EMA · European Union
budesonide — EMA regulatory status
budesonide (BUDENOFALK) regulatory status in the European Union is tracked from public EMA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: EMA approved.
Status snapshot
- Status
- EMA approved
- Brand
- BUDENOFALK
- Originator
- AstraZeneca
- Mechanism
- Glucocorticoid receptor agonist
- Target
- Glucocorticoid receptor
- Structured fields
- 8
Sponsor / originator context: AstraZeneca. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
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 — EMA: approved.
Linked evidence on this spoke: 41 published clinical programs and 12 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 |
|---|---|---|---|---|
| EMA | European Union | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| BUL-8/EEA | Phase 3 | Dr. Falk Pharma | 2024-515229-26-00 |
| 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 |
| CO45042 | Phase 3 | HOFFMANN-LA ROCHE | 2024-518365-10-00 |
| D3250C00101 | Phase 3 | AstraZeneca | 2024-515162-13-00 |
| D5982C00006 | Phase 3 | AstraZeneca | 2024-513568-24-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12123012 | Methods and compositions for nucleic acid and protein payload delivery | US |
| 11970482 | Acetal compounds and therapeutic uses thereof | US |
| 11773110 | Heterocycle amines and uses thereof | US |
| 11566041 | Nucleotide prodrug compounds | US |
| 11413296 | Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract | US |
| 11278559 | Prodrug compounds and their uses | US |
| 11197822 | Topical corticosteroids for the treatment of inflammatory diseases of the gastrointestinal tract | US |
| 11186593 | Heterocycle amines and uses thereof | US |
| 10975388 | Methods and compositions for nucleic acid and protein payload delivery | US |
| 10874638 | Methods and compositions for modulating hormone levels | US |
| 10604533 | Heterocycle amines and uses thereof | US |
| 10449210 | Prodrug compounds and their uses | US |
Related hubs
FAQ
What is the EMA approval status of budesonide?
budesonide currently shows EMA approved in our European Union regulatory index. Confirm on the official EMA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get budesonide 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 budesonide?
This spoke lists 41 published programs associated with budesonide in our pipeline index.