Comtan, Comtess(entacapone)
Comtan, Comtess, Corbilta, 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. In addition, it is known to target alpha-ketoglutarate-dependent dioxygenase FTO.
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Novartis Pharmaceuticals
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
---|---|
nervous system diseases | D009422 |
Trade Name
FDA
EMA
Comtan (generic drugs available since 2012-05-10)
CombinationsStalevo (generic drugs available since 2012-05-10)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Carbidopa
+
Entacapone
+
Levodopa
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
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 |
STALEVO 200 | Orion Pharma | N-021485 RX | 2007-08-02 | 1 products, RLD, RS |
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 |
Entacapone
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
COMTAN | Orion Pharma | N-020796 RX | 1999-10-19 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
comtan | New Drug Application | 2020-05-01 |
entacapone | ANDA | 2023-06-21 |
stalevo | New Drug Application | 2020-05-01 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
parkinson disease | EFO_0002508 | D010300 | G20 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
45 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 | 9 | 9 | 3 | 11 | 1 | 31 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Multiple system atrophy | D019578 | 2 | 1 | — | — | — | 2 | ||
Obesity | D009765 | EFO_0001073 | E66.9 | 1 | 1 | — | — | — | 1 |
Autonomic nervous system diseases | D001342 | EFO_0009532 | G90 | 1 | 1 | — | — | — | 1 |
Tachycardia | D013610 | HP_0001649 | R00.0 | 1 | 1 | — | — | — | 1 |
Orthostatic intolerance | D054971 | 1 | 1 | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Sleep wake disorders | D012893 | G47 | — | — | — | — | 1 | 1 | |
Schizophrenia | D012559 | EFO_0000692 | F20 | — | — | — | — | 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 |
Target
Agency Approved
Alternate
FTO
FTO
Organism
Homo sapiens
Gene name
FTO
Gene synonyms
KIAA1752
NCBI Gene ID
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
Mouse ortholog
Fto (26383)
alpha-ketoglutarate-dependent dioxygenase FTO (Q9QZ13)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,337 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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26,856 adverse events reported
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