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Azithromycin on Day 1
Azithromycin on Day 1 is a Macrolide antibiotic Small molecule drug developed by Lihir Medical Centre. It is currently in Phase 3 development for Bacterial respiratory tract infections (community-acquired pneumonia, bronchitis), Sexually transmitted infections (chlamydia, gonorrhea), Skin and soft tissue infections. Also known as: Zithromax.
Azithromycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, preventing peptide bond formation and halting bacterial growth.
Azithromycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, preventing peptide bond formation and halting bacterial growth. Used for Bacterial respiratory tract infections (community-acquired pneumonia, bronchitis), Sexually transmitted infections (chlamydia, gonorrhea), Skin and soft tissue infections.
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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.
| 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 on Day 1 |
|---|---|
| Also known as | Zithromax |
| Sponsor | Lihir Medical Centre |
| Drug class | Macrolide antibiotic |
| Target | Bacterial 50S ribosomal subunit |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Azithromycin is a macrolide antibiotic that binds irreversibly to the bacterial 50S ribosomal subunit, blocking translocation of peptides and inhibiting protein synthesis. This bacteriostatic action prevents bacterial replication and allows the immune system to clear the infection. It also has immunomodulatory properties that may reduce inflammation in certain respiratory conditions.
Approved indications
- Bacterial respiratory tract infections (community-acquired pneumonia, bronchitis)
- Sexually transmitted infections (chlamydia, gonorrhea)
- Skin and soft tissue infections
- Otitis media
Common side effects
- Nausea
- Diarrhea
- Abdominal pain
- Vomiting
- QT prolongation
- Hepatotoxicity
Key clinical trials
- Azithromycin Reduction to Reach Elimination of Trachoma (PHASE4)
- An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated SAM (PHASE3)
- Azithromycin Reduction to Reach Elimination of Trachoma B (PHASE4)
- Scrub Typhus Antibiotic Resistance Trial (PHASE4)
- Doxycycline vs. Macrolide for MRMP (DOMINO) (PHASE4)
- Periodic Presumptive Treatment vs. doxyPEP for STI Control in Kenyan MSM (PHASE4)
- Effects of Different Antibiotic Regimens in Preterm Premature Rupture of Membranes (NA)
- Effect of Antibiotics on Gut Microbiome and Plasma Metabolome (PHASE4)
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 on Day 1 CI brief — competitive landscape report
- Azithromycin on Day 1 updates RSS · CI watch RSS
- Lihir Medical Centre portfolio CI
Frequently asked questions about Azithromycin on Day 1
What is Azithromycin on Day 1?
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Is Azithromycin on Day 1 also known as anything else?
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Related
- Drug class: All Macrolide antibiotic drugs
- Target: All drugs targeting Bacterial 50S ribosomal subunit
- Manufacturer: Lihir Medical Centre — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Bacterial respiratory tract infections (community-acquired pneumonia, bronchitis)
- Indication: Drugs for Sexually transmitted infections (chlamydia, gonorrhea)
- Indication: Drugs for Skin and soft tissue infections
- Also known as: Zithromax
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing