Fluticasone propionate
As of the edition of 20 October 2026, Fluticasone propionate is a small molecule: marketed, first approved in 1990 (US); acts on NR3C1; no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Small molecule
- Brand name
- Cutivate
- First approved
- 14 December 1990 (US)
- Approvals on record
- 56 in 5 regions
- Holder of the most recent approval
- Teva; 10 holders in all
- Withdrawn from market
- 23 May 2025 (in some regions)
- Registered trials
- 190, 15 stopped early
- Disease areas
- Lungs and airways; Immune system; Ear, nose and throat; Blood and lymph; Digestive system; Infections
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Transcept Pharmaceuticals holds a later exclusivity on its own new formulation or combination product, ending 2027; it does not protect the original 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 propionate.
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 | 23 | 19 | 1 | 2 |
| Phase 1 | 22 | 21 | 0 | 1 |
| Phase 2 | 30 | 26 | 2 | 2 |
| Phase 3 | 61 | 52 | 2 | 3 |
| Phase 4 | 54 | 42 | 4 | 7 |
| All trials | 190 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Acquired holder, Later holder, Earlier holder and Lead sponsor of trials | 1990 to now |
| Fougera Pharmaceuticals | Acquired holder and Lead sponsor of trials | 2007 to now |
| Teva | Applicant, Later holder and Lead sponsor of trials | 2012 to now |
| Kyorin Pharmaceutical | Applicant | 2020 to now |
| Haleon | Acquired holder and Lead sponsor of trials | 2024 to now |
| Transcept Pharmaceuticals | Acquired holder | 2025 to now |