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Data updated: Mar 10, 2026

SYPRINE

TRIENTINE HYDROCHLORIDE
Immunology Approved 1985-11-08
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
40
Years on Market

Details

Status
Prescription
First Approved
1985-11-08
Routes
ORAL
Dosage Forms
CAPSULE

Companies

BAUSCH
Active Ingredient: TRIENTINE HYDROCHLORIDE

SYPRINE Approval History

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What SYPRINE Treats

4 indications

SYPRINE is approved for 4 conditions since its original approval in 1985. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Wilson’s Disease
  • Cystinuria
  • Rheumatoid Arthritis
  • Biliary Cirrhosis
Source: FDA Label

Drugs Similar to SYPRINE

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DEPEN
PENICILLAMINE
3 shared
Viatris
Shared indications:
Wilson’s DiseaseCystinuriaRheumatoid Arthritis
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CATAFLAM
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

SYPRINE FDA Label Details

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Indications & Usage

Syprine is indicated in the treatment of patients with Wilson’s disease who are intolerant of penicillamine. Clinical experience with Syprine is limited and alternate dosing regimens have not been well-characterized; all endpoints in determining an individual patient’s dose have not been well defined. Syprine and penicillamine cannot be considered interchangeable. Syprine should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects. Unlike penicillamine, Syprine is not recommended in cystinuria or rheumatoid arthritis....

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Data Sources

FDA Approval: NDA019194 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.