Istradefylline
As of the edition of 20 October 2026, Istradefylline is a small molecule: marketed, first approved in 2013 (JP); acts on ADORA2A.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Small molecule
- Brand name
- Nourianz
- First approved
- 25 March 2013 (JP)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Kyowa Kirin; 2 holders in all
- Registered trials
- 27, 2 stopped early
- Disease areas
- Nervous system; Mental health; Chemically induced; Injuries; Lungs and airways
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
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Istradefylline.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| ADORA2A | Adenosine receptor A2a | P29274 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 0 | 1 |
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 11 | 8 | 3 | 0 |
| Phase 3 | 11 | 10 | 0 | 1 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 27 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Kyowa Kirin | Applicant and Lead sponsor of trials | 2002 to now |