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Thiola Ec

(Tiopronin)

ApprovedSmall molecule

MMission Pharmacal

Thiola Ec is one of 61 small molecule programs targeting Cystinuria. It is currently in Approved.

3

Indications

4

Total Trials

0

Active Trials

60

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

1

Patents

Pipeline

Status by Indication[3][1]

Indication

CystinuriaActive, not recruiting

Drug-Induced Liver InjuryActive, not recruiting

Subarachnoid HemorrhageActive, not recruiting

CystinuriaApproved

Active, not recruiting

Drug-Induced Liver InjuryPhase 2

Active, not recruiting

Subarachnoid HemorrhagePhase 2

Active, not recruiting

Competition

Competitive Landscape

100 competitors in Subarachnoid Hemorrhage

#DrugCompanyPhaseTrials

Activase

Thiola Ec

MMission Pharmacal

Lipitor

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Avlosulfon

AAlmirall, S.A.

Decadron

AAspen Global Incorporated

Ketalar

Boehringer Ingelheim

Desferal

Alnylam Pharmaceuticals

Primacor

Diamox

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

Clinical

Trials by Indication[1]

Cystinuria2 trials

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

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

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

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

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 NDA211843). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Thiola Ec. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Mission Pharmacal company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: MMission Pharmacal

Patent Landscape[5]

Patent Cliff

Nov 14, 2038

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11458104Nov 14, 2038

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