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news.The US Food and Drug Administration (FDA) has given its approval to CorMedix to start a pivotal clinical trial of its investigational new drug, Neutrolin, in the US.
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The IND was based on a pivotal Phase III protocol for Neutrolin in hemodialysis patients with a central venous catheter.
The multi-center, randomized, controlled Phase III clinical trial will be conducted in the US and Europe, and will be led by Dr Michael Allon, Professor, Department of Medicine, Division of Nephrology, University of Alabama, Birmingham.
CorMedix chief scientific officer Dr Antony Pfaffle said: "The approval to initiate our pivotal clinical trial is an exciting development that we hope 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."
Currently, the company is developing an additional Phase III protocol to support the use of Neutrolin to prevent catheter related infections for oncology patients receiving total parenteral nutrition.
The company is focused on developing and commercializing therapeutic products for the prevention and treatment of cardiac, renal and infectious diseases.