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azithromycin (Zithromax)
azithromycin (Zithromax) is a Macrolide antibiotic Small molecule drug developed by Pfizer. It is currently in Phase 3 development for Community-acquired pneumonia, Acute bacterial sinusitis, Acute otitis media. Also known as: Zithromax.
Azithromycin is a macrolide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit.
Azithromycin is a macrolide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit. Used for Community-acquired pneumonia, Acute bacterial sinusitis, Acute otitis media.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline. -
Big-pharma sponsor
+3.0pp
Pfizer is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | azithromycin (Zithromax) |
|---|---|
| Also known as | Zithromax |
| Sponsor | Pfizer |
| Drug class | Macrolide antibiotic |
| Target | Bacterial 50S ribosomal subunit |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Azithromycin binds to the bacterial 50S ribosomal subunit and inhibits transpeptidation and translocation, thereby preventing peptide bond formation and halting protein synthesis. This bacteriostatic action is effective against a broad spectrum of gram-positive and gram-negative bacteria, as well as atypical organisms. The drug accumulates in tissues and has a long half-life, allowing for convenient dosing regimens.
Approved indications
- Community-acquired pneumonia
- Acute bacterial sinusitis
- Acute otitis media
- Pharyngitis/tonsillitis
- Uncomplicated skin and soft tissue infections
- Sexually transmitted infections (chlamydia, gonorrhea)
Common side effects
- Diarrhea
- Nausea
- Abdominal pain
- Vomiting
- QT prolongation
- Hepatotoxicity
- Allergic reactions
Key clinical trials
- Improving Care Through Azithromycin Research for Infants in Africa (PHASE3)
- A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction (PHASE3)
- Azithromycin Reduction to Reach Elimination of Trachoma (PHASE4)
- Intra-nodal Injection of Gentamicin for the Treatment of Suppurated Cat Scratch Disease's Lymphadenitis (PHASE3)
- 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)
- An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated SAM (PHASE3)
- Antibiotic Treatment of Recurrent Episodes of Asthma in Children (PHASE2)
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 (Zithromax) CI brief — competitive landscape report
- azithromycin (Zithromax) updates RSS · CI watch RSS
- Pfizer portfolio CI
Frequently asked questions about azithromycin (Zithromax)
What is azithromycin (Zithromax)?
How does azithromycin (Zithromax) work?
What is azithromycin (Zithromax) used for?
Who makes azithromycin (Zithromax)?
Is azithromycin (Zithromax) also known as anything else?
What drug class is azithromycin (Zithromax) in?
What development phase is azithromycin (Zithromax) in?
What are the side effects of azithromycin (Zithromax)?
What does azithromycin (Zithromax) target?
Related
- Drug class: All Macrolide antibiotic drugs
- Target: All drugs targeting Bacterial 50S ribosomal subunit
- Manufacturer: Pfizer — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Community-acquired pneumonia
- Indication: Drugs for Acute bacterial sinusitis
- Indication: Drugs for Acute otitis media
- Also known as: Zithromax
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing