Entacapone - PharmaKB

Comtan, Comtess(entacapone)

/ Entacapone /, Comtan, Comtess, Corbilta, Entacapone, Levodopa/Carbidopa/Entacapone, Stalevo (entacapone) is a small molecule pharmaceutical. Entacapone was first approved as Comtess on 1998-09-16. It is used to treat parkinson disease in the USA. It has been approved in Europe to treat parkinson disease. The pharmaceutical is active against catechol O-methyltransferase.

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SARS-CoV-2 Interaction

Novartis Pharmaceuticals

Events Timeline

Commercial

Clinical

Drug

Target

Variants

Financial

Trends

Safety

Events Timeline

YTD

Max

Events

FDA approval date

EMA approval date

Patent expiration date

Study first post date

Last update post date

Start date

Primary completion date

Completion date

Results first post date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
nervous system diseases	D009422

Trade Name

FDA

EMA

Comtan, Entacapone (discontinued: Entacapone)

Combinations

Carbidopa, levodopa entacapone, Stalevo (discontinued: Carbidopa, levodopa entacapone)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Entacapone

Tradename	Company	Number	Date	Products
COMTAN	Orion Pharma	N-020796 RX	1999-10-19	1 products, RLD, RS

Carbidopa

Entacapone

Levodopa

Tradename	Company	Number	Date	Products
STALEVO 50	Orion Pharma	N-021485 RX	2003-06-11	1 products, RLD, RS
STALEVO 100	Orion Pharma	N-021485 RX	2003-06-11	1 products, RLD
STALEVO 150	Orion Pharma	N-021485 RX	2003-06-11	1 products, RLD
STALEVO 200	Orion Pharma	N-021485 RX	2007-08-02	1 products, RLD, RS
STALEVO 75	Orion Pharma	N-021485 RX	2008-08-29	1 products, RLD
STALEVO 125	Orion Pharma	N-021485 RX	2008-08-29	1 products, RLD

Labels

FDA

EMA

Brand Name	Status	Last Update
carbidopa, levodopa and entacapone	ANDA	2022-02-01
carbidopa, levodopa, and entacapone	NDA authorized generic	2016-02-01
comtan	New Drug Application	2021-07-30
entacapone	ANDA	2025-01-20
stalevo	New Drug Application	2021-07-30

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
parkinson disease	EFO_0002508	D010300	G20

Agency Specific

FDA

EMA

No data

Patent Expiration

No data

ATC Codes

N: Nervous system drugs

— N04: Anti-parkinson drugs

— N04B: Dopaminergic agents

— N04BX: Other dopaminergic agents in atc

— N04BX02: Entacapone

HCPCS

No data

Clinical

Clinical Trials

64 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Parkinson disease	D010300	EFO_0002508	G20	12	12	6	13	6	47
Treatment adherence and compliance	D000074822	—	—	—	—	—	1	—	1

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Cocaine-related disorders	D019970	—	F14	1	1	1	—	—	2

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Nervous system diseases	D009422	—	G00-G99	1	3	—	—	1	4
Shy-drager syndrome	D012791	EFO_1001050	—	2	1	—	—	1	3
Multiple system atrophy	D019578	—	—	2	1	—	—	1	3
Central nervous system diseases	D002493	—	G96.9	—	2	—	—	—	2
Brain diseases	D001927	—	G93.40	—	2	—	—	—	2
Movement disorders	D009069	EFO_0004280	G25	—	2	—	—	—	2
Neurodegenerative diseases	D019636	EFO_0005772	G31.9	—	2	—	—	—	2
Schizophrenia	D012559	EFO_0000692	F20	—	1	—	—	1	2
Obesity	D009765	EFO_0001073	E66.9	1	1	—	—	—	1
Body weight	D001835	EFO_0004338	—	1	1	—	—	—	1

