VENXXIVA (tiopronin)
Venxxiva helps patients with severe homozygous cystinuria prevent the formation of cystine stones. It is used for adults and children aged 9 and older who continue to form stones despite maintaining high fluid intake, dietary changes, and alkali therapy. This medication works as an additional layer of protection when lifestyle and dietary modifications alone are not sufficient to manage the condition.
How VENXXIVA Works
This drug works by undergoing a chemical exchange with cystine to form a water-soluble substance called tiopronin-cysteine. By converting sparingly soluble cystine into this more soluble form, the medication lowers the concentration of cystine in the urine. This process helps keep cystine levels below the point where they would crystallize and form stones.
Details
- Status
- Prescription
- First Approved
- 2024-01-30
- Routes
- ORAL
- Dosage Forms
- TABLET, DELAYED RELEASE
VENXXIVA Approval History
What VENXXIVA Treats
2 indicationsVENXXIVA is approved for 2 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cystine Stone Formation
- Cystinuria
VENXXIVA 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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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.
VENXXIVA FDA Label Details
Indications & Usage
VENXXIVA is indicated for the treatment of Cystine Stone Formation; Cystinuria.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.