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Pharmaceuticals
New Launch25 Sept 2025, 04:16 pm

Prestigious Medical Journal Publishes Pivotal Phase 3 Clinical Study on Wockhardt's Novel Antibiotic Miqnaf®

AI Summary

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
WOCKPHARMA
Pharmaceuticals
WOCKHARDT LTD.

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