Palvella says Phase 3 SELVA substudy shows QTORIN rapamycin exposure at least 40-fold below oral sirolimus
PVLA•Palvella said a Phase 3 SELVA substudy found systemic exposure to topical QTORIN rapamycin was at least 40-fold below oral sirolimus. The company also cited a claims review estimating 154,986 diagnosed DSAP patients and said a DSAP Phase 2 study is expected in Q4 2026.
1. Study and market findings
Palvella Therapeutics announced three posters with new Phase 3 SELVA and market-analysis data presented at Fall Clinical Dermatology 2026. SELVA interview findings indicated patients, caregivers and clinicians reported meaningful symptom improvement with QTORIN rapamycin, with high satisfaction. A maximal-use substudy found systemic exposure with the topical gel was at least 40-fold below oral sirolimus and described exposure as low and steady.
2. Pipeline updates
A U.S. claims review estimated 154,986 diagnosed patients with disseminated superficial actinic porokeratosis (DSAP). Palvella said an FDA NDA filing for QTORIN rapamycin in microcystic lymphatic malformations has been submitted and a DSAP Phase 2 study is expected in Q4 2026.
