Tetrathiomolybdate (TM) Clinical Trials

Size	Price	Qty
5mg	USD 290
25mg	USD 870

Clinical Trials

Numerous clinical trials evaluate tetrathiomolybdate across Phase 1 through Phase 4 studies for indications including Wilson disease, diabetic nephropathy, and triple-negative breast, non-small cell lung, hepatocellular, and esophageal carcinomas. Encompassing recruitment statuses from not yet recruiting and active recruitment to completion, termination, or withdrawal, these trials are sponsored by academic medical centers, government research entities, and pharmaceutical companies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06134375	RECRUITING	Triple Negative Breast Cancer; Residual Disease	Dartmouth-Hitchcock Medical Center	2024-11-26	PHASE1; PHASE2
NCT06147232	Not yet recruiting	Nephropathy\|Diabetic Nephropathies\|Diabetes Mellitus Type 1\|Albuminuria\|Diabetic Complications Renal\|Diabetic Complications Cardiovascular\|Hypoxia	Steno Diabetes Center Copenhagen\|Juvenile Diabetes Research Foundation\|King''s College London\|Glostrup University Hospital Copenhagen	2024-08	Phase 4
NCT06384157	Not yet recruiting	Opioid Use Disorder	Indivior Inc.	2024-05	Phase 2
NCT00195091	TERMINATED	Breast Cancer	Memorial Sloan Kettering Cancer Center	2003-12	PHASE2
NCT04422431	COMPLETED	Wilson Disease	Alexion Pharmaceuticals, Inc.	2020-12-02	PHASE2
NCT01837329	COMPLETED	Non-Small Cell Lung Cancer	University of Rochester	2013-11	PHASE1
NCT00805805	COMPLETED	Primary Biliary Cirrhosis	George Brewer	2006-04	PHASE3
NCT00560495	WITHDRAWN	Lung Cancer	Roswell Park Cancer Institute	2007-05	PHASE1
NCT00189176	COMPLETED	Idiopathic Pulmonary Fibrosis	University of Michigan	2003-03	PHASE1; PHASE2
NCT00176800	COMPLETED	Esophageal Carcinoma	University of Michigan Rogel Cancer Center	2001-11	PHASE2
NCT00176774	COMPLETED	Colorectal Carcinoma	University of Michigan Rogel Cancer Center	2001-02	PHASE2
NCT00150995	COMPLETED	Prostate Cancer	University of Michigan Rogel Cancer Center	2001-05	PHASE2
NCT00004339	COMPLETED	Wilson Disease	National Center for Research Resources (NCRR)	1994-01	PHASE3
NCT00006332	COMPLETED	Carcinoma, Hepatocellular	National Center for Research Resources (NCRR)		PHASE2
NCT00113542	COMPLETED	Psoriasis	University of Michigan	2004-06	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-04-20)

Check the Tetrathiomolybdate (TM) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tetrathiomolybdate acts as a copper-chelating agent that induces dimerization of the metal-binding domain of the cellular copper efflux protein ATP7B through a unique sulfur-bridged Mo2S6O2 cluster. By sequestering systemic copper, it disrupts downstream copper-dependent biochemical pathways essential for cell proliferation and angiogenesis, offering therapeutic utility in Wilson disease and copper-dependent malignancies such as triple-negative breast 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>).