US FDA grants Qualified Infectious Disease Product designation to Venus Remedies’ VRP-034, a novel polymyxin B formulation
- Sub Editor
- Apr 17
- 3 min read
VRP-034 is a novel supramolecular cationic (SMC) formulation of polymyxin B sulphate, uniquely developed to mitigate the nephrotoxic effects associated with conventional polymyxin B (PMB) therapy
Key preclinical findings for VRP-034 included up to 70% reduction in nephrotoxicity compared to marketed PMB
The QIDP designation by the United States Food and Drug Administration (US FDA) underscores the urgent global need for safer polymyxin-based therapies
Venus Remedies Limited (NSE: VENUSREM, BSE: 526953), a leading pharmaceutical company specialising in critical care injectables, today 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 United States.
“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.”
Venus Remedies’ has developed the novel polymyxin-B formulation, VRP-034, using its proprietary Renal Guard technology. The company utilised kidney-on-a-chip technology (based on Organ-on-a-Chip model) to study established kidney injury biomarkers, including KIM-1, cystatin C, NAG, and NGAL, in response to polymyxin-B, an antibiotic used against multidrug-resistant Gram-negative bacteria. These insights directly contributed to the refining of its Renal Guard technology, forming the foundation of the novel formulation, VRP-034, designed specifically to minimise nephrotoxicity while preserving therapeutic efficacy.
Polymyxins, particularly PMB and colistin, are among the last-resort antibiotics used against Multidrug resistance (MDR) infections. However, their clinical use is severely limited by nephrotoxicity, which affects up to 60% of patients. VRP-034 offers a novel solution by preserving the pharmacokinetics and pharmacodynamics of PMB while significantly reducing oxidative stress and renal cell injury, as demonstrated in multiple in vitro and in vivo studies.
\Key preclinical findings for VRP-034 include:
Up to 70% reduction in nephrotoxicity compared to marketed PMB
Robust efficacy against resistant pathogens in both in vitro and animal models
Favourable safety profile across multiple toxicity studies using advanced renal biomarkers and human organ-on-a-chip models
This recognition by the US FDA strengthens Venus Remedies’ commitment to innovation in the fight against AMR and underlines the company’s dedication to addressing unmet needs in infectious disease therapy.
About Venus Remedies Ltd
Panchkula-based Venus Remedies Ltd (NSE: VENUSREM, BSE: 526953) is among the 10 leading fixed-dosage injectable manufacturers in the world. Having a commercial presence in 90+ countries with a portfolio of 75 products spread over Europe, Australia, Africa, Asia-Pacific, Commonwealth States, the Middle East, Latin America and the Caribbean region, the company has nine globally benchmarked facilities in Panchkula, Baddi and Werne (Germany), apart from 11 overseas marketing offices. The company holds the GMP approvals from European- GMP (INFARMED), PIC/S (Malaysia & Ukraine), SAHPRA, UNICEF, TGA, INVIMA & WHO-GMP, alongside key ISO certifications for quality, environmental, and occupational health and safety management.
Central to its mission, Venus Remedies is a frontrunner in combating antimicrobial resistance (AMR) through its dedicated research division, Venus Medicine Research Centre (VMRC). The company is pivotal in developing advanced antibiotics and ⭬actam/⭬actamase inhibitor combinations aimed at tackling multidrug-resistant pathogens. Its notable initiatives like GASAR provide essential data on antibiotic resistance, while the PLEA Trust fosters antibiotic stewardship. As an influential member of the AMR Industry Alliance, India AMR Innovation Hub, and Vivli AMR Registry, Venus Remedies shapes global AMR research and policy. Through strategic collaborations with academic and health organisations worldwide, the company enhances AMR surveillance and supports innovative drug development, affirming its leadership in global healthcare.
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