NDAORALCAPSULE
Approved
Apr 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
17
Data completeness
5/8 — Partial
ONGENTYS (opicapone) by Amneal Pharms is catechol o-methyltransferase inhibitors [moa]. First approved in 2020.
Drug data last refreshed 13h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ONGENTYS (opicapone) is an oral catechol-O-methyltransferase (COMT) inhibitor approved in 2020 for use as an adjunctive therapy in Parkinson's disease. It works by inhibiting the enzyme responsible for breaking down levodopa, thereby extending the duration of levodopa's therapeutic effect and reducing motor fluctuations in patients experiencing wearing-off symptoms.
$16MPart D
Peak6.2 years to LOEProduct is at peak lifecycle stage with $16M in Part D spending (2023), indicating stable commercial momentum but modest market penetration suggesting mid-sized team structure.
Mechanism of Action
Catechol O-Methyltransferase Inhibitors
Pharmacologic Class:
Catechol-O-Methyltransferase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (17)
eArly levoDopa With Opicapone in Parkinson's paTients wIth motOr fluctuatioNs.
Started Nov 2021
106 enrolled
Parkinson Disease
OpicApone Sleep dISorder
Started Jun 2021
22 enrolled
Parkinson Disease
Early ParkinSon wIth L-DOPA/DDCI and OpicapoNe (EPSILON Study)
Started May 2021
410 enrolled
Parkinson
Opicapone Treatment Initiation Open-Label Study
Started Mar 2021
239 enrolled
Parkinson Disease
OpiCapone Effect on Motor Fluctuations and pAiN
Started Feb 2021
144 enrolled
Parkinson 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.