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Broncho-Vaxom
Broncho-Vaxom is an oral immunostimulant that enhances innate and adaptive immune responses to prevent recurrent respiratory tract infections.
Broncho-Vaxom is an oral immunostimulant that enhances innate and adaptive immune responses to prevent recurrent respiratory tract infections. Used for Recurrent respiratory tract infections (sinusitis, otitis media, bronchitis, pneumonia), Chronic obstructive pulmonary disease (COPD) with recurrent exacerbations.
At a glance
| Generic name | Broncho-Vaxom |
|---|---|
| Also known as | OM-85, OM-85 BV VEGETAL, OM-85BV, OM85, Broncho-Vaxom concentrate (Bacterial lysate) |
| Sponsor | OM Pharma SA |
| Drug class | Bacterial lysate immunostimulant |
| Modality | Small molecule |
| Therapeutic area | Immunology / Respiratory |
| Phase | Phase 3 |
Mechanism of action
The drug contains a lyophilized bacterial lysate derived from eight common respiratory pathogens (Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella ozaenae, Staphylococcus aureus, Streptococcus pyogenes, Diplococcus pneumoniae, and Moraxella catarrhalis). It stimulates mucosal and systemic immunity by activating pattern recognition receptors and promoting the production of secretory IgA and other immune mediators, thereby reducing the frequency and severity of respiratory infections.
Approved indications
- Recurrent respiratory tract infections (sinusitis, otitis media, bronchitis, pneumonia)
- Chronic obstructive pulmonary disease (COPD) with recurrent exacerbations
Common side effects
- Gastrointestinal disturbances (nausea, diarrhea, abdominal discomfort)
- Headache
- Fever or malaise
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:
- Broncho-Vaxom CI brief — competitive landscape report
- Broncho-Vaxom updates RSS · CI watch RSS
- OM Pharma SA portfolio CI