Last reviewed · How we verify
Azithromycin Oral Product
Azithromycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, thereby stopping bacterial growth.
Azithromycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, thereby stopping bacterial growth. Used for Community-acquired pneumonia, Acute bacterial sinusitis, Acute otitis media.
At a glance
| Generic name | Azithromycin Oral Product |
|---|---|
| Also known as | Zithromax, Azithrocin |
| Sponsor | Thomas Jefferson University |
| Drug class | Macrolide antibiotic |
| Target | Bacterial 50S ribosomal subunit |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Azithromycin is a macrolide antibiotic that binds to bacterial ribosomal RNA and inhibits peptide translocation, preventing the formation of the initiation complex and halting protein synthesis. This bacteriostatic action allows the immune system to clear the infection. It has a broad spectrum of activity against gram-positive and some gram-negative bacteria, as well as atypical organisms.
Approved indications
- Community-acquired pneumonia
- Acute bacterial sinusitis
- Acute otitis media
- Pharyngitis/tonsillitis
- Uncomplicated skin and soft tissue infections
- Sexually transmitted infections (Chlamydia trachomatis, Neisseria gonorrhoeae)
Common side effects
- Diarrhea
- Nausea
- Abdominal pain
- Vomiting
- QT prolongation
- Hepatotoxicity
- Allergic reactions
Key clinical trials
- Azithromycin Reduction to Reach Elimination of Trachoma (PHASE4)
- Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial (PHASE2)
- A Study of Standard Drugs for Mycobacterium Avium Complex (PHASE2)
- Azithromycin Reduction to Reach Elimination of Trachoma B (PHASE4)
- This Randomized Controlled Trial Evaluates the Comparative Efficacy of Intravenous Meropenem Alone Versus Intravenous Meropenem Combined With Oral Azithromycin in Children Aged 6 Months to Under 5 Years Diagnosed With Blood Culture-confirmed Extensively Drug-resistant Uncomplicated Typhoid Fever (PHASE4)
- BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP) (PHASE2)
- A Single-Dose, Three-Way, Three-Sequence, Crossover BA Study of Azithromycin Oleogel (PHASE1)
- Comparison of Two- Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease (PHASE2, PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Azithromycin Oral Product CI brief — competitive landscape report
- Azithromycin Oral Product updates RSS · CI watch RSS
- Thomas Jefferson University portfolio CI