India Pharma Outlook Team | Thursday, 29 January 2026
Wockhardt today announced a major clinical milestone as Foviscu (WCK 4282) met its primary endpoint in a Phase 3 trial involving patients with complicated urinary tract infections and acute pyelonephritis.
The study focused on infections caused by Gram-negative bacteria, including hard-to-treat extended-spectrum β-lactamase producers. With ESBL enzymes driving hospital-acquired infections worldwide, Wockhardt Foviscu Phase 3 results come at a critical time.
The randomized, double-blind study directly compared Foviscu with meropenem, a carbapenem widely used as a last-resort antibiotic. At the Test-of-Cure stage, Foviscu achieved a clinical cure rate of 93.23%, closely matching 92.31% in the meropenem arm.
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Wockhardt said the trial met its primary endpoint, showed therapeutic equivalence, and confirmed similar tolerability between both treatments. The company noted this as the first Phase 3 head-to-head study of an antibiotic developed specifically for ESBL infections against meropenem.
With this success, Foviscu becomes Wockhardt’s fifth proprietary antibiotic to complete a registration-enabling Phase 3 study, following Emrok, Emrok O, Miqnaf, and Zaynich. The company highlighted rising ESBL prevalence in India and growing resistance to commonly used combinations such as piperacillin/tazobactam and cefoperazone/sulbactam.
India currently uses around 65 lakh annual treatment courses of these agents and carbapenems. By offering an effective alternative, Wockhardt Foviscu Phase 3 data suggests the drug could reduce carbapenem dependence and support stronger antibiotic stewardship.
The combined Phase 2/3 program enrolled 323 hospitalized patients. Foviscu is a single-vial formulation combining optimized doses of cefepime 2 g and tazobactam 2 g, supported by proprietary technology. The drug has received US FDA QIDP designation, with partial funding from the National Biopharma Mission.
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