FDA · United States
desonide — FDA regulatory status
desonide (DESOWEN) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- DESOWEN
- Mechanism
- Glucocorticoid receptor agonist
- Target
- Glucocorticoid receptor
- Structured fields
- 7
Pharmacology context used for competitive intelligence: Glucocorticoid receptor agonist. Target: Glucocorticoid receptor. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 33 published clinical programs and 5 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| Budesonide | Phase 3 | Bausch + Lomb | NCT01100112 |
| Budesonide | Phase 3 | AstraZeneca | NCT00855959 |
| Budesonide and formoterol fumarate dehydrate (BF) SPIROMAX | Phase 3 | Teva Pharma | NCT02062463 |
| Budesonide oral suspension | Phase 3 | Takeda | NCT03245840 |
| Budesonide/Formoterol SPIROMAX® | Phase 3 | Teva Pharma | NCT01803555 |
| Budesonide/Formoterol fumarate dihydrate | Phase 3 | Teva Pharma | NCT05831566 |
| Budesonide/formoterol Turbuhaler | Phase 3 | AstraZeneca | NCT00242775 |
| C0251010 | Phase 3 | First Biotech (Australia) | 2024-514648-10-00 |
| D5982C00007 | Phase 3 | AstraZeneca | 2023-505787-11-00 |
| D5982C00008 | Phase 3 | AstraZeneca | 2023-505786-88-00 |
| EFC14771 | Phase 3 | Sanofi-Aventis U.S | 2023-504331-41-00 |
| Generic Budesonide/Formoterol Fumarate Dihydrate | Phase 3 | Teva Pharma | NCT02495168 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 11413296 | Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract | US |
| 9119863 | Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract | US |
| 8975243 | Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract | US |
| 8497258 | Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract | US |
| 8324192 | Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract | US |
Related hubs
FAQ
What is the FDA approval status of desonide?
desonide currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get desonide regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to desonide?
This spoke lists 33 published programs associated with desonide in our pipeline index.