THIOLA EC (tiopronin)
Thiola EC helps patients with severe homozygous cystinuria prevent the formation of cystine stones. It is used for adults and children weighing at least 20 kg when lifestyle changes like diet, high fluid intake, and alkali therapy are not sufficient on their own. This medication provides an additional layer of protection for those at risk of developing these specific types of kidney stones.
How THIOLA EC Works
This drug works by lowering the concentration of cystine in the urine so it stays below the level where it would normally crystallize. As a reducing agent, tiopronin interacts with cystine to create a new, water-soluble substance called a tiopronin-cysteine disulfide. By converting the hard-to-dissolve cystine into this soluble form, the medication prevents stones from forming.
Details
- Status
- Prescription
- First Approved
- 2019-06-28
- Patent Cliff
- 2038
- Routes
- ORAL
- Dosage Forms
- TABLET, DELAYED RELEASE
THIOLA EC Approval History
What THIOLA EC Treats
1 indicationsTHIOLA EC is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cystinuria
THIOLA EC Competitive Set
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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.
Drugs Similar to THIOLA EC
3 of 6FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
THIOLA EC FDA Label Details
Indications & Usage
FDA Label (PDF)THIOLA EC is indicated for the treatment of Cystinuria.
THIOLA EC Patents & Exclusivity
Patents (1 active)
Exclusivity
Pro Intelligence Preview
Deep insights for THIOLA EC
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 4 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 6 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.