Clinical Trials

Numerous clinical trials evaluate the prophylactic and therapeutic potential of taurolidine, primarily focusing on catheter lock solutions to prevent central line-associated bloodstream infections, catheter-related infections, and late-onset neonatal sepsis. Additionally, early-phase through Phase 4 studies and non-interventional protocols explore its role in treating solid malignancies, including brain, ovarian, fallopian tube, and primary peritoneal cancers. Sponsored by academic institutions and medical centers such as Memorial Sloan Kettering Cancer Center and Centre Hospitalier Regional Metz-Thionville, these trials demonstrate recruitment statuses ranging from completed and actively recruiting to not yet recruiting and terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07585188 NOT_YET_RECRUITING
CLABSI - Central Line Associated Bloodstream Infection; CRBSI - Catheter Related Bloodstream Infection; Neonatal Sepsis, Late-Onset
University of Turin, Italy
 2026-10
NCT05781295 RECRUITING
Children; Medical Device; Primary Prevention; Oncology
Institut Curie
 2024-01-19
NCT06714864 RECRUITING
Catheter-Related Infections
CorMedix Therapeutics
 2025-07-08 PHASE4
NCT06822426 RECRUITING
Central Line Associated Blood Stream Infections (CLABSI)
CorMedix Therapeutics
 2025-05-14 PHASE3
NCT07366372 COMPLETED
Taurolidine; Lock Solution; Prevention; Central Venous Catheter Infection; Intensive Care Unit
Tanta University
 2023-05-01
NCT07074821 COMPLETED
Catheter Related Blood Stream Infection; Hemodialysis; Vascular Access
Oman Ministry of Health
 2023-03-01 PHASE2
NCT05740150 UNKNOWN
Central Line-associated Bloodstream Infection (CLABSI)
Princess Maxima Center for Pediatric Oncology
 2020-10-27
NCT03539718 UNKNOWN
Hemodialysis Catheter Infection; Thrombosis; Dialysis Catheter
Ain Shams University
 2018-05-15 PHASE4
NCT02036255 COMPLETED
Patency; Infection
Universitair Ziekenhuis Brussel
 2015-05 PHASE3
NCT01826526 COMPLETED
Catheter Related Blood Stream Infections
Geert Wanten
 2013-06
NCT01948245 UNKNOWN
Catheter-related Bloodstream Infection (CRBSI) Nos
Palle Bekker Jeppesen
 2013-10 PHASE4
NCT02279121 COMPLETED
Catheter-Related Infections
Centre Hospitalier Régional Metz-Thionville
 2014-11
NCT02515201 UNKNOWN
Catheter-Related Infections
Hospital de Clinicas de Porto Alegre
 2014-09 PHASE4
NCT02279121 Completed
Catheter-Related Infections
Centre Hospitalier Régional Metz-Thionville|centre régional de pharmacovigilance de Nancy|Theradial
 2014-11 Not Applicable
NCT02009189 COMPLETED
Home Parenteral Nutrition; Central Venous Catheter
Stanley Dudrick's Memorial Hospital
 2012-11 PHASE4
NCT01243710 COMPLETED
Renal Dialysis; Catheter-Related Infections
Imperial College Healthcare NHS Trust
 2010-08 PHASE4
NCT00545831 TERMINATED
Sepsis
University Hospital, Rouen
 2007-10
NCT00749619 COMPLETED
End Stage Renal Disease; Hemodialysis
Western Galilee Hospital-Nahariya
 2007-05 PHASE3
NCT00321165 COMPLETED
Parenteral Nutrition; Infection; Sepsis
Radboud University Medical Center
 2006-06 PHASE3
NCT00022360 COMPLETED
Brain and Central Nervous System Tumors
Memorial Sloan Kettering Cancer Center
 2001-05 PHASE1
NCT00021034 COMPLETED
Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer
Memorial Sloan Kettering Cancer Center
 2001-03 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-05-13)

Check the Taurolidine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Taurolidine breaks down to generate reactive methylol derivatives that chemically cross-link bacterial cell wall components and bacterial endotoxins, thereby blocking downstream microbial adhesion mechanisms and toxic pro-inflammatory signaling cascades. This chemical inactivation promotes bacterial cell death and mitigates localized inflammatory responses, effectively inhibiting microbial colonization to prevent central line-associated bloodstream infections and catheter-related complications in clinical settings.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.