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Standard antibiotic prophylaxis
Standard antibiotic prophylaxis is a Antibiotic (class varies by specific agent) Small molecule drug developed by Western Galilee Hospital-Nahariya. It is currently in Phase 3 development for Surgical site infection prophylaxis, Bacterial infection prevention in high-risk patients.
Standard antibiotic prophylaxis prevents bacterial infections by inhibiting bacterial cell wall synthesis or protein production before infection occurs.
Standard antibiotic prophylaxis is used to prevent infections in various conditions, including recurrent urinary tract infections, type 1 diabetes, islet transplantation, candidemia, and mycoses. The modality of standard antibiotic prophylaxis is a small molecule intervention, as indicated by its classification in ChEMBL.
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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 | Standard antibiotic prophylaxis |
|---|---|
| Sponsor | Western Galilee Hospital-Nahariya |
| Drug class | Antibiotic (class varies by specific agent) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Prophylaxis |
| Phase | Phase 3 |
Mechanism of action
Prophylactic antibiotics are administered prior to surgical procedures or in high-risk patients to prevent surgical site infections and other bacterial complications. The specific mechanism depends on the antibiotic class used (e.g., beta-lactams inhibit cell wall synthesis, aminoglycosides inhibit protein synthesis), but the goal is to achieve sufficient tissue and serum concentrations at the time of potential bacterial exposure to prevent establishment of infection.
Approved indications
- Surgical site infection prophylaxis
- Bacterial infection prevention in high-risk patients
Common side effects
- Allergic reaction / hypersensitivity
- Gastrointestinal disturbance
- Clostridium difficile infection
Key clinical trials
- metaCARpal Bone Osteosynthesis Trail (NA)
- Feasibility Study of Ocular Surface Squamous Neoplasia Surgical Excision in People Living With HIV in Sub-Saharan Africa (NA)
- SHAPE Pilot Trial: Skin Health and Allergy Prevention Exposure (NA)
- Integrating Point of Care Testing (POCT) For Newborn Screening and Early Care for Sickle Cell Disease in Yopougon, Côte d'Ivoire (PHASE4)
- VE303 for Prevention of Recurrent Clostridioides Difficile Infection (PHASE3)
- An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated SAM (PHASE3)
- Regular Home-use of Dual-light Photodynamic Therapy in the Management of Chronic Stage III-IV Periodontitis (NA)
- Dual-Targeting CAR-NK Cells for Recurrent Ovarian Cancer (MSLN, FRα, MUC16) (PHASE1, 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:
- Standard antibiotic prophylaxis CI brief — competitive landscape report
- Standard antibiotic prophylaxis updates RSS · CI watch RSS
- Western Galilee Hospital-Nahariya portfolio CI
Frequently asked questions about Standard antibiotic prophylaxis
What is Standard antibiotic prophylaxis?
How does Standard antibiotic prophylaxis work?
What is Standard antibiotic prophylaxis used for?
Who makes Standard antibiotic prophylaxis?
What drug class is Standard antibiotic prophylaxis in?
What development phase is Standard antibiotic prophylaxis in?
What are the side effects of Standard antibiotic prophylaxis?
Related
- Drug class: All Antibiotic (class varies by specific agent) drugs
- Manufacturer: Western Galilee Hospital-Nahariya — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Prophylaxis
- Indication: Drugs for Surgical site infection prophylaxis
- Indication: Drugs for Bacterial infection prevention in high-risk patients
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing