Penicillamine

Overview

Penicillamine is a pharmaceutical of the chelator class. The pharmaceutical form is D-penicillamine, as L-penicillamine is toxic (it inhibits the action of pyridoxine). It is an α-amino acid metabolite of penicillin, although it has no antibiotic properties.

Indication

For treatment of Wilson's disease, cystinuria and active rheumatoid arthritis.

Associated Conditions

Cystinuria
Lead Poisoning
Wilson's Disease
Refractory Rheumatoid arthritis
Severe Rheumatoid arthritis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Safety and Superiority of Penicillamine in Radiosensitization of Recurrent Head and Neck Cancer	2023/10/27	NCT06103617	Phase 2	Recruiting	Nanfang Hospital, Southern Medical University
The Individual Therapy for Patients With Wilson's Disease	2019/05/21	NCT03957720	Early Phase 1	Recruiting	Second Affiliated Hospital, School of Medicine, Zhejiang University
Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's Disease	2018/05/30	NCT03539952	Phase 3	Completed	Orphalan
Delivery of Inhibitors of Lysyl Oxidase (LysoLox) on Serial Angioplasty and Time to Restenosis	2017/04/11	NCT03106948	Phase 2	UNKNOWN	Southeast Renal Research Institute
Post Marketing Surveillance Study of Cuprimine	2011/06/15	NCT01374282	N/A	NO_LONGER_AVAILABLE	Merck Sharp & Dohme LLC
Penicillamine, Low Copper Diet, and Radiation Therapy in Treating Patients With Glioblastoma	2004/08/18	NCT00003751	Phase 2	Completed	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Penicillamine	Navinta LLC	68475-201	ORAL	250 mg in 1 1	12/2/2022
Penicillamine	Granules Pharmaceuticals Inc.	70010-907	ORAL	250 mg in 1 1	2/16/2023
Penicillamine	Proficient Rx LP	71205-916	ORAL	250 mg in 1 1	4/1/2022
Depen	Meda Pharmaceuticals Inc.	0037-4401	ORAL	250 mg in 1 1	1/17/2019
Penicillamine	Bryant Ranch Prepack	72162-2112	ORAL	250 mg in 1 1	12/6/2022
Penicillamine	Par Pharmaceutical, Inc.	49884-146	ORAL	250 mg in 1 1	1/8/2020
Penicillamine	ANI Pharmaceuticals, Inc.	62559-970	ORAL	250 mg in 1 1	7/1/2021
penicillamine	Par Pharmaceutical, Inc.	0254-2000	ORAL	250 mg in 1 1	1/2/2020
Penicillamine	Apotex Corp.	60505-4696	ORAL	250 mg in 1 1	12/4/2023

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
CUPRIPEN 250 CAPSULE 250 mg	LABORATORIOS RUBIO SA	SIN08173P	CAPSULE	250 mg	5/17/1995

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
D-Penicillamine Tablets 250 mg Bulk	208819	Alphapharm Pty Ltd	Medicine	A	4/29/2013
D-PENAMINE penicillamine 250 mg tablet bottle	14626	Alphapharm Pty Ltd	Medicine	A	9/5/1991
D-PENAMINE penicillamine 125 mg tablet bottle	14625	Alphapharm Pty Ltd	Medicine	A	9/5/1991
D-Penicillamine Tablets 125 mg Bulk	208818	Alphapharm Pty Ltd	Medicine	A	4/29/2013

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
CUPRIMINE	bausch health, canada inc.	00016055	Capsule - Oral	250 MG	12/31/1964
CUPRIMINE	Merck Canada Inc	00497894	Capsule - Oral	125 MG	12/31/1980
DEPEN TAB 250MG	carter-horner corp.	00511641	Tablet - Oral	250 MG	12/31/1981

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
CUPRIPEN 50 mg COMPRIMIDOS	Laboratorios Rubio S.A.	54830	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized
CUPRIPEN 250 mg CAPSULAS	Laboratorios Rubio S.A.	53172	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

ALXN1840 Shows Promising Long-Term Efficacy and Safety for Wilson Disease at EASL 2025

3 months ago

• Monopar Therapeutics presented late-breaker data at EASL 2025 showing sustained clinical improvements in Wilson disease patients treated with ALXN1840 (tiomolybdate choline) over a median treatment duration of 2.63 years. • The pooled analysis from multiple clinical trials (n=255) demonstrated improvements in patient-reported symptoms, copper mobilization, and clinical assessments, with fewer than 5% of patients experiencing drug-related serious adverse events. • Patients reported higher convenience and effectiveness with ALXN1840 compared to standard of care, suggesting the drug candidate could provide meaningful benefits for the management of this rare genetic condition.

Orphalan Makes History as First European Company to Enter China's Wilson Disease Market with "Ke Pei Ou"

5 months ago

• Orphalan has launched trientine tetrahydrochloride ("Ke Pei Ou") in China through a strategic partnership with SPH Kyuan Trade, becoming the first European company to introduce an orphan drug for Wilson disease in this market. • The treatment addresses a critical unmet need for Chinese Wilson disease patients who cannot tolerate penicillamine, the previous standard therapy, offering an alternative that is already available in over 20 countries globally. • Orphalan has established a local entity in Shanghai led by Grace Li as General Manager, demonstrating its commitment to ensuring Chinese patients and healthcare providers have access to advanced Wilson disease treatment options.

Help Us Improve

Your feedback helps us provide better drug information and insights.

AI-Powered Research

Premium Access