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Ongentys(opicapone)
Ongentys, Ontilyv (opicapone) is a small molecule pharmaceutical. Opicapone was first approved as Ongentys on 2016-06-24. 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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FDA Novel Drug Approvals 2020
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
Trade Name
FDA
EMA
Ongentys
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Opicapone
Tradename
Company
Number
Date
Products
ONGENTYSNeurocrine BiosciencesN-212489 RX2020-04-24
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
ongentysNew Drug Application2020-04-24
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
parkinson diseaseEFO_0002508D010300G20
Agency Specific
FDA
EMA
Expiration
Code
OPICAPONE, ONGENTYS, NEUROCRINE
2025-04-24NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Opicapone, Ongentys, Neurocrine
103574682035-05-27U-2812
96309552032-12-12DS, DPU-2811
100710852030-03-31DP
105831302030-03-31U-2811
85247462029-07-14U-2811
81687932029-04-02DS, DPU-2811
97452902027-10-10DPU-2811
89070992027-05-12DP
95507592026-07-26U-2811, U-2817, U-2818
ATC Codes
N: Nervous system drugs
— N04: Anti-parkinson drugs
— N04B: Dopaminergic agents
— N04BX: Other dopaminergic agents in atc
— N04BX04: Opicapone
HCPCS
No data
Clinical
Clinical Trials
45 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Parkinson diseaseD010300EFO_0002508G2029235241
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
EpilepsyD004827EFO_0000474G40.91————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameOPICAPONE
INNopicapone
Description
Opicapone is a ring assembly and an oxadiazole.
Classification
Small molecule
Drug classcatechol-O-methyltransferase (COMT) inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Cc1c(Cl)c(C)[n+]([O-])c(Cl)c1-c1noc(-c2cc(O)c(O)c([N+](=O)[O-])c2)n1
Identifiers
PDB—
CAS-ID923287-50-7
RxCUI—
ChEMBL IDCHEMBL1089318
ChEBI ID—
PubChem CID135565903
DrugBankDB11632
UNII IDY5929UIJ5N (ChemIDplus, GSRS)
Target
Agency Approved
COMT
COMT
Organism
Homo sapiens
Gene name
COMT
Gene synonyms
NCBI Gene ID
1312
Protein name
catechol O-methyltransferase
Protein synonyms
epididymis secretory sperm binding protein Li 98n, testicular tissue protein Li 42
Uniprot ID
Q9BWC7
Mouse ortholog
Comt (12846)
catechol O-methyltransferase (Q91XH4)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 281 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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960 adverse events reported
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