CYC116 Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 370

Clinical Trials

An industry-sponsored Phase 1 clinical trial conducted by Cyclacel Pharmaceuticals, Inc. evaluated the safety, tolerability, and pharmacokinetics of CYC116 in patients with advanced solid tumors. However, recruitment for the study was terminated prior to completion. Consequently, the clinical evaluation of CYC116 remains limited to early-stage investigation in solid tumor malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00560716	TERMINATED	Solid Tumors	Cyclacel Pharmaceuticals, Inc.	2007-06	PHASE1

(data from https://clinicaltrials.gov, updated on 2021-12-22)

Check the CYC116 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

CYC116 functions by selectively binding to and inhibiting Aurora A and B kinases along with VEGFR2, thereby disrupting mitotic spindle assembly, cell cycle progression, and vascular endothelial signaling. This dual inhibition of cell proliferation and angiogenesis leads to rapid cell death and tumor growth suppression, providing the biological rationale for its clinical evaluation in advanced solid tumors.

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>).