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OM-85 BV
OM-85 BV is a bacterial lysate immunostimulant that enhances innate and adaptive immune responses to prevent respiratory tract infections.
OM-85 BV is an immunostimulant derived from bacterial lysates that enhances innate and adaptive immune responses to prevent respiratory tract infections. Used for Prevention of recurrent respiratory tract infections, Prophylaxis of acute exacerbations in chronic bronchitis and COPD.
At a glance
| Generic name | OM-85 BV |
|---|---|
| Also known as | Bronchovaxom, Bronchovaxom 3.5 mg placebo capsule |
| Sponsor | Chinese Academy of Medical Sciences |
| Drug class | Bacterial lysate immunostimulant |
| Modality | Small molecule |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
OM-85 BV is composed of lysates from 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 through pattern recognition receptors, promoting the production of immunoglobulins and enhancing phagocytic activity. This broad immune activation reduces the incidence and severity of recurrent respiratory infections.
Approved indications
- Prevention of recurrent respiratory tract infections
- Recurrent sinusitis
- Recurrent otitis media
- Recurrent bronchitis
Common side effects
- Gastrointestinal disturbances
- Mild fever
- Headache
- Allergic reactions
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 |