TheraRadar
Data updated: Jun 28, 2026

TIOCYSTIN (tiopronin)

Approved 2026-06-02
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
0
Years on Market

Details

Status
Prescription
First Approved
2026-06-02
Routes
ORAL
Dosage Forms
TABLET

Companies

CASPER PHARMA LLC
Active Ingredient: TIOPRONIN

TIOCYSTIN Approval History

Original
New Indication
New Form
Label Update
2 FDA actions from 2026 to 2026
Jun 2026 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer
Label

What TIOCYSTIN Treats

1 FDA approvals

Originally approved for its first indication in 2026 .

  • Other (1)
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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
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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.

TIOCYSTIN FDA Label Details

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Data Sources

FDA Approval: NDA212927 → Trials: ClinicalTrials.gov →

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