NAFITHROMYCIN
Background and Date of Approval
Nafithromycin was developed through a 14-year effort by Wockhardt, involving collaboration across the US, Europe, South Africa, and India, backed by approximately INR 500 crore. It belongs to a new class called lactone-ketolides and aims to address resistant respiratory infections. Phase I trials confirmed safety and pharmacokinetics, followed by Phase II and III studies comparing it to standard antibiotics in adults with community-acquired bacterial pneumonia (CABP). In January 2025, India's CDSCO approved it (marketed as Miqnaf) for adult CABP in a convenient once-daily, 3-day oral course.
Uses
Nafithromycin is used to treat: Communityâacquired bacterial pneumonia Acute bacterial exacerbation of chronic bronchitis Acute bacterial sinusitis Streptococcal pharyngitis/tonsillitis
Side Effects
Common (usually mild and temporary): Mild stomach discomfort or nausea Headache or dizziness Loose stools or mild diarrhoea Temporary skin rash Serious (less common, seek medical help): Severe allergic reactions (swelling, hives, trouble breathing) Irregular heartbeat or feeling of a fast pulse Intense gastrointestinal symptoms (severe cramps, persistent vomiting) Most people tolerate the medicine well, but any unexpected or worsening symptoms should be reported right away.
Warnings
Not to be used by those with known allergy to macrolide or ketolide antibiotics. May interact with strong heart rhythm medicines; check with your doctor. Caution in those with heart rhythm issues; a heart monitor may be needed. Avoid taking certain liverâmetabolism inhibitors, can affect drug levels and safety. Not studied in children or pregnant women, usage in these cases needs medical advice.
Precautions
Before starting, tell your doctor about any heart issues, especially those prone to irregular rhythms, or if you’re using medicines that affect liver enzymes (like certain antifungals or antivirals). The drug builds up in the lungs, so people with liver or kidney problems may need close observation. As with all antibiotics, finish the full prescribed course even if you start to feel better, as this helps fight resistance.
References
https://www.pib.gov.in/PressReleasePage.aspx?PRID=2081506 https://pmc.ncbi.nlm.nih.gov/articles/PMC8210042/ https://www.sciencedirect.com/science/article/pii/S2211715622004763
Frequently Asked Questions
What is the drug Nafithromycin used for?
Nafithromycin is an antibiotic used to treat bacterial respiratory tract infections. It is approved to treat community-acquired bacterial pneumonia (CABP), acute bacterial sinusitis, chronic bronchitis exacerbations, and strep throat in adults. It is effective against drug-resistant bacteria and offers a short, three-day oral treatment.
Which is the first indigenous antibiotic in UPSC?
Nafithromycin is the first indigenously developed antibiotic in India. It was created by Wockhardt after 14 years of research and is a significant milestone in Indian pharmaceutical innovation. This fact is relevant for UPSC and other competitive exams related to healthcare and science.
What is the difference between Nafithromycin and Azithromycin?
Both are antibiotics used for respiratory infections, but Nafithromycin is more effective against certain drug-resistant bacteria. It binds more strongly to bacterial targets and requires only a once-daily, 3-day course. In comparison, azithromycin may need a longer duration and may be less effective in resistant infections.
Is Nafithromycin available in India?
Yes, Nafithromycin is available in India under the brand name Miqnaf. It was approved by the CDSCO in January 2025 for use in adults. It is currently prescribed for community-acquired respiratory infections and comes in a 400 mg oral tablet.