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Cephalosporins and Macrolide Antibiotics
Cephalosporins and Macrolide Antibiotics is a Small molecule drug developed by Beijing Children's Hospital. It is currently in Phase 2 development. Also known as: azithromycin, erythromycin, cefamandole, latamoxef.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Cephalosporins and Macrolide Antibiotics |
|---|---|
| Also known as | azithromycin, erythromycin, cefamandole, latamoxef, ceftriaxone |
| Sponsor | Beijing Children's Hospital |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
- Urethral Discharge
- NICU admission
- Blood Pressure Increased
- Dysuria
- Vomitting
- Postpartum preeclampsia/readmission
- Headache
- Glycosuria
- Urethritis
- Diarrhoea
- Instillation Site Pain
- Myalgia
Key clinical trials
- 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)
- Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0 (PHASE2)
- Assessing Role of Probiotics in Children Aged 6-36 Months Treated for Pneumonia (NA)
- Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT) (PHASE4)
- Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT) (PHASE3)
- Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (PHASE2, PHASE3)
- Nasal Iodine Swab Versus Oral Antibiotic to Prevent Surgical Site Infection After Undergoing Mohs Micrographic Surgery (NA)
- Urogenital Infections in Women of Reproductive Age and the Activity of 4-Thiazolidinone Derivatives Against Pathogens (PHASE1)
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:
- Cephalosporins and Macrolide Antibiotics CI brief — competitive landscape report
- Cephalosporins and Macrolide Antibiotics updates RSS · CI watch RSS
- Beijing Children's Hospital portfolio CI
Frequently asked questions about Cephalosporins and Macrolide Antibiotics
What is Cephalosporins and Macrolide Antibiotics?
Who makes Cephalosporins and Macrolide Antibiotics?
Is Cephalosporins and Macrolide Antibiotics also known as anything else?
What development phase is Cephalosporins and Macrolide Antibiotics in?
What are the side effects of Cephalosporins and Macrolide Antibiotics?
Related
- Manufacturer: Beijing Children's Hospital — full pipeline
- Also known as: azithromycin, erythromycin, cefamandole, latamoxef, ceftriaxone
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing