Clinical Trials

Several completed Phase 1 and Phase 1/2 clinical trials sponsored by Cytokinetics and GlaxoSmithKline have evaluated SB743921 across oncology indications, including solid tumors, Non-Hodgkin's lymphoma, and Hodgkin's disease. These studies assessed the safety, pharmacokinetics, and potential efficacy of intravenous dosing regimens administered either every three weeks or on days 1 and 15 of treatment cycles.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00343564 COMPLETED
Non-Hodgkin's Lymphoma; Hodgkin's Disease
Cytokinetics
2006-04 PHASE1; PHASE2
NCT00343564 Completed
Non-Hodgkin''s Lymphoma|Hodgkin''s Disease
Cytokinetics
2006-04 Phase 1|Phase 2
NCT00136513 COMPLETED
Solid Tumor Cancer
GlaxoSmithKline
2004-04 PHASE1

(data from https://clinicaltrials.gov, updated on 2020-01-13)

Check the SB743921 HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

SB743921 selectively binds to kinesin spindle protein (KSP/Eg5) with high affinity, inhibiting its ATPase activity and disrupting intracellular motor transport required for proper mitotic bipolar spindle assembly. This functional blockade prevents chromosome segregation and induces mitotic arrest at the G2/M phase, triggering cytotoxic apoptosis to suppress cell growth across clinical indications such as solid tumors, Non-Hodgkin's lymphoma, and Hodgkin'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>).

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