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SM-020 is a first-in-class, patient-applied topical small molecule inhibitor of the serine/threonine protein kinase AKT (also known as protein kinase B), developed by DermBiont. It is formulated as a gel for topical application and is being investigated primarily for the treatment of locally advanced basal cell carcinoma (laBCC) and prevention of basal cell carcinoma (BCC) in patients with Gorlin Syndrome, both orphan oncology indications. SM-020 selectively inhibits AKT activity, thereby blocking the PI3K/AKT signaling pathway—a central node in tumorigenesis pathways—leading to increased apoptosis and reduced proliferation of tumor cells. The drug has also been studied for seborrheic keratosis (SK), dermatosis papulosa nigra, squamous cell carcinoma in situ, and other non-melanoma skin cancers. Clinical trials have demonstrated that SM-020 induces apoptosis specifically in SK cells without cytotoxicity to healthy tissue and shows high potency against BCC cells with favorable tolerability profiles[1][2][4][5][6][7][8].
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