Milciclib Clinical Trials

Size	Price	Qty
5mg	USD 270
1g	USD 3,990

Clinical Trials

Sponsored by Tiziana Life Sciences LTD, milciclib has been evaluated in several Phase II clinical trials for oncological indications, including malignant thymoma, thymic carcinoma, advanced non-small cell lung cancer, and hepatocellular carcinoma. Among these, a clinical trial examining oral milciclib maleate in unresectable or metastatic hepatocellular carcinoma reached completed status, whereas studies in malignant thymoma and thymic carcinoma were terminated. Additionally, a clinical trial combining milciclib with gemcitabine for advanced non-small cell lung cancer carries an unknown recruitment status, highlighting the agent's overall development across refractory solid tumors.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05651269	UNKNOWN	NSCLC	Tiziana Life Sciences LTD	2023-03-15	PHASE2
NCT03109886	COMPLETED	Hepatocellular Carcinoma	Tiziana Life Sciences LTD	2017-07-12	PHASE2
NCT01301391	TERMINATED	Malignant Thymoma	Tiziana Life Sciences LTD	2011-02-02	PHASE2
NCT01011439	TERMINATED	Thymic Carcinoma	Tiziana Life Sciences LTD	2010-02-22	PHASE2

(data from https://clinicaltrials.gov, updated on 2022-12-15)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Milciclib functions as an ATP-competitive inhibitor primarily targeting cyclin-dependent kinase 2 (CDK2) and tropomyosin receptor kinase A (TRKA), thereby blocking retinoblastoma protein phosphorylation and downstream cell cycle signaling cascades. This molecular inhibition induces G1 phase cell cycle arrest, promotes autophagy, and suppresses tumor cell proliferation, providing a mechanistically grounded rationale for its clinical evaluation in advanced solid malignancies such as hepatocellular carcinoma and non-small cell lung cancer.

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>).