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AZM X mg
AZM X mg is a Macrolide antibiotic Small molecule drug developed by Celltrion. It is currently in Phase 3 development for Community-acquired pneumonia, Chronic bronchitis, Acute exacerbations of chronic obstructive pulmonary disease (COPD).
Azithromycin is a macrolide antibiotic that inhibits protein synthesis by binding to the 50S ribosomal subunit.
AZM X mg is a small molecule used in a clinical study to treat Essential Hypertension. The study, conducted by Celltrion, compares the efficacy and safety of AZM X mg combined with different doses of AML (MG-S-2525) to AZM X' mg combined with AML Y mg.
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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 | AZM X mg |
|---|---|
| Sponsor | Celltrion |
| Drug class | Macrolide antibiotic |
| Target | 50S ribosomal subunit |
| Modality | Small molecule |
| Therapeutic area | Infectious diseases |
| Phase | Phase 3 |
Mechanism of action
Azithromycin works by binding to the 50S ribosomal subunit of bacteria, which prevents the formation of peptide bonds and ultimately inhibits protein synthesis. This leads to the death of the bacterial cell. Azithromycin is effective against a wide range of bacteria, including Gram-positive and Gram-negative bacteria.
Approved indications
- Community-acquired pneumonia
- Chronic bronchitis
- Acute exacerbations of chronic obstructive pulmonary disease (COPD)
Common side effects
- Nausea
- Diarrhea
- Abdominal pain
Key clinical trials
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:
- AZM X mg CI brief — competitive landscape report
- AZM X mg updates RSS · CI watch RSS
- Celltrion portfolio CI
Frequently asked questions about AZM X mg
What is AZM X mg?
How does AZM X mg work?
What is AZM X mg used for?
Who makes AZM X mg?
What drug class is AZM X mg in?
What development phase is AZM X mg in?
What are the side effects of AZM X mg?
What does AZM X mg target?
Related
- Drug class: All Macrolide antibiotic drugs
- Target: All drugs targeting 50S ribosomal subunit
- Manufacturer: Celltrion — full pipeline
- Therapeutic area: All drugs in Infectious diseases
- Indication: Drugs for Community-acquired pneumonia
- Indication: Drugs for Chronic bronchitis
- Indication: Drugs for Acute exacerbations of chronic obstructive pulmonary disease (COPD)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing