Nilotinib (AMN107)

Phase 3

NOVARTIS AG (NVSEF)

Phase 3

Development Phase

Upcoming Catalysts

Historical Events

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Competitive Landscape

0 competitors in Gastrointestinal Stromal Tumor (GIST)

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Drug Information

Target Indication

Gastrointestinal Stromal Tumor (GIST)

Clinical Trial

NCT00785785

Last updated: 2/28/2026

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Source: FDA Orange Book

Regulatory Approvals

EMA8/22/2024

Nilotinib Accord

Nilotinib Accord is indicated for the treatment of: - adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, - adult patients with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available, - paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.

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Drug Science

Mechanism of action & safety profile

Developer

NVSEF

NOVARTIS AG

Biotechnology•North America•NASDAQ

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