TIOPRONIN · Teva
Tiopronin helps patients with severe homozygous cystinuria by preventing the formation of cystine stones. It is used for adults and children 9 years of age and older who have not responded sufficiently to high fluid intake, alkali, and diet modifications alone. This medication works as a reducing and complexing thiol to supplement these other preventative strategies.
How TIOPRONIN Works
This drug works by lowering the concentration of cystine in the urine until it is below its solubility limit. It acts as a reducing agent that undergoes a chemical exchange with cystine to form a water-soluble disulfide, which reduces the amount of insoluble cystine available to form stones.
Details
- Status
- Prescription
- First Approved
- 1988-08-11
- Routes
- ORAL
- Dosage Forms
- TABLET, DELAYED RELEASE, TABLET
TIOPRONIN Approval History
What TIOPRONIN Treats
2 indicationsTIOPRONIN is approved for 2 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cystine Stone Formation
- Cystinuria
TIOPRONIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Teva's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01095731 results posted | AAAA8597 1R01FD003728-01 | Ph 2 | completed | The Effects of Tiopronin on 3-Aminopropanal Level & Neurologic Outcome After Aneurysmal Subarachnoid Hemorrhage |
| NCT03663855 results posted | 18-00642 | Ph 2 | completed | Effect of Increasing Doses of Tiopronin on Cystine Capacity in Patients With Cystinuria |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
TIOPRONIN FDA Label Details
Indications & Usage
Tiopronin delayed-release tablets are indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 9 years of age and older with severe homozygous cystinuria, who are not responsive to these measures alone. Additional pediatric use information is approved for Mission Pharmacal Company’s Thiola EC (tiopronin) delayed release tablets. However, due to Mission Pharmacal Company’s marketing exclusivity rights, this drug product is not labeled with that information. Tiopronin delayed-release tablets ar...
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TIOCYSTIN
Full clinical data, patents, trials, and competitive landscape for tiopronin.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.