Thiola Ec

(Tiopronin)

ApprovedSmall molecule

Jazz Pharmaceuticals

Thiola Ec is one of 3 small molecule programs targeting Cystinuria. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

CystinuriaCompleted

CystinuriaApproved

Completed

Competition

Competitive Landscape

2 competitors in Cystinuria

#DrugCompanyPhaseTrials

Farxiga

Thiola Ec

2 3

Samsca

Otsuka

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Cystinuria2 trials

Effect of Increasing Doses of Cystine Binding Thiol Drugs on Cystine Capacity in Patients With Cystinuria

Completed·NNYU Langone Health·Phase 4·NCT02125721·10 enrolled

Effect of Increasing Doses of Tiopronin on Cystine Capacity in Patients With Cystinuria

Completed·NNYU Langone Health·Phase 2·NCT03663855·10 enrolled

Subarachnoid Hemorrhage1 trial

The Effects of Tiopronin on 3-Aminopropanal Level & Neurologic Outcome After Aneurysmal Subarachnoid Hemorrhage

Completed·EE. Sander Connolly·Phase 2·NCT01095731·60 enrolled

Drug-Induced Liver Injury1 trial

Efficacy and Safety Study of Magnesium Isoglycyrrhizinate Injection in Subjects With Acute Drug-induced Liver Injury

Completed· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 2·NCT02734966·174 enrolled

Regulatory

FDA Approval Timeline[4]

Aug 11, 1988

THIOLA

NDA NDA019569

Jun 28, 2019

THIOLA EC

NDA NDA211843

Jun 1, 2026

TIOCYSTIN

NDA NDA212927

Sources

References

[1]
ClinicalTrials.gov — 4 trial records for Tiopronin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Tiopronin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Tiopronin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA212927). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Thiola Ec. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Jazz Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Jazz Pharmaceuticals

Patent Landscape[5]

Patent Cliff

Nov 14, 2038

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11458104Nov 14, 2038

Thiola Ec

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Cystinuria2 trials

Subarachnoid Hemorrhage1 trial

Drug-Induced Liver Injury1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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