Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OP0201 · 2 trials · 1 indication
Percentage of study participants with no bulging tympanic membrane
| Arm | Type | Description |
|---|---|---|
| Drug: OP0201 + Antibiotics | ACTIVE_COMPARATOR | OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days |
| Placebo Comparator: Placebo +Antibiotics | PLACEBO_COMPARATOR | Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days |
| Drug: OP0201 | ACTIVE_COMPARATOR | - |
| Drug: Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| OP0201 | COMBINATION_PRODUCT | OP0201 20mg per day in two divided doses for 10 days |
| Placebo | COMBINATION_PRODUCT | Placebo 0mg per day in two divided doses for 10 days |
| Amoxicillin-clavulanate | DRUG | Oral Amoxicillin-clavulanate in two divided doses for 10 days |
| Drug: OP0201 20mg | COMBINATION_PRODUCT | OP0201 |
| Drug: Placebo 0mg | COMBINATION_PRODUCT | Placebo |
Inclusion Criteria includes but is not limited to: 1. Male and female infants and children aged ≥6 months to ≤24 months 2. Diagnosis of Acute Otitis Media (AOM) - moderate to severe bulging of the TM or mild bulging of TM and recent \[less than 48 hours\] onset of ear pain or intense erythema of th...
OP0201 is an investigational small molecule being developed by Eledon Pharmaceuticals, Inc. for the treatment of acute otitis media, a middle ear infection. It is designed as an adjunct treatment, meaning it is studied alongside standard therapy rather than as a replacement. OP0201 has completed Phase 2 clinical testing and is not approved for commercial use.
OP0201 is being studied as an adjunct treatment for acute otitis media in infants, children, and adults. The Phase 2 trial enrolled infants and children aged 6 to 24 months, while an earlier Phase 1 trial enrolled adults aged 18 years and older. Both trials evaluated safety, tolerability, and efficacy, including reduction of ear pain.
OP0201 is developed by Eledon Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker symbol ELDN. The company sponsors the clinical program for the drug in acute otitis media.
OP0201 has completed Phase 2 clinical development. Two trials have been completed: a Phase 2 study in infants and children and a Phase 1 study in adults. No trials are currently active, and OP0201 is an investigational drug that has not been approved by the FDA.
OP0201 has been evaluated in two completed trials. NCT03818815 was a Phase 2 study of OP0201 as an adjunct treatment for acute otitis media in infants and children aged 6 to 24 months, enrolling 103 participants in the United States. NCT03766373 was a Phase 1 study in 24 adults with acute otitis media.