Wockhardt has announced that its novel intravenous antibiotic Foviscu® (WCK 4282) has successfully met the primary endpoint in a Phase 3 clinical trial involving patients with complicated urinary tract infections (cUTI) and acute pyelonephritis (AP) caused by Gram-negative bacteria, including extended-spectrum β-lactamase (ESBL)-producing pathogens. ESBL enzymes render many commonly used antibiotics ineffective and remain a major driver of difficult-to-treat hospital-acquired infections.
Strengthening Wockhardt’s Leadership in Antibiotic Discovery
With this achievement, Foviscu® becomes the fifth proprietary antibiotic from Wockhardt to complete a registration-enabling Phase 3 study, following Emrok®, Emrok O®, Miqna®, and Zaynich®. Collectively, these milestones reinforce Wockhardt’s long-standing leadership in the discovery and development of novel antibiotics targeting multidrug-resistant infections.
Head-to-Head Phase 3 Study Against Meropenem
In a randomized, double-blind Phase 3 trial, researchers directly compared Foviscu® with meropenem, a last-line carbapenem widely used for severe drug-resistant Gram-negative infections. At the Test-of-Cure visit, Foviscu® achieved a clinical cure rate of 93.23%, compared with 92.31% for meropenem, thereby meeting the primary endpoint and demonstrating therapeutic equivalence.
Importantly, both treatments showed comparable and well-tolerated safety profiles. Notably, this study represents the first Phase 3 head-to-head trial of an antibiotic specifically developed for ESBL infections against meropenem.
Addressing the Growing Burden of Antimicrobial Resistance in India
Data from the Indian Council of Medical Research (ICMR) highlight a high burden of ESBL-producing organisms in India, along with rising resistance to commonly used antibiotics such as piperacillin/tazobactam and cefoperazone/sulbactam. As a result, clinicians increasingly rely on carbapenems like meropenem, accelerating the emergence of carbapenem resistance.
By offering an effective alternative, Foviscu® has the potential to reduce carbapenem dependence and strengthen antibiotic stewardship efforts aimed at curbing antimicrobial resistance. Currently, approximately 6.5 million treatment courses of meropenem, piperacillin/tazobactam, and cefoperazone/sulbactam are used annually in India, underscoring the urgent need for new first-line options.
Robust Clinical Evidence from Phase 2 and Phase 3 Trials
As per the press release, Foviscu® underwent a combined Phase 2 and Phase 3 clinical development program, enrolling 323 hospitalized patients with cUTI and AP (Phase 2: 60 patients; Phase 3: 263 patients). The most frequently identified pathogens included Escherichia coli, Klebsiella spp., Enterobacter spp., and Pseudomonas spp.
Notably, 51.4% of Enterobacterales isolates were ESBL-positive, while 33.8% of Gram-negative isolates showed resistance to cefepime, highlighting the pressing need for more potent and reliable treatment options in high-resistance settings such as India.
About Foviscu® (WCK 4282)
Foviscu® is the only globally developed single-vial formulation that combines pharmacodynamically optimised and clinically validated doses of cefepime (2 g) and tazobactam (2 g). Wockhardt’s proprietary technology enables this combination while maintaining safety and stability.
The antibiotic has undergone extensive evaluation through a comprehensive global development program encompassing clinical trials, pharmacokinetics and pharmacodynamics (PK/PD), antimicrobial susceptibility testing, and microbiological studies. Phase 1 and renal impairment studies were conducted in The Netherlands, PK/PD studies in the United States, Europe, and India, and microbiology studies on global bacterial isolates in the US and India.
Furthermore, multiple peer-reviewed publications in leading international journals have documented its strong activity against ESBL-producing pathogens. The US Food and Drug Administration (FDA) has granted WCK 4282 Qualified Infectious Disease Product (QIDP) designation. The combined Phase 2/3 trial also received partial support from the National Biopharma Mission, an initiative of the Department of Biotechnology, Government of India.
Wockhardt’s Commitment to Novel Anti-Infective Innovation
Over the past 25 years, Wockhardt has consistently focused its drug discovery efforts on developing novel therapies for multidrug-resistant infections. As a result, the company has built a robust portfolio of six products at various stages of clinical development and commercialisation. Each of these products has received QIDP designation from the US FDA, underscoring Wockhardt’s sustained contribution to addressing one of the most critical challenges in global healthcare.