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Phase 2

Development Phase

0

Upcoming Catalysts

0

Historical Events

1

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Competitive Landscape

1 competitor in Philadelphia Positive

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Drug Information

Target Indication

Philadelphia Positive

Clinical Trial

NCT01641107

Last updated: 12/4/2025

Patent & Exclusivity

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

Regulatory Approvals
EMA7/1/2013

Iclusig

Iclusig is indicated as monotherapy in adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. Iclusig is indicated in combination with reduced-intensity chemotherapy in adult patients with newly diagnosed Ph+ ALL (see section 5.1). Iclusig is indicated as monotherapy in paediatric patients 6 years of age or older with chronic phase chronic myeloid leukaemia (CP-CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. See sections 4.2 for the assessment of cardiovascular status prior to start of therapy and 4.4 for situations where an alternative treatment may be considered.

Accelerated
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Drug Science
Mechanism of action & safety profile
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