TheraRadar
Data updated: Jul 17, 2026

TIOCYSTIN (tiopronin) · CASPER PHARMA LLC

Approved 2026-06-02

TIOCYSTIN is FDA-approved to treat 2 conditions (same as TIOPRONIN).

Source: FDA Label
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

2 indications

TIOCYSTIN is approved for 2 conditions since its original approval in 2026. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Cystine Stone Formation
  • Cystinuria

Same approved indications as TIOPRONIN (same active ingredient).

Source: FDA Label
📋

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

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
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

Indications & Usage

FDA Label (PDF)

TIOCYSTIN is FDA-approved to treat 2 conditions — same approved indications as TIOPRONIN.

Track TIOCYSTIN with TheraRadar Pro

Watchlist alerts, full database access, CSV exports across 14,000+ drugs.

Upgrade to Pro

Data Sources

FDA Approval: NDA212927 → Trials: ClinicalTrials.gov →

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