TASIGNA (nilotinib hydrochloride) · Novartis
Tasigna (nilotinib) is a kinase inhibitor indicated for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). It is approved for use in newly diagnosed adult and pediatric patients (≥1 year of age) in the chronic phase (CP). Additionally, it is indicated for the treatment of Ph+ CML in both chronic and accelerated phases (AP) for: 1) adult patients resistant or intolerant to prior therapy that included imatinib, and 2) pediatric patients (≥1 year of age) resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy.
How TASIGNA Works
Nilotinib is an inhibitor of the BCR-ABL kinase. It exerts its effect by binding to and stabilizing the inactive conformation of the kinase domain of the ABL protein, thereby inhibiting the proliferation of Ph+ CML cells. Nilotinib demonstrates high potency against BCR-ABL and is capable of overcoming resistance in 32 of 33 imatinib-resistant BCR-ABL mutations
Development Insights
Details
- Status
- Prescription
- First Approved
- 2007-10-29
- Patent Cliff
- 2032
- Revenue
- $200M (Q4-2025)
- Routes
- ORAL
- Dosage Forms
- CAPSULE
TASIGNA Approval History
What TASIGNA Treats
1 indicationsTASIGNA is approved for 1 conditions since its original approval in 2007. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Myeloid Leukemia
TASIGNA Boxed Warning
QT PROLONGATION and SUDDEN DEATHS Tasigna prolongs the QT interval. Prior to Tasigna administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies [see Warnings and Precautions (5.2)] . Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments [see Warnings and Precautions (5.2, 5.3, 5.7, 5.12)] . Sudden deaths have been reported in patients receiving Tasigna [see Warnings and Pre...
WARNING: QT PROLONGATION and SUDDEN DEATHS Tasigna prolongs the QT interval. Prior to Tasigna administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies [see Warnings and Precautions (5.2)] . Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments [see Warnings and Precautions (5.2, 5.3, 5.7, 5.12)] . Sudden deaths have been reported in patients receiving Tasigna [see Warnings and Precautions (5.3)] . Do not administer Tasigna to patients with hypokalemia, hypomagnesemia, or long QT syndrome [see Contraindications (4), Warnings and Precautions (5.2)] . Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors [see Drug Interactions (7.1, 7.2)] . Avoid food 2 hours before and 1 hour after taking the dose [see Dosage and Administration (2.1)] . WARNING: QT PROLONGATION and SUDDEN DEATHS See full prescribing information for complete boxed warning. Tasigna prolongs the QT interval. Prior to Tasigna administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies. ( 5.2 ) Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments. ( 5.2 , 5.3 , 5.7 , 5.12) Sudden deaths have been reported in patients receiving Tasigna. ( 5.3) Do not administer Tasigna to patients with hypokalemia, hypomagnesemia, or long QT syndrome. ( 4 , 5.2) Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors. ( 7.1 , 7.2) Avoid food 2 hours before and 1 hour after taking the dose. ( 2.1 )
TASIGNA 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.
TASIGNA 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 TASIGNA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TASIGNA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TASIGNA
3 of 10FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Novartis's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01223898 | CAMN107A2128 2009-009425-28 | Ph 1 | completed | To Evaluate the Effects of Multiple Doses of Nilotinib on the Pharmacokinetics and Metabolism of Midazolam in CML Patients With Additional Extension Phase to Evaluate the Safety of Nilotinib |
| NCT02068898 | XS003_CT001 | Ph 1 | completed | Pharmacokinetic Comparison of XS003 and Tasigna |
| NCT00732888 | 08-077 CAMN107DUS10T, UPCI 08-077 | Ph 1 | completed | Effect of Calcium on Tasigna Pharmacokinetics (PK) in Healthy Volunteers |
| NCT01261429 | PVNS 2010-018869-29 | Ph 2 | completed | Study of Nilotinib Efficacy in Pigmented Villo-Nodular Synovitis/ Tenosynovial Giant Cell Tumour (PVNS/TGCT) |
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.
TASIGNA FDA Label Details
Indications & Usage
FDA Label (PDF)Tasigna is a kinase inhibitor indicated for the treatment of: Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. 1.1 Adult and Pediatric Patients With Newly Diagnosed Ph+ CML-...
WARNING: QT PROLONGATION and SUDDEN DEATHS Tasigna prolongs the QT interval. Prior to Tasigna administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies [see Warnings and Precautions (5.2)] . Obtain ECGs to monitor the QTc at baseline, seven days after initia...
TASIGNA Patents & Exclusivity
Patents (12 active)
Exclusivity
Pro Intelligence Preview
Deep insights for TASIGNA
Revenue Insights
- • Q4-2025: $200M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • 126 active patents
Trial Analysis
- • 4 total trials
- • Stage: Declining
Competitive Landscape
- • 10 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