Drug maker Wockhardt will go solo in marketing Zaynich, the company’s novel antibiotic that has received regulatory approval in the United States – a first for a new chemical entity developed from India, its Founder and Chairman, Habil Khorakiwala, said.

The company recently received a green signal from the United States Food and Drug Administration (USFDA) for Zaynich (cefepime and zidebactam), an intravenous antibiotic to treat adults with complicated urinary tract infections (cUTI).

But unlike the usual modus operandi in pharmaceuticals to partner for global distribution, Wockhardt will market the drug in international markets and India on its own, Khorakiwala said in a select media interaction.

The USFDA approval for an Indian NCE marks a milestone for the company and for the Indian industry, he said. It was also significant given the prevalence of antimicrobial resistance across the world, and the exit of multinational companies from the antibiotics segment, he added. The addressable antibiotic segment is about $9 billion, according to industry estimates. The peak annual sales potential of the drug is about 1.5 billion, he said.

Lauding the work of his scientific team and the two-decade-plus journey, Khorakiwala said they were setting up a business operation in the US to support the product’s marketing. Manufacturing will be done by a third-party entity in Italy, he added. The company has spent about $ 800 million in researching its antibiotic pipeline with six candidates, Khorakiwala told businessline.

Wockhardt also received the Drug Controller General of India’s approval for Zaynich last week. Khorakiwala expected to roll out the product in the US later this calendar year or early next year. The launch in India is expected later this year, he said. Wockhardt has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency, it added.

Dennis Deruelle, Wockhardt Chief Medical Officer, said, “The threat of drug-resistant infections is an escalating crisis, leaving clinicians with fewer tools to treat patients facing these aggressive pathogens.”

Trial details

Zaynich (cefepime and zidebactam) is an injectable antibiotic comprising cefepime, a cephalosporin antibacterial drug and zidebactam, a non-β-lactam antibacterial and β-lactamase inhibitor, the company said. In the US, Zaynich had received the Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA. It was also made available through expanded access programmes in multiple countries, including the US, for patients with limited treatment options, the company said.

The FDA approval was based, in part, on the results from ENHANCE-1, a Phase 3, randomised, double-blind, multicenter study which evaluated the efficacy, safety and tolerability of Zaynich, compared with meropenem in the treatment of hospitalised adults with cUTI or acute pyelonephritis (AP), it said. The study enrolled 530 patients from the US, Europe, LATAM, China and India, and spanned across 64 sites.

The product is contraindicated in patients with a known history of serious hypersensitivity to the components of Zaynich (cefepime and zidebactam) or other beta-lactam antibacterial drugs, the company said, citing adverse events.

Unlike most other beta-lactam combinations, Zaynich targets multiple penicillin-binding proteins (PBP 1a/b, 2 and 3) simultaneously, a note from the company said. “This unique, multi-target synergy provides bactericidal activity against the most challenging drug-resistant Gram-negative bacteria for which there are currently very limited treatment options,” it added.

cUTI is responsible for over 600,000 hospitalisations in the US annually, Wockhardt said. And a growing number of cUTIs are caused by antimicrobial-resistant bacteria, including multidrug-resistant bacteria, a leading cause of bacteremia, associated with significant morbidity and mortality and a burden on the health care system.

Published on June 1, 2026