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—	—	—	8	—	—	—	—	8
Pure autonomic failure	D054970	—	—	1	—	—	—	—	1
Lewy body disease	D020961	EFO_0006792	G31.83	1	—	—	—	—	1
Dementia	D003704	EFO_0003862	F03	1	—	—	—	—	1
Gastrointestinal stromal tumors	D046152	EFO_0000505	C49.A	1	—	—	—	—	1
Pharmacokinetics	D010599	—	—	1	—	—	—	—	1
Disease	D004194	EFO_0000408	R69	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Parkinsonian disorders	D020734	—	G20.C	—	—	—	—	1	1
Neurologic gait disorders	D020233	—	R26.1	—	—	—	—	1	1
Huntington disease	D006816	Orphanet_399	G10	—	—	—	—	1	1
Progressive supranuclear palsy	D013494	EFO_0002512	G23.1	—	—	—	—	1	1
Corticobasal degeneration	D000088282	—	G31.85	—	—	—	—	1	1
Narcolepsy	D009290	EFO_0000614	G47.4	—	—	—	—	1	1
Sleep wake disorders	D012893	—	G47	—	—	—	—	1	1
Parasomnias	D020447	—	G47.5	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Entacapone
INN	entacapone
Description	Entacapone is a monocarboxylic acid amide that is N,N-diethylprop-2-enamide in which the hydrogen at position 2 is substituted by a cyano group and the hydrogen at the 3E position is substituted by a 3,4-dihydroxy-5-nitrophenyl group. It has a role as an EC 2.1.1.6 (catechol O-methyltransferase) inhibitor, an antiparkinson drug, a central nervous system drug and an antidyskinesia agent. It is a monocarboxylic acid amide, a nitrile, a member of catechols and a member of 2-nitrophenols.
Classification	Small molecule
Drug class	catechol-O-methyltransferase (COMT) inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CCN(CC)C(=O)/C(C#N)=C/c1cc(O)c(O)c([N+](=O)[O-])c1

Identifiers

PDB	—
CAS-ID	130929-57-6
RxCUI	—
ChEMBL ID	CHEMBL953
ChEBI ID	4798
PubChem CID	5281081
DrugBank	DB00494
UNII ID	4975G9NM6T (ChemIDplus, GSRS)

Target

Agency Approved

No data

Alternate

FTO

Organism

Homo sapiens

Gene name

FTO

Gene synonyms

KIAA1752

NCBI Gene ID

79068

Protein name

alpha-ketoglutarate-dependent dioxygenase FTO

Protein synonyms

AlkB homolog 9, fat mass and obesity associated, Fat mass and obesity-associated protein, intragenic FTO exon 9 containing transcript, m6A(m)-demethylase FTO, mRNA (2'-O-methyladenosine-N(6)-)-demethylase FTO, mRNA N(6)-methyladenosine demethylase FTO, tRNA N1-methyl adenine demethylase FTO, U6 small nuclear RNA (2'-O-methyladenosine-N(6)-)-demethylase FTO, U6 small nuclear RNA N(6)-methyladenosine-demethylase FTO

Uniprot ID

Q9C0B1

Mouse ortholog

Fto (26383)

alpha-ketoglutarate-dependent dioxygenase FTO (Q9QZ13)

Variants

No data

Financial

Revenue by drug

€

₣

No data

Estimated US medical usage

Entacapone

Levodopa

Carbidopa

Total medical expenditures per year (USD, in millions)

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Number of persons purchased

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Number of purchases

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Refill frequency

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Price per prescription (USD)

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Entacapone

Total medical expenditures per year (USD, in millions)

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Number of persons purchased

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Number of purchases

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Refill frequency

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Price per prescription (USD)

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Trends

PubMed Central

Top Terms for Disease or Syndrome:

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Additional graphs summarizing 2,860 documents

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Safety

Black-box Warning

No Black-box warning

Adverse Events

Top Adverse Reactions

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5,602 adverse events reported

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