New Launch27 Jan 2026, 09:03 am
Wockhardt's Novel Antibiotic, Foviscu®, Matches Gold-Standard Meropenem in Phase 3 Trial
AI Summary
Wockhardt Limited announced that its novel intravenous antibiotic Foviscu® (WCK 4282) has successfully met the primary endpoint in a Phase 3 clinical trial. The trial compared Foviscu® with meropenem, a 'last-line' gold-standard carbapenem, in patients with complicated urinary tract infections (CUTI) and acute pyelonephritis caused by Gram-negative bacteria. Foviscu® demonstrated therapeutic equivalence with a similarly well-tolerated safety profile, potentially reducing carbapenem use and strengthening antibiotic stewardship. The antibiotic has been extensively evaluated and has been granted QIDP designation by the US FDA.
Key Highlights
- Foviscu® successfully met the primary endpoint in a Phase 3 clinical trial
- Foviscu® demonstrated therapeutic equivalence with meropenem
- Foviscu® has potential to reduce carbapenem use and strengthen antibiotic stewardship
- Foviscu® has been granted QIDP designation by the US FDA
- Wockhardt has a portfolio of 6 products at various stages of clinical development and commercialization, all granted QIDP status by the US FDA