Drug intelligence / Profile preview

OM-85

Development stage
Phase 4
Lead developer
OM Pharma
Modality
Split/Subunit Vaccines → Inactivated Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics, Whole Cell Cancer Vaccines → Cancer Vaccines → Therapeutic Vaccines → Vaccines & Immunotherapeutics
Administration
Oral
01

Overview

OM-85 is an oral immunostimulant composed of a standardized mixture of bacterial lysates derived from 21 strains across 8 species of common respiratory tract pathogens. It is primarily used to prevent recurrent respiratory tract infections (RTIs) and reduce exacerbations in chronic lung diseases such as asthma and COPD. The active components are obtained by alkaline or chemical lysis of bacteria including Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae, Klebsiella ozaenae, Staphylococcus aureus, Streptococcus pyogenes (including viridans group), and Moraxella catarrhalis. Mechanistically, OM-85 acts by stimulating both innate and adaptive immunity via the gut-lung axis. It promotes maturation of dendritic cells in Peyer’s patches leading to enhanced mucosal immune defense in the lungs. This results in upregulation of antiviral cytokines like interferon-gamma (IFN-γ), downregulation of Th2 cytokines (IL-4, IL-5, IL-13), reduction in IgE levels among allergic individuals, increased anti-inflammatory cytokine production (such as IL-10), and overall rebalancing toward a less inflammatory state[1][2][3][7][8]. OM-85 has been shown to reduce the frequency and severity of RTIs in children and adults with favorable safety comparable to placebo[1][3]. It may also have potential benefits for preventing COVID‑19 infection or complications[7], as well as reducing wheezing episodes/asthma development risk in children[4].

Brand names
Broncho-Vaxom
Other names
oral bacterial lysatebacterial extract OM-85-BV
02

Targets

NLRP6 inflammasomeTLR (Toll-like receptors)

Beyond the preview

Go deeper on OM-85.

Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.

Clinical trials

Full profile access

Follow clinical development from study design and recruitment through results.

  • Trial phase
  • Status
  • Readouts

Indications & development

Full profile access

Explore development by indication, patient population, and geography.

  • Indications
  • Development status
  • Countries

Licensing & deals

Full profile access

Trace asset ownership, licensing agreements, and commercial partnerships.

  • Partners
  • Deal terms
  • Milestones

Patents & exclusivity

Full profile access

Explore the patent landscape and regulatory exclusivity around an asset.

  • Patents
  • Expiration dates
  • Exclusivity

Competitive landscape

Full profile access

Compare development programs by target, modality, and indication.

  • Competing assets
  • Targets
  • Development stage

Research & analysis

Full profile access

Connect source evidence and development news to your research questions.

  • Publications
  • News
  • Analysis

Bring the full picture into focus.

See how Gosset can support your research on OM-85.

Explore the full profile

Gosset Free

Get started with Gosset.

Enter your work email and we’ll be in touch with next steps.

Work email preferred.

Book a call