Drug intelligence / Profile preview

Danziten

Development stage
Approved
Lead developer
Azurity Pharmaceuticals
Modality
Small Molecules
Administration
Oral
01

Overview

Danziten (nilotinib) is a small molecule tyrosine kinase inhibitor (TKI) developed by Azurity Pharmaceuticals following its acquisition of Arbor Pharmaceuticals. Approved by the FDA in November 2024, it is indicated for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase, as well as those in chronic or accelerated phase who are resistant or intolerant to prior therapy, including imatinib. Danziten is a re-engineered formulation of nilotinib designed to eliminate the mealtime restrictions associated with earlier nilotinib products like Tasigna. By providing consistent bioavailability regardless of food intake, it removes the requirement for patients to take the medication in a fasted state, potentially improving adherence and quality of life for CML patients.

Brand names
Danziten
Other names
nilotinib
02

Targets

ABL1 (ABL proto-oncogene 1, non-receptor tyrosine kinase)KIT (c-KIT proto-oncogene receptor tyrosine kinase)PDGFRA (Platelet-derived growth factor receptor alpha)

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