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Nilotinib, Imatinib
Nilotinib and Imatinib are tyrosine kinase inhibitors that block BCR-ABL and other kinase signaling pathways to suppress abnormal cell proliferation in chronic myeloid leukemia and gastrointestinal stromal tumors.
Nilotinib and Imatinib are tyrosine kinase inhibitors that block BCR-ABL and other kinase signaling pathways to suppress abnormal cell proliferation in chronic myeloid leukemia and gastrointestinal stromal tumors. Used for Chronic myeloid leukemia (CML), chronic phase, Chronic myeloid leukemia (CML), accelerated phase and blast crisis, Gastrointestinal stromal tumor (GIST), KIT-positive.
At a glance
| Generic name | Nilotinib, Imatinib |
|---|---|
| Also known as | Nilotinib (AMN107): Tasigna, Imatinib (STI571): Gleevec |
| Sponsor | Seoul St. Mary's Hospital |
| Drug class | Tyrosine kinase inhibitor (TKI) |
| Target | BCR-ABL, KIT, PDGFRA |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Both drugs inhibit the constitutively active BCR-ABL fusion protein that drives chronic myeloid leukemia (CML) by binding to the ATP-binding pocket of the kinase domain. Nilotinib is a second-generation inhibitor with improved potency and selectivity compared to imatinib, while imatinib was the first-in-class BCR-ABL inhibitor. Both also inhibit KIT and PDGFRA, making them effective in gastrointestinal stromal tumors (GISTs).
Approved indications
- Chronic myeloid leukemia (CML), chronic phase
- Chronic myeloid leukemia (CML), accelerated phase and blast crisis
- Gastrointestinal stromal tumor (GIST), KIT-positive
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Rash
- Fatigue
- Headache
- Muscle cramps
- Myelosuppression (anemia, thrombocytopenia, neutropenia)
- Elevated liver enzymes
Key clinical trials
- 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)
- A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP (PHASE3)
- Ponatinib Hydrochloride as Second Line Therapy in Treating Patients With Chronic Myeloid Leukemia in Chronic Phase Resistant or Intolerant to Imatinib Mesylate, Dasatinib, or Nilotinib (PHASE2)
- Asciminib Roll-over Study (PHASE4)
- Pembrolizumab and Dasatinib, Imatinib Mesylate, or Nilotinib in Treating Patients With Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease (PHASE2)
- Impact of Tyrosine Kinase Inhibitors on Glucose Level and Lipid Metabolism in Chronic Myeloid Leukemia Patients
- Treatment Free Remission After Combination Therapy With Ruxolitinib Plus Tyrosine Kinase Inhibitors (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Nilotinib, Imatinib CI brief — competitive landscape report
- Nilotinib, Imatinib updates RSS · CI watch RSS
- Seoul St. Mary's Hospital portfolio CI