COMTAN (entacapone)
Comtan (entacapone) is a catechol-O-methyltransferase (COMT) inhibitor indicated as an adjunct to levodopa and carbidopa for the treatment of patients with Parkinson’s disease who experience end-of-dose "wearing-off" symptoms. Its effectiveness has not been systematically evaluated in patients who do not experience these motor fluctuations. By stabilizing plasma levodopa levels, entacapone helps provide more consistent management of Parkinsonian signs and symptoms.
How COMTAN Works
Entacapone is a selective and reversible inhibitor of catechol-O-methyltransferase (COMT). When levodopa is administered with a decarboxylase inhibitor like carbidopa, COMT becomes the primary enzyme responsible for the peripheral metabolism of levodopa into 3-methoxy-4-hydroxy-L-phenylalanine (3-OMD). Entacapone acts primarily in the peripheral tissues to inhibit this process. This results in higher and more sustained plasma levels of levodopa, increasing the amount of levodopa available to cross the blood-brain barrier. Consequently, it leads to more constant dopaminergic stimulation in the central nervous system and enhances the therapeutic duration of levodopa.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1999-10-19
- Routes
- ORAL
- Dosage Forms
- TABLET
COMTAN Approval History
What COMTAN Treats
1 indicationsCOMTAN is approved for 1 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Parkinson's Disease
COMTAN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02096601 | ND0612/004 | Ph 1 | completed | A Safety, Tolerability, and Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Disease Patients |
| NCT02170376 results posted | BIA-91067-124 | Ph 1 | completed | The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics |
| NCT01568073 results posted | BIA-91067-301 2010-021860-13 | Ph 3 | completed | Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With "Wearing-off" Phenomenon |
| NCT01519284 results posted | BIA-91067-114 | Ph 1 | completed | Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetic |
| NCT01840423 NOCIFIM | 3112001 | Ph 1 | completed | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ODM-104 in Healthy Volunteers |
| NCT01688089 NOCOS | 3109001 | Ph 1 | completed | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ODM-103 in Healthy Volunteers |
| NCT00906828 DuoCOMT | DuoCOMT | Ph 4 | completed | Pharmacokinetics of Levodopa/Carbidopa Infusion With and Without Oral Catechol-O-methyl Transferase (COMT) Inhibitors |
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.
COMTAN FDA Label Details
Indications & Usage
FDA Label (PDF)COMTAN is indicated for the treatment of Parkinson's Disease.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment