NDAORALTABLET
Approved
Aug 2019
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
16
Data completeness
4/8 — Partial
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NOURIANZ (istradefylline) is an oral tablet approved by the FDA in August 2019 for Parkinson's Disease and related movement disorders including apathy, tremor, and cognitive impairment. The mechanism of action and pharmacologic class are not specified in available data. It represents a non-biologic new drug application (NDA) addressing unmet needs in motor and non-motor symptoms of Parkinson's Disease.
$0.0BPart D
1.7 years to LOEMechanism 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.