Nilopki

Nilopki (XS004) is an amorphous solid dispersion formulation of nilotinib, a second-generation BCR-ABL tyrosine kinase inhibitor, developed by Xspray Pharma. Utilizing the proprietary HyDRES technology, Nilopki is designed to improve the solubility and bioavailability of nilotinib compared to the reference crystalline product (Tasigna). This improved profile aims to eliminate the significant food effect and gastric pH dependency associated with nilotinib, potentially allowing for more flexible dosing and improved patient compliance. Nilopki is primarily indicated for the treatment of Chronic Myeloid Leukemia (CML). Xspray Pharma has submitted a New Drug Application (NDA) for Nilopki via the 505(b)(2) regulatory pathway, with a PDUFA date of June 18, 2026. The drug has also been granted Orphan Drug Designation by the FDA.

Brand names

Nilopki

Other names

XS004XS-004XS 004nilotinib amorphous