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.
Mechanism and Biochemical Profile
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.