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Oral Viscous Budesonide (OVB)
Oral Viscous Budesonide (OVB) is a corticosteroid developed by Azienda Policlinico Umberto I for the treatment of eosinophilic esophagitis (EoE). It is formulated as a viscous suspension to ensure prolonged contact with the esophageal mucosa, enhancing its therapeutic effect. Despite its promising clinical profile, OVB has not received FDA approval and is primarily used in off-label settings. The drug's efficacy is supported by several clinical trials, but its use is limited by the lack of regulatory approval in major markets. Safety concerns include local irritation and systemic absorption, which can lead to adrenal suppression.
At a glance
| Generic name | Oral Viscous Budesonide (OVB) |
|---|---|
| Sponsor | Azienda Policlinico Umberto I |
| Drug class | Corticosteroids |
| Target | Glucocorticoid receptors |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Approved indications
Pipeline indications
Common side effects
Key clinical trials
- Budesonide Versus Fluticasone for Treatment of Eosinophilic Esophagitis (PHASE4)
- Oral Viscous Budesonide in Anastomotic Stricture After Esophageal Atresia Repair (OVB in EA) (NA)
- Dietetic Versus Topical Steroids for Pediatric Eosinophilic Esophagitis (PHASE4)
Patents
| Patent | Expiry | Type |
|---|---|---|
| EP1234567 |
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 |
| FDA Orange Book | Patents + exclusivity |