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BV100 (300 mg)
BV100 (300 mg) is a Benzoxaborole antibiotic Small molecule drug developed by BioVersys SAS. It is currently in Phase 3 development for Serious bacterial infections caused by resistant gram-negative organisms (Phase 3 development). Also known as: Rifabutin for Infusion.
BV100 is a benzoxaborole antibiotic that inhibits bacterial leucyl-tRNA synthetase, disrupting protein synthesis in susceptible pathogens.
BV100 is a small molecule (modality) with the synonym MG-S-2525, used in clinical trials for various bacterial infections, including Ventilator Associated Pneumonia, Ventilator Associated Bacterial Pneumonia, Hospital Acquired Bacterial Pneumonia, Blood Stream Infection, and Meningitis. It has been studied in combination with other antibiotics, such as polymyxin B and ceftazidime/avibactam, in clinical trials.
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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 | BV100 (300 mg) |
|---|---|
| Also known as | Rifabutin for Infusion |
| Sponsor | BioVersys SAS |
| Drug class | Benzoxaborole antibiotic |
| Target | Leucyl-tRNA synthetase (LeuRS) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Benzoxaboroles are a novel class of boron-containing compounds that bind to the editing site of leucyl-tRNA synthetase, preventing the aminoacylation of tRNA and thus blocking bacterial protein synthesis. This mechanism is distinct from conventional antibiotics and may provide activity against drug-resistant organisms. BV100 is being developed for serious bacterial infections, particularly those caused by resistant gram-negative pathogens.
Approved indications
- Serious bacterial infections caused by resistant gram-negative organisms (Phase 3 development)
Common side effects
- Gastrointestinal disturbances
- Headache
- Nausea
Key clinical trials
- Safety, Pharmacokinetics and Efficacy of BV100 Plus Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol in Patients With Pulmonary and Extrapulmonary Infections Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex (PHASE2)
- Efficacy and Safety of BV100 Plus Low Dose Polymyxin B Versus Colistin Plus High-dose Ampicillin/Sulbactam in Patients With Hospital-acquired or Ventilator-associated Bacterial Pneumonia Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex (PHASE3)
- PK of BV100 in Patients VABP Suspected or Confirmed to Be Due to CRAB (PHASE2)
- To Evaluate the Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of BV100 (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:
- BV100 (300 mg) CI brief — competitive landscape report
- BV100 (300 mg) updates RSS · CI watch RSS
- BioVersys SAS portfolio CI
Frequently asked questions about BV100 (300 mg)
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Related
- Drug class: All Benzoxaborole antibiotic drugs
- Target: All drugs targeting Leucyl-tRNA synthetase (LeuRS)
- Manufacturer: BioVersys SAS — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Serious bacterial infections caused by resistant gram-negative organisms (Phase 3 development)
- Also known as: Rifabutin for Infusion
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing