QTORIN rapamycin 3.9 percent gel

QTORIN rapamycin is an investigational topical sirolimus formulation. The sponsor announced completion of its rolling NDA submission on August 31, 2026. Submission does not establish regulatory approval.

The available phase 3 evidence describes improvement during a 24-week treatment period in a single-arm study of superficial/cutaneous microcystic lymphatic malformations. The study excluded participants with severe systemic symptoms requiring systemic therapy. These findings do not establish comparative efficacy against surgery, sclerotherapy, other topical sirolimus formulations, or systemic treatment. The pricing projection does not establish cost effectiveness or budget impact.