Drug Profile

Imatinib - Novartis

Alternative Names: CGP 57148; CGP 57148B; CTI 571; Gleevec; Glivec; Imatinib mesilate; Imatinib mesylate; QTI 571; Ruvise; STI 571

Latest Information Update: 27 Mar 2025

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At a glance

Originator Novartis
Developer Dana-Farber Cancer Institute; Novartis; University of Texas M. D. Anderson Cancer Center
Class Amines; Anti-inflammatories; Antineoplastics; Antivirals; Benzamides; Eye disorder therapies; Piperazines; Pyridines; Pyrimidines; Small molecules
Mechanism of Action Angiogenesis inhibitors; Bcr-Abl tyrosine kinase inhibitors; Platelet-derived growth factor receptor antagonists; Proto-oncogene protein c-kit inhibitors; Signal transduction pathway inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Gastrointestinal stromal tumours; Chronic myeloid leukaemia; Precursor cell lymphoblastic leukaemia-lymphoma; Dermatofibrosarcoma
New Molecular Entity Yes

Marketed Chronic myeloid leukaemia; Dermatofibrosarcoma; Gastrointestinal stromal tumours; Hypereosinophilic syndrome; Myelodysplastic syndromes; Precursor cell lymphoblastic leukaemia-lymphoma; Systemic mastocytosis
Phase II Acral lentiginous melanoma; Acute myeloid leukaemia; Fibroma; Malignant melanoma; Non-Hodgkin's lymphoma; Prostate cancer
No development reported Mesothelioma
Discontinued Diffuse scleroderma; Glioblastoma; Non-small cell lung cancer; Polycythaemia vera; Pulmonary arterial hypertension; Sarcoma; Small cell lung cancer; Systemic scleroderma

26 Feb 2025 Novartis completes the phase II ASC4MORE trial in Chronic myeloid leukaemia (Combination therapy, Second-line therapy or greater) in USA, Czech Republic, Austria, Portugal, the UK, Germany, Poland, Portugal, Denmark, Italy, Canada, France, South Korea, Russia, Spain, Taiwan (NCT03578367)
10 Dec 2022 Efficacy and adverse events data from a phase II ASC4MORE trial in Chronic myeloid leukaemia presented at 64th American Society of Hematology Annual Meeting and Exposition 2022 (ASH-Hem-2022)
11 Nov 2021 Novartis in collaboration with Asan Medical Center completes a phase Ib/II clinical trial in Gastrointestinal stromal tumours (Second-line therapy or greater, Metastatic disease, Combination therapy, Inoperable/Unresectable) in South Korea (IV) (NCT03609424)

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