Wednesday, July 8, 2026

Drug profile · INN

entacapone

entacapone (COMTAN) is a catechol o-methyltransferase inhibitor. Associated with Sandoz Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Nervous system (N04) N04BX02
US status approved
Patents linked 0
Pipeline programs 2
News articles 0
Drug details — entacapone
US status
approved
Class
Nervous system (N04)
Route
ORAL
Patents
0
Programs
2
Data quality
0.89

Quick answer

entacapone (COMTAN) is a catechol o-methyltransferase inhibitor. Associated with Sandoz Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN entacapone
Brand COMTAN
Mechanism Catechol O-methyltransferase inhibitor
Target Catechol O-methyltransferase
Therapeutic class Nervous system (N04)
Route ORAL
Formulation TABLET
ATC code N04BX02
Originator Sandoz Pty Ltd

Mechanism of action

Catechol O-methyltransferase inhibitor

Primary target: Catechol O-methyltransferase

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. L-dopa / carbidopa / entacapone (LCE) Phase 1 · BRIGHT MINDS BIOSCIENCES · Cocaine Abuse
  2. CELC200A2406 Approved · Novartis India · Parkinson's Disease

Related & competitor drugs

  1. aripiprazole Nervous system (N05)
  2. brexpiprazole Nervous system (N05)
  3. brivaracetam Nervous system (N03)
  4. bupivacaine Nervous system (N01)
  5. buprenorphine Nervous system (N07)
  6. caffeine citrate Nervous system (N06)

Frequently asked questions

What is entacapone?

entacapone (COMTAN) is a catechol o-methyltransferase inhibitor. Associated with Sandoz Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for entacapone?

COMTAN is a marketed brand name for entacapone. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of entacapone?

entacapone has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.