Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OP0201 · 1 trial · 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 |
| 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 |
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 studied as an adjunct treatment for acute otitis media in infants and children aged 6 to 24 months. It is intended to be used alongside standard care for this ear infection. The drug is currently in Phase 2 clinical development and is not yet approved.
OP0201 is being developed by Eledon Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker ELDN. The company is conducting clinical research on this investigational drug for the treatment of acute otitis media in young children.
OP0201 is in Phase 2 clinical development. It has completed one Phase 2 trial, and the drug remains investigational, meaning it has not been approved by regulatory authorities. Further clinical studies would be needed to establish its safety and efficacy for acute otitis media.
OP0201 has been studied in one completed Phase 2 clinical trial, identified as NCT03818815. This randomized, double-blind, placebo-controlled study assessed the safety, tolerability, and efficacy of OP0201 as an adjunct treatment for acute otitis media in infants and children aged 6 to 24 months. The trial enrolled 103 participants in the United States.
The mechanism of action for OP0201 has not been disclosed in available information. It is classified as a small molecule, but its specific molecular target is not specified. The drug is being evaluated for its potential to improve outcomes when added to standard treatment for acute otitis media in young children.