ENTACAPONE
Entacapone is a catechol-O-methyltransferase (COMT) inhibitor indicated for use as an adjunct to levodopa and carbidopa therapy. It is specifically used to treat patients with Parkinson’s disease who experience end-of-dose "wearing-off" symptoms. The drug's therapeutic role is to enhance the effects of levodopa by maintaining more consistent levels of the medication in the body. Its effectiveness has not been established in Parkinson's patients who do not experience these "wearing-off" periods.
How ENTACAPONE Works
Entacapone works by selectively and reversibly inhibiting the enzyme catechol-O-methyltransferase (COMT), which is a major metabolizing enzyme for levodopa. When administered alongside levodopa and a decarboxylase inhibitor like carbidopa, entacapone prevents the peripheral breakdown of levodopa. This results in higher and more sustained plasma levels of levodopa, allowing for more constant dopaminergic stimulation in the brain. This process helps to manage the signs and symptoms of Parkinson’s disease more effectively than levodopa and carbidopa alone.
Details
- Status
- Prescription
- First Approved
- 2012-07-16
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
ENTACAPONE Approval History
What ENTACAPONE Treats
1 indicationsENTACAPONE is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- End-of-dose "wearing-off" in patients with Parkinson's disease
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ENTACAPONE FDA Label Details
ProIndications & Usage
Entacapone tablets USP are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose "wearing-off" in patients with Parkinson's disease (see CLINICAL PHARMACOLOGY, Clinical Studies ). Entacapone's effectiveness has not been systematically evaluated in patients with Parkinson's disease who do not experience end-of-dose "wearing-off".
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.