Tetrathiomolybdate

Overview

Tetrathiomolybdate is an oral, small-molecule, anticopper agent that is highly specific for lowering the levels of free copper in serum. COPREXA has completed pivotal clinical trials for the treatment of neurologic Wilson's disease. It is also developed for fibrotic disorders based upon the rationale that the fibrotic disease process is dependent upon the availability of free copper in the body.

Background

Indication

Investigated for use/treatment in liver disease and pulmonary fibrosis.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study of Tetrathiomolybdate (TM) Plus Capecitabine	2023/11/18	NCT06134375	Phase 1	Recruiting	Dartmouth-Hitchcock Medical Center
Early Access Program for ALXN1840 in Patients With Wilson Disease	2023/01/17	NCT05686564	N/A	NO_LONGER_AVAILABLE	Alexion Pharmaceuticals, Inc.
Pharmacokinetic Study of Oral ALXN1840 in Japanese and Non-Japanese Adult Healthy Participants	2022/12/07	NCT05641311	Phase 1	Completed	Alexion Pharmaceuticals, Inc.
A Study of ALXN1840 (Non-coated) Administered With And Without Omeprazole In Healthy Adults	2022/04/08	NCT05319899	Phase 1	Completed	Alexion Pharmaceuticals, Inc.
Study of Oral ALXN1840 at 2 Dose Strengths in Healthy Adults	2022/03/31	NCT05303324	Phase 1	Completed	Alexion Pharmaceuticals, Inc.
Study of ALXN1840 Versus Standard of Care in Pediatric Participants With Wilson Disease	2021/09/17	NCT05047523	Phase 3	Terminated	Alexion Pharmaceuticals, Inc.
Bioavailability Study of 2 Oral Formulations of ALXN1840	2020/10/30	NCT04610580	Phase 1	Completed	Alexion Pharmaceuticals, Inc.
Copper Balance in Healthy Participants Administered ALXN1840	2020/10/20	NCT04594252	Phase 1	Completed	Alexion Pharmaceuticals, Inc.
Copper and Molybdenum Balance in Participants With Wilson Disease Treated With ALXN1840	2020/10/05	NCT04573309	Phase 2	Completed	Alexion Pharmaceuticals, Inc.
A Study of the Cardiac Effects of ALXN1840 in Healthy Adults	2020/09/23	NCT04560816	Phase 1	Completed	Alexion Pharmaceuticals, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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