NRx Pharmaceuticals, Inc. announced that its Investigational New Drug Application (IND) for the use of NRX-101, the company's patented combination of D-cycloserine and lurasidone, for the treatment of complicated Urinary Tract infections (cUTI), received clearance from the US FDA. The D-cycloserine (DCS) component of NRX-101 is well known as an antibiotic and is excreted unmetabolized in the urine. However, the NMDA-antagonist effects of DCS led to its use in the United States, while it has remained a widely used anti-tuberculosis agent by the World Health Organization.

NRx's patented discovery that combining DCS with small amounts of lurasidone counters the CNS side effects potentially and renders NRX-101 an important, patented antibiotic, just at a time when Americans are increasingly facing intravenous antibiotic therapy and even hospitalization and death from pathogens that were readily controlled a generation ago. As previously disclosed, the company sees the value for this program in an independent company dedicated to the development and commercialization of NRX-101 for cUTI. The company awaits the FDA's response to its request for Qualified Infectious Disease Product (QIDP) designation, expected next month.