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Cuprimine (PENICILLAMINE)
Cuprimine (Penicillamine) is a small molecule antirheumatic agent originally developed by Aton and currently owned by Valeant Pharmaceuticals International. It was FDA-approved in 1970 for the treatment of Cystine Renal Calculi, Cystinuria, Rheumatoid arthritis, and Wilson's disease. Cuprimine is available as a generic medication, with 11 generic manufacturers, and is off-patent. Key safety considerations include its potential to cause adverse effects such as hematologic, renal, and dermatologic reactions. As an off-patent medication, Cuprimine is widely available and accessible.
At a glance
| Generic name | PENICILLAMINE |
|---|---|
| Sponsor | Valeant Pharms Intl |
| Drug class | Antirheumatic Agent [EPC] |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 1970 |
Approved indications
- Cystine Renal Calculi
- Cystinuria
- Rheumatoid arthritis
- Wilson's disease
Boxed warnings
- Physicians planning to use penicillamine should thoroughly familiarize themselves with its toxicity, special dosage considerations, and therapeutic benefits. Penicillamine should never be used casually. Each patient should remain constantly under the close supervision of the physician. Patients should be warned to report promptly any symptoms suggesting toxicity.
Common side effects
- Gastrointestinal side effects
- Leukopenia
- Thrombocytopenia
- Proteinuria
- Urticaria
- Exfoliative dermatitis
- Anorexia
- Epigastric pain
- Nausea
- Vomiting
- Diarrhea
- Blunting of taste perception
Key clinical trials
- Trientine Tetrahydrochloride Administered Once a Day for the First Line Treatment of Wilson's Disease Patients. (PHASE3)
- Off Treatment Urinary Copper Excretion in Wilson Disease, Pilot Study
- Wilson's Disease Treated With D-Penicillamine: Characterization of Skin Damage Secondary to Treatment by Measuring Skin Elasticity (NA)
- Real World Evidence Study in Subjects With Wilson's Disease
- International Wilson's Disease Patient Registry (iWilson Registry)
- Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's Disease (PHASE3)
- Study of ALXN1840 Versus Standard of Care in Pediatric Participants With Wilson Disease (PHASE3)
- A Study to Assess Safety and Efficacy of ASP015K in Participants With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to Methotrexate (MTX) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Cuprimine CI brief — competitive landscape report
- Cuprimine updates RSS · CI watch RSS
- Valeant Pharms Intl portfolio CI