Clinical Trials

Multiple clinical trials evaluate radotinib across Phase 1 through Phase 3 for oncological and neurodegenerative indications, primarily targeting Philadelphia chromosome-positive chronic myeloid leukemia and Parkinson's disease, as well as oral drug kinetics. These studies—including Phase 3 trials comparing radotinib against imatinib and Phase 2 evaluations in Parkinson's disease—are sponsored by commercial entities like Il-Yang Pharm. Co., Ltd. and medical centers such as Ulsan University Hospital and Asan Medical Center. Across this portfolio, recruitment statuses range from active and recruiting to completed and withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03459534 RECRUITING
Chronic Myeloid Leukemia, Chronic Phase; CML, Chronic Phase; CML, Refractory; CML - Philadelphia Chromosome
Il-Yang Pharm. Co., Ltd.
 2018-06-25 PHASE3
NCT04691661 ACTIVE_NOT_RECRUITING
Parkinson Disease
Il-Yang Pharm. Co., Ltd.
 2021-09-09 PHASE2
NCT06461078 COMPLETED
Drug Kinetics
Il-Yang Pharm. Co., Ltd.
 2024-07-22 PHASE1
NCT03722420 ACTIVE_NOT_RECRUITING
Chronic Myeloid Leukemia, Chronic Phase
Il-Yang Pharm. Co., Ltd.
 2018-12-28 PHASE3
NCT04691661 Recruiting
Parkinson Disease
Il-Yang Pharm. Co. Ltd.
 2021-09-09 Phase 2
NCT02422719 UNKNOWN
Chronic Myeloid Leukemia
Ulsan University Hospital
 2015-04 PHASE2
NCT01511289 COMPLETED
Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Philadelphia Chromosome; Bone Marrow Diseases; Hematologic Diseases
Il-Yang Pharm. Co., Ltd.
 2011-08 PHASE3
NCT01602952 COMPLETED
Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Philadelphia Chromosome; Hematologic Diseases
Il-Yang Pharm. Co., Ltd.
 2008-07 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-09-03)

Check the Radotinib product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Radotinib functions as a selective tyrosine kinase inhibitor that binds to the ATP-binding site of BCR-ABL1 with an IC50 of 34 nM, blocking downstream autophosphorylation and oncogenic kinase signaling cascades. This molecular inhibition arrests leukemic cell cycle progression and triggers programmed cell death, underpinning its therapeutic efficacy in chronic myeloid leukemia and related clinical conditions studied in trials.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.