The QIDP designation provides VRP-034 with significant regulatory benefits, including priority review, eligibility for fast-track designation

Venus Remedies announced that its investigational product VRP-034 has been granted Qualified Infectious Disease Product (QIDP) designation by the United States Food and Drug Administration (US FDA) for the treatment of bloodstream infections caused by polymyxin B (PMB)-susceptible strains in adults.

Developed by Venus Medicine Research Centre (VMRC), the R&D division of Venus Remedies, VRP-034 is a novel supramolecular cationic (SMC) formulation of polymyxin B sulphate, uniquely developed to address the nephrotoxic effects associated with conventional polymyxin B therapy.

The QIDP designation, granted under the Generating Antibiotic Incentives Now (GAIN) Act, provides VRP-034 with significant regulatory benefits, including priority review, eligibility for fast-track designation, and an additional five years of market exclusivity upon approval in the US.

“Receiving QIDP designation for VRP-034 is a pivotal milestone in our efforts to combat antimicrobial resistance,” said Saransh Chaudhary, CEO, Venus Medicine Research Centre. “QIDP recognition for VRP-034 underscores the urgent global need for safer polymyxin-based therapies and validates the strength of our scientific approach.”