Product Description
Istradefylline is used along with the combination of levodopa and carbidopa (Duopa, Rytary, Sinemet, others) to treat "off" episodes (times of difficulty moving, walking, and speaking that may happen as medication wears off or at random) in people with Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance). Istradefylline is in a class of medications called adenosine receptor antagonists. It works by changing the activity of certain natural substances in the brain. (Sourced from: https://medlineplus.gov/druginfo/meds/a619053.html)
Mechanisms of Action: ADORA2A Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Bangladesh | European Medicines Agency | Japan | United States
Approved Indications: None
Known Adverse Events: None
Company: Kyowa Hakko Kirin
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: United States
Active Clinical Trial Count: 1
Recent & Upcoming Milestones
- FDA accepted NDA for istradefylline, a potential Parkinson's disease treatment, by Kyowa Hakko Kirin. PDUFA action date is August 27, 2019.
Highest Development Phases
Phase 2: Cognitive Dysfunction|Parkinson's Disease
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT05333549 |
HM20022119 | P2 |
Completed |
Parkinson's Disease|Cognitive Dysfunction |
2025-06-09 |
12% |
2025-07-29 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
08/15/2024 |
News Article |
Vimgreen Completes Enrollment of Its Phase 2 Clinical Trial Evaluating VG081821AC for the Treatment of Parkinson's Disease |
|
12/06/2023 |
News Article |
Parkinson's Disease Therapeutics Market revenue to hit USD 12.32 Billion by 2033, Says We Market Research |
|
09/26/2023 |
News Article |
Parkinson's Disease Pipeline, Clinical Trials Assessment, and FDA Approvals 2023 |
|
05/12/2023 |
News Article |
Kyowa Kirin Presents New Findings from Real-World Study in Parkinson's Disease at the 2023 IAPRD Conference |