Wockhardt announced that its new intravenous antibiotic Foviscu® (WCK 4282) has met the primary endpoint in a Phase 3 clinical trial involving patients with complicated urinary tract infections (cUTI) and acute pyelonephritis caused by Gram-negative bacteria, including extended-spectrum β-lactamase (ESBL)-producing organisms. ESBL enzymes are a major contributor to hospital-acquired infections, as they can render several commonly used antibiotics ineffective and increase treatment difficulty.
With this Phase 3 success, Foviscu® becomes the fifth proprietary antibiotic from Wockhardt to complete a registration-enabling Phase 3 study. The company said this further strengthens its position in antibiotic discovery and development, following earlier products including Emrok®, Emrok O®, Miqnaf®, and Zaynich®.
The Phase 3 trial was designed as a randomized, double-blind study and directly compared Foviscu® against meropenem, a carbapenem antibiotic widely considered a critical last-resort treatment for severe drug-resistant Gram-negative infections. At the Test-of-Cure assessment, Foviscu® reported a clinical cure rate of 93.23%, compared with 92.31% in the meropenem arm. Wockhardt said the results met the trial’s primary endpoint and showed therapeutic equivalence, with a safety profile described as similarly well tolerated. The company also noted that this is the first Phase 3 head-to-head trial of an antibiotic specifically developed for ESBL infections against meropenem.
The company highlighted growing concerns in India around ESBL prevalence and increasing resistance to commonly prescribed antibiotic combinations such as piperacillin/tazobactam and cefoperazone/sulbactam. With resistance levels rising, clinicians are increasingly relying on carbapenems like meropenem, which in turn increases the risk of accelerating carbapenem resistance. Wockhardt stated that by offering an effective alternative for ESBL infections, Foviscu® could help reduce carbapenem dependence and support stronger antibiotic stewardship efforts to slow antimicrobial resistance. The company noted that India currently uses an estimated 65 lakh annual treatment courses of meropenem, piperacillin/tazobactam, and cefoperazone/sulbactam.
WCK 4282 was evaluated through a combined Phase 2 and Phase 3 program enrolling 323 hospitalized cUTI and acute pyelonephritis patients. Key pathogens included E. coli, Klebsiella species, Enterobacter species, and Pseudomonas species. Wockhardt reported that 51.4% of Enterobacterales isolates were ESBL-positive, and 33.8% of Gram-negative isolates showed cefepime resistance, reinforcing the demand for stronger first-line options.
Wockhardt stated that Foviscu® is the only scientifically developed single-vial dosage form combining clinically validated and pharmacodynamically optimized doses of tazobactam 2 g and cefepime 2 g, supported by proprietary technology aimed at ensuring safety. The drug has been studied through a global development program including clinical trials, pharmacokinetics/pharmacodynamics studies, antimicrobial testing methods, and microbiology evaluation.
WCK 4282 has also received Qualified Infectious Disease Product (QIDP) designation from the US FDA. The combined Phase 2/3 trial received partial support from the National Biopharma Mission under the Department of Biotechnology, Government of India.
Wockhardt has spent over 27 years building a focused antibiotic discovery program targeting drug-resistant pathogens. Its pipeline includes six antibiotics at different stages of development, all of which have received Qualified Infectious Disease Product designation from the US FDA. The company employs around 2,900 people across multiple countries, with manufacturing and research facilities in India, the UK, and Ireland, and derives a significant portion of its revenue from international markets.
