Deflazacort
As of the edition of 20 October 2026, Deflazacort is a small molecule: marketed, first approved in 1990 (ES); acts on NR3C1; US protection ended in 2026.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2017
- Kind
- Small molecule
- Brand name
- Emflaza
- First approved
- 1 March 1990 (ES)
- Approvals on record
- 6 in 2 regions
- Holder of the most recent approval
- PTC Therapeutics; 2 holders in all
- Registered trials
- 15, 2 stopped early
- Disease areas
- Nervous system; Bones, joints and muscles; Inherited and neonatal; Ear, nose and throat; Immune system; Infections
US protection
US protection ended in 2026.
The last listed US exclusivity ended in 2026. The application that gives this date is held by PTC Therapeutics.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
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Target
| Gene | Protein | UniProt |
|---|---|---|
| NR3C1 | Glucocorticoid receptor | P04150 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 0 | 0 |
| Phase 1 | 8 | 7 | 0 | 0 |
| Phase 3 | 4 | 1 | 1 | 2 |
| Phase 4 | 2 | 1 | 0 | 0 |
| All trials | 15 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| PTC Therapeutics | Acquired holder and Lead sponsor of trials | 2017 to now |
| Marathon Pharmaceuticals | Originator | 2017 to 2017 |