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BV100 plus Polymyxin B
BV100 plus Polymyxin B is a Antibiotic Small molecule drug developed by BioVersys AG. It is currently in Phase 2 development for Bacterial infections.
BV100 targets the bacterial cell membrane, disrupting its integrity and leading to cell death, in combination with Polymyxin B, an antibiotic that targets the bacterial cell wall.
BV100 targets the bacterial cell membrane, disrupting its integrity and leading to cell death, in combination with Polymyxin B, an antibiotic that targets the bacterial cell wall. Used for Bacterial infections.
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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). -
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 | 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 | BV100 plus Polymyxin B |
|---|---|
| Sponsor | BioVersys AG |
| Drug class | Antibiotic |
| Target | Bacterial cell membrane |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 2 |
Mechanism of action
BV100 is a novel compound that has been shown to have bactericidal activity against a range of Gram-negative bacteria, including those resistant to other antibiotics. When combined with Polymyxin B, it has been shown to be effective against a broad spectrum of bacterial infections.
Approved indications
- Bacterial infections
Common side effects
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)
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 plus Polymyxin B CI brief — competitive landscape report
- BV100 plus Polymyxin B updates RSS · CI watch RSS
- BioVersys AG portfolio CI
Frequently asked questions about BV100 plus Polymyxin B
What is BV100 plus Polymyxin B?
How does BV100 plus Polymyxin B work?
What is BV100 plus Polymyxin B used for?
Who makes BV100 plus Polymyxin B?
What drug class is BV100 plus Polymyxin B in?
What development phase is BV100 plus Polymyxin B in?
What does BV100 plus Polymyxin B target?
Related
- Drug class: All Antibiotic drugs
- Target: All drugs targeting Bacterial cell membrane
- Manufacturer: BioVersys AG — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Bacterial infections
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing