Fluticasone
As of the edition of 20 October 2026, Fluticasone is a small molecule: marketed, first approved in 1990 (US); acts on NR3C1; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2009
- Kind
- Small molecule
- Brand name
- Cutivate
- First approved
- 14 December 1990 (US)
- Approvals on record
- 80 in 5 regions
- Holder of the most recent approval
- GSK; 10 holders in all
- Registered trials
- 92, 12 stopped early
- Disease areas
- Lungs and airways; Immune system; Ear, nose and throat; Infections; Blood and lymph; Digestive system
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
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 Fluticasone.
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 | 27 | 20 | 1 | 4 |
| Phase 1 | 6 | 6 | 0 | 0 |
| Phase 2 | 10 | 5 | 2 | 2 |
| Phase 3 | 19 | 10 | 1 | 3 |
| Phase 4 | 30 | 20 | 1 | 3 |
| All trials | 92 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Acquired holder, Later holder, Earlier holder and Lead sponsor of trials | 1990 to now |
| Teva | Later holder | 2017 to now |
| Kyorin Pharmaceutical | Applicant | 2020 to now |
| Haleon | Acquired holder | 2024 to now |
| Transcept Pharmaceuticals | Acquired holder | 2025 to now |
| Fougera Pharmaceuticals | Acquired holder | 2026 to now |