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OM-85 BV (Broncho-Vaxom)
OM-85 BV is an immunostimulant derived from bacterial lysates that enhances innate and adaptive immune responses to reduce respiratory tract infections.
OM-85 BV is a bacterial lysate immunostimulant that enhances innate and adaptive immune responses to reduce respiratory tract infections. Used for Recurrent acute respiratory tract infections, Chronic bronchitis with recurrent infections, Prophylaxis of respiratory infections in immunocompromised patients.
At a glance
| Generic name | OM-85 BV (Broncho-Vaxom) |
|---|---|
| Also known as | Bronchovaxom 3.5 mg capsule |
| Sponsor | Kecioren Education and Training Hospital |
| Drug class | Bacterial lysate immunostimulant |
| Modality | Small molecule |
| Therapeutic area | Immunology / Respiratory |
| Phase | FDA-approved |
Mechanism of action
OM-85 BV contains a standardized lysate of eight common respiratory pathogens (Streptococcus pneumoniae, Streptococcus pyogenes, Staphylococcus aureus, Klebsiella pneumoniae, Klebsiella ozaenae, Haemophilus influenzae, Branhamella catarrhalis, and Neisseria catarrhalis). It stimulates mucosal and systemic immunity by activating dendritic cells and promoting T-cell and B-cell responses, thereby improving the body's ability to prevent and combat respiratory infections.
Approved indications
- Prevention of recurrent respiratory tract infections
- Chronic bronchitis and recurrent sinusitis
Common side effects
- Gastrointestinal disturbances (nausea, diarrhea)
- Mild fever
- Headache
Key clinical trials
- OM-85 in Paediatric Recurrent Respiratory Tract Infections With Wheezing Lower Respiratory Illness (PHASE4)
- A Study to Assess the Efficacy and Safety of Daily OM-85 in Young Children With Recurrent Wheezing (PHASE2)
- Oral Bacterial Extract for the Prevention of Wheezing Lower Respiratory Tract Illness (PHASE2)
- Bacterial Lysate In Preventing Asthma (PHASE2)
- OM 85 to Prevent Respiratory Infections in Older At Risk Patients (PHASE4)
- PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study (PHASE2)
- OM 85 to Prevent Respiratory Infections in Older At Risk Patients (PHASE4)
- Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates. (PHASE3)
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:
- OM-85 BV (Broncho-Vaxom) CI brief — competitive landscape report
- OM-85 BV (Broncho-Vaxom) updates RSS · CI watch RSS
- Kecioren Education and Training Hospital portfolio CI