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news.CorMedix has submitted an investigational new drug (IND) application for Neutrolin to the US Food and Drug Administration (FDA).
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The IND application includes a pivotal Phase III protocol for Neutrolin in hemodialysis patients with a central venous catheter.
The multi-centre, randomised, controlled trial is conducted in the US and Europe.
University of Alabama Department of Medicine, Division of Nephrology professor Dr Michael Allon will be the study chair of the Neutrolin Phase III program.
CorMedix chief scientific officer Antony Pfaffle said the filing of the company’s IND is an important incremental step that we believe will lead to the availability of Neutrolin for patients in the US with central venous catheters.
"Neutrolin is being developed to help prevent catheter-related infections and thrombosis.
"The active anti-infective ingredient in Neutrolin is taurolidine, which has efficacy against both common and resistant forms of bacteria and fungi.
"Use of taurolidine has not been associated with the development of microbial resistance in humans."
Recently, CorMedix reported the receipt of a broad label expansion in the entire EU to include not only hemodialysis catheters, but also catheters used in chemotherapy, total parenteral nutrition and critical care settings.