Drug Profile

Nilotinib - Novartis Pharmaceuticals Corporation

Alternative Names: AMN-107; Nilotinib-nanoparticle-formulation-Xspray-Pharma; RightSize-nilotinib; Tasigna

Latest Information Update: 28 Mar 2025

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At a glance

Originator Novartis Pharmaceuticals Corporation
Developer Centre Hospitalier Univeristaire De Lille; Dana-Farber Cancer Institute; Hospital for Special Surgery; Novartis Pharmaceuticals Corporation; Seoul St. Mary's Hospital; University Health Network of Toronto; University of California, San Diego
Class Anilides; Aniline compounds; Antineoplastics; Benzamides; Fluorinated hydrocarbons; Imidazoles; Ketones; Pyridines; Pyrimidines; Small molecules; Toluenes
Mechanism of Action Bcr-Abl tyrosine kinase inhibitors; Platelet-derived growth factor alpha receptor antagonists; Platelet-derived growth factor beta receptor antagonists; Proto-oncogene protein c-kit inhibitors

Orphan Drug Status

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

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

Marketed Chronic myeloid leukaemia
Phase II Acral lentiginous melanoma; Gastrointestinal stromal tumours; Glioblastoma; Graft-versus-host disease; Malignant melanoma; Precursor cell lymphoblastic leukaemia-lymphoma
Phase I/II Acute myeloid leukaemia
No development reported Colorectal cancer; Head and neck cancer; Hypereosinophilic syndrome; Systemic scleroderma
Discontinued Eosinophilia

23 Jan 2025 Novartis completes the phase II ENESTFreedom trial in Chronic myeloid leukaemia (first-line therapy) in USA, Argentina, Austria, Belgium, Bulgaria, Colombia, Denmark, France, Germany, Greece, Hungary, Italy, Ireland, Japan, Netherlands, Poland, Spain, Sweden, and the UK (PO, Capsule) (NCT01784068)
09 Dec 2023 Efficacy and adverse event data from a phase II DANTE trial in Chronic myeloid leukaemia presented at the 65th American Society of Hematology Annual Meeting and Exposition (ASH-Hem-2023)
02 Oct 2023 Novartis completes a phase II trial for Gastrointestinal stromal tumours in Japan (PO) (NCT01863745)

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