Wockhardt’s Novel Antibiotic Foviscu Matches Meropenem in Pivotal Phase 3 Trial, Strengthening Fight Against Drug Resistance

Mumbai, January 27, 2026 – Wockhardt Limited (BSE: 532300 | NSE: WOCKPHARMA) on Tuesday announced a major clinical milestone with its novel intravenous antibiotic Foviscu (WCK 4282) successfully meeting the primary endpoint in a pivotal Phase 3 trial, demonstrating therapeutic equivalence with the widely used gold-standard antibiotic meropenem.

Phase 3 Trial Highlights​

Foviscu was evaluated in patients suffering from complicated urinary tract infections and acute pyelonephritis caused by Gram-negative bacteria, including extended-spectrum beta-lactamase producing pathogens. These infections are among the most challenging to treat in hospital settings due to rising resistance to commonly prescribed antibiotics.

In a randomized, double-blind Phase 3 study, Foviscu was directly compared with meropenem. At the test-of-cure assessment, Foviscu recorded a clinical cure rate of 93.23 percent, marginally higher than 92.31 percent achieved by meropenem, confirming comparable efficacy with a similar safety profile. The trial marks the first Phase 3 head-to-head comparison of an antibiotic specifically developed for ESBL infections against meropenem.

Addressing Rising Antimicrobial Resistance​

India continues to witness a high burden of ESBL-producing pathogens, with increasing resistance to commonly used therapies such as piperacillin-tazobactam and cefoperazone-sulbactam. This trend has pushed clinicians toward greater dependence on carbapenems, accelerating resistance even to last-line treatments.

By offering an effective alternative, Foviscu has the potential to reduce carbapenem usage and support antibiotic stewardship efforts. Currently, an estimated 65 lakh treatment courses of meropenem, piperacillin-tazobactam, and cefoperazone-sulbactam are administered annually in India, underscoring the scale of the clinical opportunity.

Robust Clinical Development Program​

The Foviscu clinical program combined Phase 2 and Phase 3 studies, enrolling 323 hospitalized patients, including 60 in Phase 2 and 263 in Phase 3. The most common pathogens identified were Escherichia coli, Klebsiella species, Enterobacter species, and Pseudomonas species. More than half of the Enterobacterales isolates were ESBL-positive, while over one-third of Gram-negative isolates showed resistance to cefepime, highlighting the urgent need for stronger first-line therapies.

Unique Formulation and Global Evaluation​

Foviscu is designed as a single-vial formulation combining pharmacodynamically optimized doses of tazobactam and cefepime, enabled by proprietary technology aimed at enhancing safety and efficacy. The molecule has undergone extensive global evaluation across clinical development, pharmacokinetics, pharmacodynamics, and microbiological studies conducted in India, Europe, and the United States.

Strengthening Wockhardt’s Antibiotic Portfolio​

With this achievement, Foviscu becomes Wockhardt’s fifth proprietary antibiotic to complete a registration-enabling Phase 3 study, following earlier successes with Emrok, Emrok O, Miqnaf, and Zaynich. The milestone further reinforces the company’s long-standing focus on developing novel treatments for multi-drug resistant infections.

About the Company​

Wockhardt Limited is an India-based pharmaceutical company engaged in research, development, manufacture, and global marketing of pharmaceutical and biotechnology products. Listed on both the BSE and NSE, the company has built a strong presence in antibiotic discovery over more than two decades, with multiple proprietary products at advanced stages of clinical development and commercialization.