Last reviewed · How we verify
OM-85-IN
OM-85-IN is a Small molecule drug developed by OM Pharma SA. It is currently in Phase 1 development.
-
Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | OM-85-IN |
|---|---|
| Sponsor | OM Pharma SA |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
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)
- 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)
- A Clinical Study Investigating OM-85-IN Safety and Tolerability in Healthy Volunteers and Mild Allergic Asthma Patients (PHASE1)
- 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-IN CI brief — competitive landscape report
- OM-85-IN updates RSS · CI watch RSS
- OM Pharma SA portfolio CI
Frequently asked questions about OM-85-IN
What is OM-85-IN?
Who makes OM-85-IN?
What development phase is OM-85-IN in?
Related
- Manufacturer: OM Pharma SA — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing