Ciclesonide
As of the edition of 20 October 2026, Ciclesonide is a small molecule: marketed, first approved in 2006 (CA); acts on NR3C1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Small molecule
- Brand name
- Omnaris
- First approved
- 11 September 2006 (CA)
- Approvals on record
- 11 in 6 regions
- Holder of the most recent approval
- Azurity Pharmaceuticals; 5 holders in all
- Registered trials
- 52, 6 stopped early
- Disease areas
- Lungs and airways; Immune system; Ear, nose and throat; Infections; Inherited and neonatal
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Ciclesonide.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| NR3C1 | Glucocorticoid receptor | P04150 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 3 | 0 | 0 |
| Phase 1 | 3 | 2 | 1 | 0 |
| Phase 2 | 8 | 2 | 0 | 5 |
| Phase 3 | 33 | 31 | 0 | 0 |
| Phase 4 | 4 | 3 | 0 | 1 |
| All trials | 52 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Takeda | Earlier holder | 2006 to now |
| Teijin Pharma | Applicant | 2011 to now |
| Azurity Pharmaceuticals | Acquired holder | 2026 to now |