Venus Remedies gains US FDA recognition for safer polymyxin B formulation

India’s Venus Remedies (NSE: VENUSREM) has secured Qualified Infectious Disease Product designation from the US Food and Drug Administration for its investigational antibiotic VRP-034, a next-generation formulation of polymyxin B designed to reduce kidney toxicity.

The designation, granted under the GAIN Act, positions VRP-034 for benefits including fast track eligibility, priority review and five additional years of market exclusivity if approved. The move highlights US regulators’ recognition of the need for safer treatments targeting drug-resistant infections.

Developed by the company’s research arm, Venus Medicine Research Centre, VRP-034 is a supramolecular cationic formulation of polymyxin B sulfate. It has been engineered to address the nephrotoxicity that limits current polymyxin B use. The drug was built on Venus Remedies’ proprietary Renal Guard technology, designed specifically to protect renal function.