Drug intelligence / Profile preview

Dasynoc

Development stage
Phase 1
Lead developer
Xspray Pharma
Modality
Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, Allosteric Modulators → Classical Binding Small Molecules → Small Molecules, Covalent Small Molecules → Small Molecules
Administration
Oral
01

Overview

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].

Brand names
Dasynoc
Other names
dasatinib amorphousamorphous dasatinib
02

Targets

PDGFRB (Platelet-derived growth factor receptor beta)ABL1 (ABL proto-oncogene 1, non-receptor tyrosine kinase)SFK (SRC family kinases)

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