosed patients in the US and no FDA-approved therapies. The condition is driven by loss-of-function variants in mevalonate pathway genes, linking disease biology directly to the cholesterol and isoprenoid biosynthesis cascade that statins inhibit.
The mevalonate pathway, regulated upstream by HMG-CoA reductase, produces cholesterol and isoprenoid intermediates essential for normal keratinocyte function. Pathogenic variants in genes including MVK and PMVK, which encode enzymes downstream in this pathway, have been reported in porokeratosis patients, providing a genetic rationale for pathway-directed intervention. Palvella’s approach uses its proprietary QTORIN platform to deliver pitavastatin — a next-generation statin with high potency relative to earlier agents — topically and directly into affected skin tissue, seeking local pathway modulation without reliance on systemic exposure.
The Yale-licensed patent, built on work by Keith Choate, MD, PhD, Chair and Professor of Dermatology, Pathology, and Genetics at Yale School of Medicine, covers the class of HMG-CoA reductase inhibitors applied topically for porokeratosis, not solely pitavastatin. That class-level breadth potentially raises the barrier for competing topical statin formulations seeking to enter the DSAP space without licensing. Palvella has also filed a separate pending application covering the novel QTORIN-derived formulation of pitavastatin and other statins, adding a second layer to the pitavastatin intellectual property estate.