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Dasynoc is an optimized, amorphous formulation of dasatinib developed by Xspray Pharma for the treatment of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). It leverages Xspray’s HyNap technology to improve the bioavailability and reduce variability in plasma exposure compared to crystalline dasatinib. This new formulation is less affected by gastric pH changes, minimizing drug-drug interactions with proton pump inhibitors—a common issue with standard dasatinib. Mechanistically, Dasynoc acts as a protein kinase inhibitor targeting BCR-ABL and other kinases involved in leukemogenesis. The FDA has granted orphan drug status for CML, and a resubmitted New Drug Application is under review with a PDUFA date set for October 7, 2025[1][2][5][6][7][8].
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