
Prestigious Medical Journal Publishes Pivotal Phase 3 Clinical Study on Wockhardt's Novel Antibiotic Miqnaf®
The Lancet Regional Health Southeast Asia has published the full results of the pivotal Phase 3 clinical study of Wockhardt's novel antibiotic Miqnaf® (nafithromycin) for the treatment of community-acquired bacterial pneumonia (CABP). This is the first-ever publication in a LANCET journal for a novel drug discovered and developed in India, underlining the global relevance and scientific rigor of this study. Miqnaf®, the first new macrolide antibiotic in over three decades, offers a convenient once-daily, three-day oral treatment regimen, a significant step toward improving compliance, minimizing hospitalization, and enhancing patient outcomes. The Phase 3 study demonstrated Miqnaf®’s non-inferior efficacy, with clinical improvement observed in >90% of patients as little as 3-4 days from treatment initiation. The drug has gained Qualified Infectious Disease Product designation by US FDA.
Key Highlights
- First-ever publication in a LANCET journal for a novel drug discovered and developed in India
- Miqnaf® is the first new macrolide antibiotic in over three decades
- Offers a convenient once-daily, three-day oral treatment regimen
- Demonstrated non-inferior efficacy in Phase 3 clinical study
- Gained Qualified Infectious Disease Product designation by US FDA