Xspray Pharma AB announced that XS003, its amorphous, non-crystalline formulation of nilotinib, has demonstrated bioavailability within the 80-125% range to TASIGNA following oral administration with significantly lower dose. This is the second of three announced amorphous PKIs under development by Xspray using the HyNap platform to address critical limitations with currently marketed crystalline formulations. XS003 demonstrated the results in a comparative bioavailability study involving healthy volunteers.

It is Xspray's second product candidate developed using the HyNap technology. XS003 is being developed under the regulatory 505(b)(2) NDA process, which streamlines the approval process, and XS003 is expected to be submitted to the FDA for approval in the second half of 2024. In 2020, XS003 received orphan drug status by the FDA for the treatment of CML.

Worldwide sales for TASIGNA approached $2.0 billion in 2022.