CLL442

CLL442 is a small molecule topical drug developed by Novartis for the treatment of cutaneous squamous cell carcinoma in situ (SCCis). It is formulated as a cream and was investigated in phase 1/2 trials for safety, tolerability, and efficacy when applied twice daily to lesions. Mechanistically, CLL442 acts as an inhibitor of phosphatidylinositol 3 kinase alpha (PI3Kα) and the serine/threonine-protein kinase mTOR, targeting the PI3K/mTOR signaling pathway, which plays a role in cell growth and proliferation. Phase 1/2 clinical studies concluded that while CLL442 was safe and well tolerated, it did not meet primary efficacy endpoints for lesion reduction or clearance in SCCis.