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Arcapta neohaler, Onbrez breezhaler(indacaterol)
Arcapta Neohaler, Breezhaler, Utibron (indacaterol) is a small molecule pharmaceutical. Indacaterol was first approved as Onbrez breezhaler on 2009-11-29. It is used to treat chronic bronchitis and pulmonary emphysema in the USA. It has been approved in Europe to treat asthma and chronic obstructive pulmonary disease. The pharmaceutical is active against beta-2 adrenergic receptor. In addition, it is known to target beta-1 adrenergic receptor.
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Novartis Pharmaceuticals
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
respiratory tract diseasesD012140
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Glycopyrrolate
+
Indacaterol maleate
Tradename
Company
Number
Date
Products
UTIBRONNovartisN-207930 DISCN2015-10-29
1 products, RLD
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Indacaterol maleate
Tradename
Company
Number
Date
Products
ARCAPTA NEOHALERNovartisN-022383 DISCN2011-07-01
1 products, RLD
Hide discontinued
Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
chronic bronchitisD029481J42
pulmonary emphysemaD011656J43
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Glycopyrrolate / Indacaterol Maleate, Utibron, Novartis
81828382028-10-20DP
84797302028-10-11DP
68787212025-02-25DS, DPU-1168, U-1773
ATC Codes
R: Respiratory system drugs
R03: Drugs for obstructive airway diseases
R03A: Adrenergics, inhalants
R03AC: Selective beta-2-adrenoreceptor agonist inhalants
R03AC18: Indacaterol
R03AK: Adrenergics inhalants in combination with corticosteroids or other drugs, excl. anticholinergics
R03AK14: Indacaterol and mometasone
R03AL: Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
R03AL04: Indacaterol and glycopyrronium bromide
R03AL12: Indacaterol, glycopyrronium bromide and mometasone
HCPCS
No data
Clinical
Clinical Trials
105 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic obstructive pulmonary diseaseD029424EFO_0000341J44.94123624477
AsthmaD001249EFO_0000270J453154223
Healthy volunteers/patients415
Lung diseasesD008171EFO_0003818J98.411
HypoxiaD000860R09.0211
DyspneaD004417HP_0002094R06.011
TachycardiaD013610HP_0001649R00.011
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Obstructive lung diseasesD008173HP_0006536222
Heart failureD006333EFO_0003144I5011
TuberculosisD014376EFO_0000774A15-A1911
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatic insufficiencyD04855011
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameINDACATEROL
INNindacaterol
Description
Indacaterol is a monohydroxyquinoline that consists of 5-[(1R)-2-amino-1-hydroxyethyl]-8-hydroxyquinolin-2-one having a 5,6-diethylindan-2-yl group attached to the amino function. Used as the maleate salt for treatment of chronic obstructive pulmonary disease. It has a role as a beta-adrenergic agonist and a bronchodilator agent. It is a quinolone, a monohydroxyquinoline, a member of indanes, a secondary alcohol and a secondary amino compound. It is a conjugate base of an indacaterol(1+).
Classification
Small molecule
Drug classbronchodilators (phenethylamine derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CCc1cc2c(cc1CC)CC(NC[C@H](O)c1ccc(O)c3[nH]c(=O)ccc13)C2
Identifiers
PDB
CAS-ID312753-06-3
RxCUI1114326
ChEMBL IDCHEMBL1095777
ChEBI ID68575
PubChem CID6918554
DrugBankDB05039
UNII ID8OR09251MQ (ChemIDplus, GSRS)
Target
Agency Approved
ADRB2
ADRB2
Organism
Homo sapiens
Gene name
ADRB2
Gene synonyms
ADRB2R, B2AR
NCBI Gene ID
Protein name
beta-2 adrenergic receptor
Protein synonyms
adrenergic, beta-2-, receptor, surface, adrenoceptor beta 2 surface, Beta-2 adrenoceptor, Beta-2 adrenoreceptor, catecholamine receptor
Uniprot ID
Mouse ortholog
Adrb2 (11555)
beta-2 adrenergic receptor (Q8BH38)
Alternate
ADRB1
ADRB1
Organism
Homo sapiens
Gene name
ADRB1
Gene synonyms
ADRB1R, B1AR
NCBI Gene ID
Protein name
beta-1 adrenergic receptor
Protein synonyms
adrenergic, beta-1-, receptor, Beta-1 adrenoceptor, Beta-1 adrenoreceptor
Uniprot ID
Mouse ortholog
Adrb1 (11554)
beta-1 adrenergic receptor (P34971)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 1,698 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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12 adverse events reported
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