Last reviewed · How we verify
Single shot antibiotic prophylaxis
Single shot antibiotic prophylaxis is a Small molecule drug developed by Onze Lieve Vrouwe Gasthuis. It is currently in Phase 2 development.
Single shot antibiotic prophylaxis is used to prevent Urinary Tract Infections (UTIs) in patients undergoing certain medical procedures, such as bariatric surgery and intradetrusor onabotulinumtoxinA procedures. The antibiotics used for this purpose include nitrofurantoin 100 MG and cefazoline, which are small molecule compounds that act as antimicrobial agents.
-
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 | Single shot antibiotic prophylaxis |
|---|---|
| Sponsor | Onze Lieve Vrouwe Gasthuis |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study (PHASE4)
- Antibiotics for Prevention of Infection Following Orthognathic Surgery (PHASE4)
- Topical Vancomycin for Neurosurgery Wound Prophylaxis (PHASE3)
- Comparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding. (NA)
- HPV Vaccine Reduced Dose (PHASE4)
- Routine Antibiotic vs. Directed Antibiotic Treatment in Snake Bite (PHASE4)
- Pharmacokinetics and Safety of Cefazolin 3gm DUPLEX in Adults (PHASE1)
- Bladder Botox UTI Antibiotic Prophylaxis (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:
- Single shot antibiotic prophylaxis CI brief — competitive landscape report
- Single shot antibiotic prophylaxis updates RSS · CI watch RSS
- Onze Lieve Vrouwe Gasthuis portfolio CI
Frequently asked questions about Single shot antibiotic prophylaxis
What is Single shot antibiotic prophylaxis?
Who makes Single shot antibiotic prophylaxis?
What development phase is Single shot antibiotic prophylaxis in?
Related
- Manufacturer: Onze Lieve Vrouwe Gasthuis — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing