Drugs / taurolidine
taurolidine
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | DEFENCATH | — | 2023-11-15 | fda.gov ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT00022360 | May → Oct 2001 | central nervous system neoplasm | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00021034 | Mar → Aug 2001 | fallopian tube cancer, ovarian cancer, primary peritoneal carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07074821 | Mar 2023 → Feb 2024 | — | Oman Ministry of Health | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT06822426 | May 2025 → Jan 2028 expected | — | CorMedix Therapeutics | Recruiting | No outcome recorded |
| Phase 3 | NCT00321165 | Jun 2006 → Mar 2008 | infectious disease with sepsis | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT06714864 | Jul 2025 → Jul 2028 expected | prosthesis-related infectious disease | CorMedix Therapeutics | Recruiting | No outcome recorded |
| Phase 4 | NCT03539718 | May → Nov 2018 | thrombotic disease | Ain Shams University | Unknown | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07366372 | May 2023 → Nov 2024 | — | Tanta University | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT06707480 | — | — | CorMedix | No longer available | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 3 | NCT02036255 Background | May 2015 → Jul 2017 | infectious disease | University Hospital Brussels | Completed | Met primary |
| Phase 4 | NCT02515201 Comparator | Sep 2014 → Mar 2015 | prosthesis-related infectious disease | Hospital de Clinicas de Porto Alegre | Unknown | No outcome recorded |
| Phase 4 | NCT02868697 Comparator | Nov 2013 → Aug 2015 | — | Hamad Medical Corporation | Completed | No outcome recorded |
| Phase 4 | NCT02009189 Comparator | Nov 2012 → Nov 2013 | — | Stanley Dudrick's Memorial Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2024-06-06 | CorMedix | Regulatory CORMEDIX INC. ANNOUNCES CMS GRANTS PASS-THROUGH STATUS TO DEFENCATH cormedix.com ↗
today announced that the Center for Medicare & Medicaid Services (CMS) has determined that DefenCath® qualifies for pass-through status under the hospital Out-Patient Prospective Payment System (OPPS). |
| 2024-04-19 | CorMedix | Regulatory CORMEDIX INC. ANNOUNCES CMS GRANTS TDAPA TO DEFENCATHDefenCath® (taurolidine and heparin)IMPORTANT SAFETY INFORMATION cormedix.com ↗
CMS determination of TDAPA eligibility for DefenCath is a critical step toward ensuring this innovative preventative drug product is available for patients in the outpatient dialysis setting. |
| 2024-04-11 | CorMedix | Results CORMEDIX INC. ANNOUNCES ABSTRACTS AT UPCOMING SOCIETY FOR HEALTHCARE EPIDEMIOLOGY OF AMERICA CONFERENCE cormedix.com ↗
Based on these data, taurolidine demonstrated broad antimicrobial activity against all gram-positive bacteria, including non-tuberculosis Mycobacteria (NTM), gram-negative bacteria, and fungal isolates tested. |
| 2023-11-15 | CorMedix | Regulatory CORMEDIX INC. ANNOUNCES FDA APPROVAL OF DEFENCATH® TO REDUCE THE INCIDENCE OF CATHETER-RELATED BLOODSTREAM INFECTIONS IN ADULT HEMODIALYSIS PATIENTS cormedix.com ↗
DefenCath is the first and only FDA-approved antimicrobial CLS in the U.S. and was shown to reduce the risk of CRBSIs by up to 71% in a Phase 3 clinical study. |
| 2023-05-16 | CorMedix | Regulatory CORMEDIX INC. ANNOUNCES RESUBMISSION OF NEW DRUG APPLICATION FOR DEFENCATH cormedix.com ↗
today announced that the New Drug Application for DefenCath was resubmitted to the U.S. Food and Drug Administration, and the submission has been acknowledged as received for processing. |
| 2022-02-28 | CorMedix | Regulatory CORMEDIX INC. ANNOUNCES RESUBMISSION of NEW DRUG APPLICATION FOR DEFENCATH cormedix.com ↗
The FDA has 30 days to review the submission for completeness to accept for filing and provide guidance on the review timeline. |
| 2021-03-01 | CorMedix | Regulatory CORMEDIX RECEIVES COMPLETE RESPONSE LETTER FROM FDA FOR DEFENCATH™ CATHETER LOCK SOLUTION cormedix.com ↗
CorMedix Inc. (NASDAQ: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, announced today that the US Food and Drug Administration (FDA) cannot approve the New Drug Application (NDA) for DefenCath™ (taurolidine/heparin catheter lock solution) in its present form. |
All press releases naming this drug 8 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Taurolidine | “1.35% taurolidine citrate (2H-1,2,4-thiadiazine-4,4'-methylenebis\[tetrahydro-1,1,1',1'-tetraoxide\], 4% citrate and 500 IU/ml heparin (TauroLock Hep500) (TauroPharmGmbH” NCT02868697 ↗ |
| Known as | (cyclo)-taurolidine | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105420 ↗ |
| Known as | Taurolidina | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105420 ↗ |
| Known as | Taurolidine Citrate | “Taurolidine Citrate and Unfractionated Heparin Combination Versus Unfractionated Heparin Alone in Prevention of Inflammation in Hemodialysis Catheters.” NCT03539718 ↗ |
| Known as | Taurolidine component of defencath | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105420 ↗ |
| Known as | Taurolidine component of taurolock | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105420 ↗ |
| Known as | W-3100M | ChEMBL registry synonym — accepted as the source's own label CHEMBL2105420 ↗ |
| Modality | Small molecule | — CHEMBL2105420 ↗ |
| Route | Intravenous | “Patients receive taurolidine IV over 1-4 hours” NCT00022360 ↗ |