Zaynich : A Novel Antibiotic

Zaynich is developed by the Indian pharmaceutical company Wockhardt.

Designed to combat multi-drug resistant (MDR) Gram-negative bacterial infections, which pose a significant threat to global public health.

A patented combination of zidebactam + cefepime, engineered to cover major Gram-negative “superbugs” like Pseudomonas aeruginosa, Acinetobacter baumannii, and carbapenem-resistant
Qualified Infectious Disease Product (QIDP) status granted by the US FDA, recognizing its unmet medical need potential.
Phase III global trials underway for complicated urinary tract infections
Under compassionate use, it has been administered to around 30–50 critical patientsin India and U.S. with 100% success and proven safety even for prolonged use.
India launch expected by end of FY 2024‑25, with global rollout anticipated in FY 2025‑26;
India pricing aims to be ~1/10th of global price.

Candidate	Composition	Target Pathogens	Phase Status	Key Features
Zaynich(WCK 5222)	Zidebactam + Cefepime	Carbapenem-resistant Gram-negative (Enterobacterales, Pseudomonas, Acinetobacter)	Ongoing Phase III (global); India launch FY 2024‑25; global FY 2025‑26	Broad-spectrum; high breakpoint; successful compassionate use
WCK 6777	Ertapenem + Zidebactam	Carbapenem-resistant Gram-negative infections	Completed Phase I; moving to Phase II/III	Once-a-day OPAT; fast-track; reduces hospitalization
WCK 4873 (Miqnaf/ Nafithromycin)	Macrolide-class antibiotic	CABP & pneumonia including resistant S. pneumoniae	Phase III complete; NDA filed in India	Short regimen (3 days); high lung penetration
WCK 771 / WCK 2349 (EMROK/ EMROK O)	Levonadifloxacin IV & oral	MRSA, VISA, VRSA, skin & SSTI	Approved in India; commercial rollout ongoing	IV & switch-to-oral therapy; broad-spectrum MRSA action
WCK 4282	High-dose Cefepime/Tazobactam	ESBL-producing Gram-negatives	Phase II/III initiated June 2024 (~324 patients)	Potential carbapenem-sparing empirical therapy

GS3