NDAORALTABLET
Approved
Aug 2019
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
16
Data completeness
4/8 — Partial
Drug data last refreshed 11h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NOURIANZ (istradefylline) is an oral small-molecule adenosine A2A receptor antagonist approved by the FDA in August 2019 for use as an adjunct to levodopa/carbidopa in patients with Parkinson's disease experiencing motor fluctuations. The drug works by blocking adenosine A2A receptors in the basal ganglia, reducing OFF time and improving motor control in advanced Parkinson's disease patients.
$50MPart D
LOE ApproachingStable
1.4 years to LOEWith ~$50M in annual Part D spending and approaching loss of exclusivity in 2028, the brand team is likely in defense mode, focusing on patient retention and managed care strategies rather than expansion.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (16)
Istradefylline Effect Protocol on Parkinson's Disease Tremor
Started Jan 2023
27 enrolled
Parkinson DiseaseTremor
Effect of Istradefylline Treatment on Behavioral Measures of Apathy in Parkinson's Disease.
Started Jul 2022
8 enrolled
ApathyParkinson Disease
Istradefylline for Parkinson Disease With Cognitive Impairment
Started Jul 2022
15 enrolled
Parkinson DiseaseCognitive Impairment
A Study to Evaluate Abuse Potential of Istradefylline
Started Jan 2016
42 enrolled
Drug Abuse
Long Term Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease
Started Dec 2015
239 enrolled
Idiopathic Parkinson's Disease
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.