Drug intelligence / Profile preview

nafithromycin

Development stage
Phase 2
Lead developer
Wockhardt
Modality
RNA-Targeting Small Molecules → Nucleic Acid-Directed Small Molecules → Small Molecules
Administration
Oral
01

Overview

Nafithromycin is a next-generation macrolide antibiotic, specifically a novel lactone-ketolide, developed to address infections caused by both typical and atypical drug-resistant bacteria. It is the first new antibiotic in its class introduced globally in over 30 years and was developed indigenously in India. Nafithromycin exhibits a dual binding mechanism to the bacterial 50S ribosomal subunit, inhibiting protein synthesis by blocking the elongation of the peptide chain during translation. This action disrupts bacterial growth and replication, resulting in either bacteriostatic or bactericidal effects depending on concentration and organism. The drug demonstrates potent activity against multidrug-resistant respiratory pathogens—including penicillin- and macrolide-resistant Streptococcus pneumoniae—and has shown efficacy ten times greater than azithromycin with a three-day treatment regimen. Clinical trials have validated its superior safety profile, minimal side effects (notably low gastrointestinal disturbance), no significant drug interactions, and unaffected absorption by food intake. Nafithromycin is primarily indicated for community-acquired bacterial pneumonia (CABP) but also shows promise for other respiratory tract infections.

Brand names
Miqnaf
Other names
nafithromycin
02

Targets

Bacterial 50S ribosomal subunit

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