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Azythromycin
Azythromycin is a Small molecule drug developed by Institut Pasteur. It is currently in Phase 3 development. Also known as: Antibiotics.
Azythromycin is a small molecule that inhibits the bacterial 70S ribosome, classified as a bacterial 70S ribosome inhibitor. It is used to treat various conditions, including cystic fibrosis, as indicated by clinical trials on ClinicalTrials.gov.
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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).
| 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 | Azythromycin |
|---|---|
| Also known as | Antibiotics |
| Sponsor | Institut Pasteur |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
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:
- Azythromycin CI brief — competitive landscape report
- Azythromycin updates RSS · CI watch RSS
- Institut Pasteur portfolio CI
Frequently asked questions about Azythromycin
What is Azythromycin?
Who makes Azythromycin?
Is Azythromycin also known as anything else?
What development phase is Azythromycin in?
Related
- Manufacturer: Institut Pasteur — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Antibiotics
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing