Nilotinib is under clinical development by Novartis and currently in Phase II for Tenosynovial Giant Cell Tumor. According to GlobalData, Phase II drugs for Tenosynovial Giant Cell Tumor have a 75% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Nilotinib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Nilotinib overview

Nilotinib (Tasigna, AMN107) is a signal transduction inhibitor of the tyrosine kinase activity of Bcr-Abl, Kit and the PDGF-receptor. Nilotinib is an analog of imatinib with similar multiple kinase targets, but without inhibition of the Src gene. It is formulated as hard gelatin capsule for oral route of administration. Tasigna is indicated for the treatment of newly diagnosed philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) as well as treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) in adult patients resistant or intolerant to prior therapy that included imatinib and for the treatment of pediatric patients greater than or equal to 1 year of age with chronic phase Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) with resistance or intolerance to prior tyrosine -kinase inhibitor (TKI) therapy.

Nilotinib is under development for the treatment of Philadelphia positive acute lymphocytic leukemia, metastatic pigmented villonodular synovitis, tenosynovial giant cell tumor, diffuse type giant cell tumor, solid tumors including colorectal cancer, chronic graft versus host disease (GVHD), Alzheimer's disease and Parkinson's disease.

It was under development for the treatment of metastatic melanoma with c-KIT mutation, acute myeloid leukemia, gastrointestinal stromal tumor (first line), pulmonary arterial hypertension, recurrent glioblastoma (GBM), and vestibular Schwannomas and systemic sclerosis (scleroderma), head and neck cancer squamous cell carcinoma, anaplastic astrocytoma, anaplastic oligodendroglioma and anaplastic mixed oligoastrocytoma.      

Novartis overview

Novartis is a healthcare company that focuses on the discovery, development, manufacture and marketing of prescription and generic pharmaceutical products and eye care products. It provides drugs for the treatment of cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, hematologic diseases, solid tumors, immune disorders, and infections, among others. The company offers generic medicines and biosimilars through Sandoz. Novartis conducts research in various disease areas through The Novartis Institutes for BioMedical Research (NIBR). The company operates through a network of subsidiaries and offices across the Americas, Europe, the Middle East, Africa, and Asia-Pacific. Novartis is headquartered in Basel, Switzerland.

For a complete picture of Nilotinib’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.