Dexamethasone
As of the edition of 20 October 2026, Dexamethasone is a small molecule: marketed, first approved in 1959 (ES); 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 2013
- Kind
- Small molecule
- Brand name
- Decadron
- First approved
- 1 July 1959 (ES)
- Approvals on record
- 57 in 8 regions
- Holder of the most recent approval
- AbbVie; 18 holders in all
- Registered trials
- 2,431, 391 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Heart and blood vessels; Nervous system; Eye
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.
Ocular Therapeutix holds a later exclusivity on its own new formulation or combination product, ending 2028; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
5 companies on route B because of this drug.
Companies on route B for this drug
In the product5 companies are on route B because of Dexamethasone.
See the 5 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 | 280 | 150 | 51 | 20 |
| Phase 1 | 295 | 156 | 55 | 67 |
| Phase 2 | 1,020 | 462 | 256 | 189 |
| Phase 3 | 503 | 251 | 120 | 62 |
| Phase 4 | 333 | 165 | 53 | 53 |
| All trials | 2,431 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Applicant and Lead sponsor of trials | 1963 to now |
| Cheplapharm Arzneimittel | Later holder | 2000 to now |
| Bristol Myers Squibb | Applicant and Lead sponsor of trials | 2003 to now |
| Merck & Co. | Applicant and Lead sponsor of trials | 2004 to now |
| AbbVie | Applicant, Later holder and Lead sponsor of trials | 2004 to now |
| UCB | Acquired holder | 2006 to now |
| Alcon | Later holder and Lead sponsor of trials | 2006 to now |
| EyePoint Pharmaceuticals | Later holder and Lead sponsor of trials | 2014 to now |
| Ocular Therapeutix | Later holder and Lead sponsor of trials | 2014 to now |
| Theravia | Later holder | 2016 to now |
| Aspen | Acquired holder | 2018 to now |
| Dexcel Pharma Technologies | Later holder | 2019 to now |
| Santen Pharmaceutical | Applicant | 2021 to now |
| Harrow Eye | Acquired holder | 2023 to now |
| Organon | Later holder |