Overview
Taurolidine has been investigated for the prevention of Central Venous Catheter, Home Parenteral Nutrition, and Catheter-Related Infections.
Indication
Not Available
Associated Conditions
- Infection
- Soft Tissues Infections
- Tissue Adhesions
- Perioperative infection
Research Report
Taurolidine: A Comprehensive Monograph on its Pharmacology, Clinical Efficacy, and Therapeutic Applications
Section 1: Introduction and Chemical Profile
1.1. Overview and Historical Context
Taurolidine is a synthetic small molecule antimicrobial agent derived from the naturally occurring amino acid, taurine.[1] First synthesized in the 1970s, its development marked the introduction of a novel therapeutic agent with a unique mechanism of action distinct from conventional antibiotics.[1] The initial clinical application of taurolidine was as a prophylactic agent for the prevention and treatment of intraperitoneal bacterial infections, particularly in patients with peritonitis, where it was often used as a surgical lavage solution.[1] This early use established its reputation as a potent, broad-spectrum antimicrobial with a favorable safety profile in local applications.
Over the subsequent decades, the clinical utility of taurolidine has evolved significantly. Recognizing its ability to prevent the formation of microbial biofilms and its low propensity for inducing bacterial resistance, its application shifted towards the prevention of catheter-related infections, a major source of morbidity and mortality in patients requiring long-term vascular access.[7] This has become its primary and most well-established therapeutic role, culminating in its approval in various formulations worldwide for use as a catheter lock solution.[1] Concurrently, research beginning in the late 1990s uncovered potent antineoplastic properties, sparking a parallel line of investigation into its potential as a cancer therapeutic.[2] This dual identity—as both an established anti-infective and an investigational anti-cancer agent—makes taurolidine a subject of considerable scientific and clinical interest.
1.2. Nomenclature, Identification, and Structural Classification
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/11/27 | N/A | AVAILABLE | |||
2022/10/12 | N/A | Completed | Prof. Dr. Hendrik Bonnemeier | ||
2018/05/29 | Phase 4 | UNKNOWN | |||
2015/08/04 | Phase 4 | UNKNOWN | |||
2014/01/14 | Phase 3 | Completed | |||
2013/12/11 | Phase 4 | Completed | Stanley Dudrick's Memorial Hospital | ||
2006/05/03 | Phase 3 | Completed | |||
2004/03/19 | Phase 1 | Completed | |||
2004/02/16 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| CorMedix Inc. | 72990-103 | INTRALUMINAL | 40.5 mg in 3 mL | 12/21/2023 | |
| CorMedix Inc. | 72990-105 | INTRALUMINAL | 67.5 mg in 5 mL | 12/21/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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