Mizoribine Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 297

Clinical Trials

Multiple mid- to late-phase clinical trials evaluate the efficacy and safety of mizoribine across renal, autoimmune, and transplant-related indications, including lupus nephritis, rheumatoid arthritis, nephrotic syndrome, kidney transplant immunosuppression, and BK virus complications. Sponsored by pharmaceutical companies such as Asahi Kasei Therapeutics Corporation, Sanofi, Lee's Pharmaceutical Limited, and Chong Kun Dang Pharmaceutical, these studies include both completed trials and those that are active or of unknown recruitment status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06114953	UNKNOWN	Kidney Transplant Immunosuppression	Lee's Pharmaceutical Limited	2023-01-01	PHASE4
NCT05293704	UNKNOWN	Kidney Transplant Recipients; BK Virus	Lee's Pharmaceutical Limited	2022-05-01	PHASE4
NCT02256150	COMPLETED	Lupus Nephritis	Asahi Kasei Therapeutics Corporation	2014-11	PHASE3
NCT02257697	COMPLETED	Nephrotic Syndrome	Asahi Kasei Therapeutics Corporation	2014-11	PHASE3
NCT02373202	COMPLETED	Rheumatoid Arthritis	Sanofi	2015-02	PHASE3
NCT02005757	UNKNOWN	Rheumatoid Arthritis	Chong Kun Dang Pharmaceutical	2013-11	PHASE2

(data from https://clinicaltrials.gov, updated on 2023-11-02)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Mizoribine selectively binds to and inhibits inosine-5'-monophosphate dehydrogenase and guanosine monophosphate synthetase, thereby blocking the de novo pathway of purine nucleotide synthesis required for nucleic acid production. This metabolic inhibition halts lymphocytic DNA synthesis during the S phase of the cell cycle to suppress immune cell proliferation, providing therapeutic efficacy in managing autoimmune conditions like lupus nephritis and preventing graft rejection in kidney transplant recipients.

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>).