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Biaxin (clarithromycin)
Clarithromycin is a macrolide antimicrobial drug.
Clarithromycin (Biaxin) is a macrolide antibiotic approved in 1991, essential for H. pylori eradication therapy. Available generically worldwide.
At a glance
| Generic name | clarithromycin |
|---|---|
| Also known as | Biaxin, Klacid |
| Sponsor | Generic (originally Abbott/AbbVie) |
| Drug class | Macrolide Antimicrobial [EPC] |
| Target | Potassium voltage-gated channel subfamily H member 2 |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 1991-10-31 (United States) |
Mechanism of action
Clarithromycin is a semi-synthetic macrolide derived from erythromycin with improved acid stability, oral bioavailability, and tissue penetration. It is a key component of H. pylori triple therapy and is also used for respiratory infections, MAC prophylaxis in HIV, and atypical mycobacterial infections.
Approved indications
- Acute Moraxella catarrhalis bronchitis
- Acute bacterial bronchitis
- Acute bacterial sinusitis
- Acute exacerbation of chronic bronchitis
- Acute maxillary sinusitis
- Acute otitis media
- Bacterial pneumonia
- Chlamydial pneumonia
- Duodenal Ulcer due to H. Pylori
- Haemophilus Influenzae Acute Otitis Media
- Haemophilus Influenzae Bronchitis
- Haemophilus Parainfluenzae Pneumonia
- Haemophilus influenzae pneumonia
- Infection caused by Helicobacter pylori
- Infection due to Staphylococcus aureus
- Infection of skin AND/OR subcutaneous tissue
- Infective otitis media
- Moraxella Catarrhalis Acute Otitis Media
- Moraxella Catarrhalis Pneumonia
- Pneumococcal pneumonia
Common side effects
- abdominal pain
- headache
- diarrhea
- dyspepsia
- flatulence
- nausea
- vomiting
- rash
- taste perversion
Key clinical trials
- Isotretinoin in Treatment of COVID-19 (Randomized) (Phase 3)
- Risk of Acute Liver Injury in Users of Antimicrobials in the HealthCore Integrated Research Database Population (N/A)
- A Multi-center, Randomized, Double-blind, Parallel-group, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWP14012-based Triple Therapy in Eradication of Helicobacte (Phase 3)
- Personalized Treatment for Refractory H Pylori Infection (NA)
- Canadian North Helicobacter Pylori (CANHelp) Working Group Treatment Trials (Phase 4)
- A Randomized Trial of Standard vs Half Dose Rabeprazole, Clarithromycin, Metronidazole and Amoxicillin in the Treatment of Helicobacter Pylori Infection (Phase 4)
- Vonoprazan-based Therapy Versus Standard Regimen for Helicobacter Pylori Infection Management (Phase 4)
- The Role of Probiotics in the Eradication of Helicobacter Pylori (NA)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Biaxin CI brief — competitive landscape report
- Biaxin updates RSS · CI watch RSS
- Generic (originally Abbott/AbbVie) portfolio CI