The FDA has accepted Xspray Pharma’s resubmitted New Drug Application (NDA) for Dasynoc®, developed as an improved formulation of dasatinib (Sprycel®) for treating chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). The agency has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 25, 2026.
Dasynoc was developed using Xspray’s proprietary HyNap™ technology platform, designed to deliver more consistent absorption and bioavailability independent of stomach pH. According to the company, the formulation enables administration at approximately 30% lower dosage compared to the reference product.
The NDA resubmission follows the FDA’s earlier request for additional information and risk mitigation data related to potential medication errors. Xspray stated it has completed and submitted the required studies per agency guidelines, addressing the previous deficiencies identified by the regulator.
Xspray plans to launch Dasynoc alongside XS003 (nilotinib) during the second half of 2026, pending FDA approval. Both candidates target similar hematologic cancer indications, representing a combined potential U.S. market valued at roughly USD 2.7 billion.
The company also noted that previously reported GMP-related observations at its third-party manufacturing facility are being addressed by the new owner, Benta Group, in coordination with regulatory authorities. Xspray’s ongoing activities include further clinical collaborations and launch preparations to establish HyNap™ as a platform for improved oral oncology formulations.
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