Clinical Trials

Sponsored by Sun Pharma Advanced Research Company Limited, several clinical trials are evaluating the novel small molecule vodobatinib (K0706) for neurodegenerative conditions and hematologic malignancies. Specifically, a randomized Phase 2 trial is investigating the drug in subjects diagnosed with early Parkinson's disease, while a multi-part Phase 1/2 study evaluates its safety, pharmacokinetics, and preliminary therapeutic activity in healthy volunteers and patients with chronic myeloid leukemia. These clinical evaluations are currently designated with an active, not recruiting status.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03655236 Active not recruiting
Early Parkinson Disease
Sun Pharma Advanced Research Company Limited
 2019-02-18 Phase 2
NCT02629692 Active not recruiting
Healthy (For Part A)|Chronic Myeloid Leukemia (for Part B and C)
Sun Pharma Advanced Research Company Limited
 2017-04-25 Phase 1|Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Vodobatinib (K0706) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vodobatinib selectively binds to the ATP-binding site of BCR-ABL1 tyrosine kinase, inhibiting autophosphorylation and downstream kinase signaling pathways critical for cell proliferation and survival. By suppressing aberrant tyrosine kinase activity, vodobatinib mitigates leukemic cell progression in chronic myeloid leukemia and targets neuroprotective signal transduction mechanisms implicated in early Parkinson's disease.

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.