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Drugs and Medicinal Substances

Radotinib

Antineoplastic and Immunomodulating Agents

Radotinib, sold under the brand name Supect, is an oral medication used to treat a specific type of leukemia. It is a Bcr-Abl tyrosine kinase inhibitor that selectively inhibits the Bcr-Abl tyrosine kinase, the abnormal fusion protein expressed in Philadelphia chromosome-positive chronic myeloid leukemia, and it also inhibits the platelet-derived growth factor receptor, suppressing the proliferation of leukemic cells. It is indicated for adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase who are resistant or intolerant to first-generation tyrosine kinase inhibitors such as imatinib. It received regulatory approval in South Korea in 2012 and, as of the source's most recent update, remains unapproved by the United States FDA or the European Medicines Agency, with its use limited to South Korea.

Facts
Classification
Approval Status
Investigational / Clinical Trial 1
ATC ClassSourced to the subject's own account
L: Antineoplastic and Immunomodulating Agents 2
Route of Administration
Oral 3
First Approved / Isolated Year
2012 4
Sources
1. Radotinib (Wikipedia)
Lead section, approval-status statement
Quote, Lead section, approval-status statement
Radotinib (INN; trade name Supect), also known by its investigational code IY5511, is an oral Bcr-Abl tyrosine-kinase inhibitor used in the treatment of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML).
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2. Anatomical Therapeutic Chemical Classification System (Wikipedia)
WikipediaFirst-level anatomical group codes, Code L
Quote, First-level anatomical group codes, Code L
Antineoplastic and immunomodulating agents
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3. Radotinib (Wikipedia)
WikipediaInfobox drug, routes_of_administration
Quote, Infobox drug, routes_of_administration
Oral (by mouth)
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4. New Drug Approvals: Radotinib (Supect), Korea 2012
Approval history
Quote, Approval history
Radotinib (Supect) was approved for the treatment of CML on January 5, 2012 in Korea by the KFDA
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