Last reviewed 2026-04-20 · How we verify

Tasigna (NILOTINIB)

Tasigna works by blocking the abnormal Bcr/Abl protein that drives the growth of cancer cells in CML.

Tasigna (Nilotinib) is a small molecule kinase inhibitor originally developed by Novartis and currently owned by Cipla. It targets the Bcr/Abl fusion protein, a key driver of Chronic Myelocytic Leukemia (CML). Tasigna is FDA-approved for treating CML in accelerated phase, chronic phase, and Philadelphia chromosome-positive CML. Although off-patent, there are currently no generic manufacturers. As a kinase inhibitor, Tasigna works by blocking the abnormal Bcr/Abl protein, which helps to control the growth of cancer cells.

At a glance

Mechanism of action

Nilotinib is an inhibitor of the BCR-ABL kinase. Nilotinib binds to and stabilizes the inactive conformation of the kinase domain of ABL protein. In vitro, nilotinib inhibited BCR-ABL mediated proliferation of murine leukemic cell lines and human cell lines derived from patients with Ph+ CML. Under the conditions of the assays, nilotinib was able to overcome imatinib resistance resulting from BCR-ABL kinase mutations, in 32 out of 33 mutations tested. Nilotinib inhibited the autophosphorylation of the following kinases at IC50 values as indicated: BCR-ABL (20 to 60 nM), PDGFR (69 nM), c-KIT (210 nM), CSF-1R (125 to 250 nM), and DDR1 (3.7 nM).

Approved indications

• Chronic Myelocytic Leukemia Accelerated Phase
• Chronic phase chronic myeloid leukemia
• Philadelphia Chromosome Positive Chronic Myelocytic Leukemia

Boxed warnings

• WARNING: QT PROLONGATION and SUDDEN DEATHS Nilotinib prolongs the QT interval. Prior to nilotinib 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 nilotinib [ see Warnings and Precautions (5.3) ] . Do not administer nilotinib 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. Nilotinib prolongs the QT interval. Prior to nilotinib 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 nilotinib. ( 5.3 ) Do not administer nilotinib 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 )

Common side effects

• Myelosuppression
• Thrombocytopenia
• Neutropenia
• Anemia
• Rash
• Pruritus
• Headache
• Nausea
• Fatigue
• Diarrhea
• Constipation
• Cough

Drug interactions

• High Risk QT Prolonging Agents
• P-glycoprotein Substrates
• boceprevir
• carbamazepine
• cimetidine
• conivaptan
• dexamethasone
• dexlansoprazole
• esomeprazole
• famotidine
• fosphenytoin
• indinavir

Key clinical trials

• Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients. (PHASE2)
• A Pharmacokinetic (PK) Study of Nilotinib in Pediatric Patients With Philadelphia Chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL) (PHASE1)
• A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) (PHASE3)
• Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial (PHASE2)
• Testing the Use of Nilotinib and Paclitaxel as a Treatment for Patients With Prior Taxane Treatment, A ComboMATCH Treatment Trial (PHASE2)
• Rapid Analysis and Response Evaluation of Combination Anti-Neoplastic Agents in Rare Tumors (RARE CANCER) Trial: RARE 1 Nilotinib and Paclitaxel (PHASE2)
• Asciminib & Standard-of-Care Integration in Maintenance Therapy for POST Allogeneic Stem Cell Transplant (Allo-HSCT) of Patient With Ph+ B-ALL or Blastic Transformed CML (PHASE2)
• Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Tasigna CI brief — competitive landscape report
• Tasigna updates RSS · CI watch RSS
• Cipla portfolio CI