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Nilotinib 300 mg.
Nilotinib is a tyrosine kinase inhibitor that selectively blocks BCR-ABL and other kinases to inhibit abnormal cell proliferation in chronic myeloid leukemia.
Nilotinib is a tyrosine kinase inhibitor that selectively blocks BCR-ABL and other kinases to inhibit abnormal cell proliferation in chronic myeloid leukemia. Used for Chronic myeloid leukemia in chronic phase, accelerated phase, or blast crisis (BCR-ABL positive), Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
At a glance
| Generic name | Nilotinib 300 mg. |
|---|---|
| Also known as | Tasigna 300 mg |
| Sponsor | King Abdullah International Medical Research Center |
| Drug class | BCR-ABL tyrosine kinase inhibitor |
| Target | BCR-ABL |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Mechanism of action
Nilotinib binds to the ATP-binding pocket of BCR-ABL tyrosine kinase, preventing phosphorylation and downstream signaling that drives leukemic cell growth. It is a second-generation BCR-ABL inhibitor with improved potency and selectivity compared to imatinib, and also inhibits other kinases including PDGFR and c-KIT. By blocking these oncogenic kinases, it induces apoptosis and cell cycle arrest in chronic myeloid leukemia cells.
Approved indications
- Chronic myeloid leukemia in chronic phase, accelerated phase, or blast crisis
- Philadelphia chromosome-positive acute lymphoblastic leukemia
Common side effects
- Rash
- Pruritus
- Nausea
- Headache
- Fatigue
- Diarrhea
- Vomiting
- QT prolongation
- Myelosuppression
Key clinical trials
- Rapid Analysis and Response Evaluation of Combination Anti-Neoplastic Agents in Rare Tumors (RARE CANCER) Trial: RARE 1 Nilotinib and Paclitaxel (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)
- Combination Nilotinib and Paclitaxel in Adults With Relapsed Solid Tumors (PHASE1)
- Impact of Nilotinib on Safety, Biomarkers and Clinical Outcomes in Mild to Moderate Alzheimer's Disease (PHASE2)
- A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP) (PHASE3)
- A Study of Full Treatment-free Remission in Patients With Chronic Myeloid Leukemia (PHASE2)
- Molecular Profiling of Advanced Soft-tissue Sarcomas (PHASE3)
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 300 mg. CI brief — competitive landscape report
- Nilotinib 300 mg. updates RSS · CI watch RSS
- King Abdullah International Medical Research Center portfolio CI