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Drug

Entacapone

Approved · EMA
Late-stage development
Also known as Comtan, Stalevo, Entacapona, (E)-alpha-Cyano-N,N-diethyl-3,4-dihydroxy-5-nitrocinnamamide+3 more

Comtan, Stalevo, Entacapona, (E)-alpha-Cyano-N,N-diethyl-3,4-dihydroxy-5-nitrocinnamamide, Carbidopa/Entacapone/Levodopa, Entacaponum, N,N-diethyl-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl) acrylamide.

RxNorm60307ChEMBLCHEMBL953UNII4975G9NM6T
1
Active clinical trials
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase IIa Multicenter, Randomized, Double-blind, Placebo-controlled Study Followed by an Open-label Period, to Evaluate the Safety, Tolerability, and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations, Administered With Repeated Subcutaneous ND0612

Clinical trial2026-07-09Results posted · ClinicalTrials.gov

Treatment of Orthostatic Intolerance

Clinical trial2025-10-08Results expected Q4 2029 · ClinicalTrials.gov

Entacapone in Combination With Imatinib Mesylate for Treatment of Patients With Gastrointestinal Stromal Tumors(GIST) Following Failure of at Least Imatinib and Sunitinib

Clinical trial2022-08-31Completed · ClinicalTrials.gov

Pilot Study of the Dose Response of Entacapone on Methamphetamine Induced Interest, Mood Elevation, and Reward

Clinical trial2019-09-12Results posted · ClinicalTrials.gov

The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics When Administered With Immediate-release 100/25 mg Levodopa/Carbidopa in Healthy Subjects

Clinical trial2016-09-20Results posted · ClinicalTrials.gov

Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With "Wearing-off" Phenomenon Treated With Levodopa Plus a Dopa Decarboxylase Inhibitor (DDCI): a Double-blind, Randomised, Placebo- and Active-controlled, Parallel-group, Multicentre Clinical Study

Clinical trial2015-09-18Results posted · ClinicalTrials.gov

Effect of Entacapone on Bodyweight Loss in Obese Population: A Randomized, Double-blind, Placebo-controlled, Pilot Trial

Clinical trial2015-09-01Primary completion · ClinicalTrials.gov

A Double-blind, Randomised, Placebo- and Active-controlled Multiple-dose Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetics Following a Levodopa/Carbidopa 100/25 mg Single-dose in Healthy Subjects

Clinical trial2015-08-20Results posted · ClinicalTrials.gov

A Multicenter, Open-Label, Randomized, Dose-Finding Study Testing the Safety, Tolerability, and Pharmacokinetics (PK) of ND0612, a Liquid Formulation of Levodopa/Carbidopa (LD/CD) Delivered as a Continuous Subcutaneous Infusion (SC) in Parkinson's Disease (PD) Patients Treated With LD

Clinical trial2015-03-15Completed · ClinicalTrials.gov

Approval: Entacapone Orion (EMA)

Regulatory2011-08-18EMA

Approval: Comtan (EMA)

Regulatory1998-09-22EMA

Approval: Comtess (EMA)

Regulatory1998-09-16EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Entacapone
Aliases & brands
ComtanStalevoEntacapona(E)-alpha-Cyano-N,N-diethyl-3,4-dihydroxy-5-nitrocinnamamideCarbidopa/Entacapone/LevodopaEntacaponumN,N-diethyl-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl) acrylamide
RxNorm CUI
60307
ChEMBL ID
CHEMBL953
UNII
4975G9NM6T
Regulatory jurisdictions
ema

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
1998-09-16
Latest approval
2011-08-18
Authorities
EMA
Total events
3
emaEuropean Medicines Agency· 3 events
2011-08-18Approval
Approval: Entacapone Orion (EMA)
Indication: Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose… Show full indication

Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.

Evidence ↗
1998-09-22Approval
Approval: Comtan (EMA)
Indication: Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose… Show full indication

Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.

Evidence ↗
1998-09-16Approval
Approval: Comtess (EMA)
Indication: Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in patients with Parkinson's disease and end-of-dose motor… Show full indication

Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

16 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
16
registered trials across all phases
LATEST COMPLETION 2022
1
Active studies
4
Late-stage (III+)
13
Completed
2
Discontinued
PHASE DISTRIBUTIONn = 16
Early Phase 12Phase 15Phase 1 / 23Phase 22Phase 31Phase 42Phase N / A1

Recent completions

Trials that read out recently, adding to the completed evidence base.

Entacapone in Combination With Imatinib Mesylate for Treatment of Patients With Gastrointestinal Stromal Tumors(GIST) Following Failure of at Least Imatinib and Sunitinib

CompletedPH IXiangya Hospital of Central South Universityn=52022

Pilot Study of the Dose Response of Entacapone on Methamphetamine Induced Interest, Mood Elevation, and Reward

CompletedPH IOregon Health and Science Universityn=292016

A Phase IIa Multicenter, Randomized, Double-blind, Placebo-controlled Study Followed by an Open-label Period, to Evaluate the Safety, Tolerability, and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations, Administered With Repeated Subcutaneous ND0612

CompletedPH IINeuroDerm Ltd.n=302015

A Multicenter, Open-Label, Randomized, Dose-Finding Study Testing the Safety, Tolerability, and Pharmacokinetics (PK) of ND0612, a Liquid Formulation of Levodopa/Carbidopa (LD/CD) Delivered as a Continuous Subcutaneous Infusion (SC) in Parkinson's Disease (PD) Patients Treated With LD

CompletedPH INeuroDerm Ltd.n=162015

Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Single and Repeated Escalating Doses of ODM-104: a Randomised, Double-blind, Placebo- and Entacapone-controlled Single Centre First-in-man Study in Healthy Volunteers.

CompletedPH IOrion Corporation, Orion Pharman=1012014

Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Single and Repeated Escalating Doses of ODM-103: a Randomised, Double-blind, Placebo- and Entacapone-controlled Single Centre First-in-man Study in Healthy Volunteers.

CompletedPH IOrion Corporation, Orion Pharman=672014
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.