DANZITEN (nilotinib tartrate)
Danziten is a kinase inhibitor that treats adults with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML). It is used for patients who are newly diagnosed in the chronic phase of the disease. This medication also helps patients with chronic or accelerated phase Ph+ CML who have developed resistance or intolerance to previous therapy that included imatinib.
How DANZITEN Works
This drug works by binding to and stabilizing the inactive form of the BCR-ABL kinase, which prevents the proliferation of leukemic cells. By targeting this specific protein, it can overcome many genetic mutations that typically cause resistance to other therapies like imatinib.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2024-11-07
- Patent Cliff
- 2040
- Routes
- ORAL
- Dosage Forms
- TABLET
DANZITEN Approval History
What DANZITEN Treats
1 indicationsDANZITEN is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Myeloid Leukemia
DANZITEN Boxed Warning
QT PROLONGATION and SUDDEN DEATHS • Nilotinib prolongs the QT interval. Prior to DANZITEN administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies [ see Warnings and Precautions ( 5.3 ) ]. Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments [ see Warnings and Precautions ( 5.3 , 5.4 , 5.8 , 5.12 ) ]. • Sudden deaths have been reported in patients receiving nilotinib [ s...
WARNING: QT PROLONGATION and SUDDEN DEATHS • Nilotinib prolongs the QT interval. Prior to DANZITEN administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies [ see Warnings and Precautions ( 5.3 ) ]. Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments [ see Warnings and Precautions ( 5.3 , 5.4 , 5.8 , 5.12 ) ]. • Sudden deaths have been reported in patients receiving nilotinib [ see Warnings and Precautions ( 5.4 ) ]. Do not administer DANZITEN tablets to patients with hypokalemia, hypomagnesemia, or long QT syndrome [ see Contraindications (4), Warnings and Precautions ( 5.3 ) ]. • Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors [ see Drug Interactions ( 7.1 , 7.2 ) ]. WARNING: QT PROLONGATION and SUDDEN DEATHS See full prescribing information for complete boxed warning. • Nilotinib prolongs the QT interval. Prior to DANZITEN administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies. ( 5.3 ) Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments. ( 5.3 , 5.4 , 5.8 , 5.12 ) • Sudden deaths have been reported in patients receiving nilotinib. ( 5.4 ) Do not administer DANZITEN to patients with hypokalemia, hypomagnesemia, or long QT syndrome. ( 4 , 5.3 ) • Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors. ( 7.1 , 7.2 )
DANZITEN Target & Pathway
ProTarget
An abnormal fusion protein created by a chromosomal translocation, found in chronic myeloid leukemia (CML). BCR-ABL has constitutive kinase activity that drives leukemic cell proliferation. Targeting BCR-ABL transformed CML from a fatal disease to a manageable condition.
DANZITEN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in DANZITEN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications DANZITEN treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to DANZITEN
3 of 9FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DANZITEN FDA Label Details
Indications & Usage
FDA Label (PDF)DANZITEN is indicated for the treatment of Chronic Myeloid Leukemia.
WARNING: QT PROLONGATION and SUDDEN DEATHS • Nilotinib prolongs the QT interval. Prior to DANZITEN administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies [ see Warnings and Precautions ( 5.3 ) ]. Obtain ECGs to monitor the QTc at baseline, seven days afte...
Pro Intelligence Preview
Deep insights for DANZITEN
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2040
- • 12 active patents
Trial Analysis
- • 93 total trials
- • Stage: Declining
Competitive Landscape
- • 9 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment