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XS003 (nilotinib)

Chronic Myeloid Leukemia (CML)

NDA SubmittedNDA Submitted 2025

Key Facts

Indication
Chronic Myeloid Leukemia (CML)
Phase
NDA Submitted
Status
NDA Submitted 2025
Company

About Xspray Pharma

Xspray Pharma is a clinical-stage oncology company focused on developing best-in-class, improved versions of marketed Protein Kinase Inhibitor (PKI) drugs. Its core strategy leverages the patented HyNap technology platform to create amorphous solid dispersions that circumvent secondary crystalline patents, enabling earlier market entry post compound patent expiry while offering superior pharmacokinetic profiles. The company is on the cusp of its first commercial launch with Dasynoc in the US, has a pipeline of follow-on candidates, and has established key commercial partnerships to drive market penetration in the multi-billion dollar PKI segment.

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Therapeutic Areas

Other Chronic Myeloid Leukemia (CML) Drugs

DrugCompanyPhase
Scemblix® (asciminib)NovartisApproved / Lifecycle
TERN-701Terns PharmaceuticalsPhase 3
ELVN-001Enliven TherapeuticsPhase 1b
BCR-ABL1 (p210) Monitoring AssaySniper Medical TechnologiesCommercial