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Radotinib

Generic Name
Radotinib
Drug Type
Small Molecule
Chemical Formula
C27H21F3N8O
CAS Number
926037-48-1
Unique Ingredient Identifier
I284LJY110
Background

Radotinib is under investigation for the treatment of Leukemia, Myelogenous, Chronic, BCR-ABL Positive.

Indication

Radotinib is indicated for the treatment of different types of cancer, most notably Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) with resistance or intolerance of other Bcr-Abl tyrosine-kinase inhibitors, such as patients resistant or intolerant to imatinib.

Clinical Trials
Related News

Efficacy and Safety of Dose Redution of Radotinib as a First Line Treament in Ph+ CML

Recruiting
Conditions
Chronic Phase Ph+ Chronic Myeloid Leukemia
First Posted Date
2024-10-30
Last Posted Date
2024-10-30
Lead Sponsor
Il-Yang Pharm. Co., Ltd.
Target Recruit Count
168
Registration Number
NCT06665412
Locations
🇰🇷

Hallym University Sacred Heart Hosptial, Anyang-si, Gyeonnggi-do, Korea, Republic of

🇰🇷

Keimyung University Daegu Dongsan Hospital, Daegu, Korea, Republic of

Clinical Trial to Investigate the Effects of Food on the Pharmacokinetics and Safety of Orally Administered Radotinib

Phase 1
Completed
Conditions
Drug Kinetics
Interventions
First Posted Date
2024-06-14
Last Posted Date
2025-04-30
Lead Sponsor
Il-Yang Pharm. Co., Ltd.
Target Recruit Count
24
Registration Number
NCT06461078
Locations
🇰🇷

Severance Hospital, Seoul, Korea, Republic of

Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease

Phase 2
Recruiting
Conditions
Parkinson Disease
Interventions
Drug: Placebo
First Posted Date
2020-12-31
Last Posted Date
2024-07-16
Lead Sponsor
Il-Yang Pharm. Co., Ltd.
Target Recruit Count
40
Registration Number
NCT04691661
Locations
🇫🇷

Hôpital Nantes-Hotel Dieu, Nantes, France

🇫🇷

CHU de Lyon HCL, Lyon, France

🇫🇷

CHU Limoges, Limoges, France

and more 4 locations

Randomized Evaluation of Radotinib Versus Imatinib in Phase III Study for Efficacy With Chinese Patients (RERISE China)

Phase 3
Active, not recruiting
Conditions
Chronic Myeloid Leukemia, Chronic Phase
Interventions
First Posted Date
2018-10-29
Last Posted Date
2024-10-28
Lead Sponsor
Il-Yang Pharm. Co., Ltd.
Target Recruit Count
238
Registration Number
NCT03722420
Locations
🇨🇳

Peking University People's Hospital(北京大学人民医院), Beijing, China

A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs

Phase 3
Recruiting
Conditions
Chronic Myeloid Leukemia, Chronic Phase
CML, Refractory
CML - Philadelphia Chromosome
CML, Chronic Phase
Interventions
First Posted Date
2018-03-09
Last Posted Date
2024-10-28
Lead Sponsor
Il-Yang Pharm. Co., Ltd.
Target Recruit Count
173
Registration Number
NCT03459534
Locations
🇺🇦

CTPI Chernihiv Regional Oncological Dispensary, Chernihiv, Ukraine

🇺🇦

SI Institute of Blood Pathology and Transfusion Medicine of AMSU, Lviv, Ukraine

🇺🇦

CI Cherkasy Regional Oncological Dispensary of CRC, Cherkassy, Ukraine

and more 13 locations

Radotinib as 3rd or Later Line Therapy in CP-CML

Phase 2
Conditions
Chronic Myeloid Leukemia
Interventions
First Posted Date
2015-04-21
Last Posted Date
2016-05-11
Lead Sponsor
Ulsan University Hospital
Target Recruit Count
73
Registration Number
NCT02422719
Locations
🇰🇷

Ulsan University Hospital, Ulsan, Korea, Republic of

Philadelphia Chromosome Positive CML Patients Without Optimal Response or Tolerance to Bcr-Abl TKI

Phase 1
Completed
Conditions
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Hematologic Diseases
Interventions
First Posted Date
2012-05-21
Last Posted Date
2018-08-29
Lead Sponsor
Il-Yang Pharm. Co., Ltd.
Target Recruit Count
85
Registration Number
NCT01602952
Locations
🇰🇷

Seoul St. Mary's hospital, Seoul, Seocho-gu, Korea, Republic of

🇹🇭

Local institution, Bangkok, Phyathai, Thailand

Radotinib Versus Imatinib in Newly Diagnosed Philadelphia Chromosome and Chronic Myeloid Leukemia Chronic Phase Patients

Phase 3
Completed
Conditions
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Bone Marrow Diseases
Hematologic Diseases
Interventions
First Posted Date
2012-01-18
Last Posted Date
2016-02-24
Lead Sponsor
Il-Yang Pharm. Co., Ltd.
Target Recruit Count
242
Registration Number
NCT01511289
Locations
🇹🇭

Local Institution, Bangkok, Thailand

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