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
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)
Labels
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
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 disease | D029424 | EFO_0000341 | J44.9 | 4 | 12 | 36 | 24 | 4 | 77 |
| Asthma | D001249 | EFO_0000270 | J45 | 3 | 15 | 4 | 2 | — | 23 |
| Healthy volunteers/patients | — | 4 | — | — | 1 | — | 5 | ||
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | — | — | 1 | — | 1 |
| Hypoxia | D000860 | R09.02 | — | — | — | 1 | — | 1 | |
| Dyspnea | D004417 | HP_0002094 | R06.0 | — | — | — | 1 | — | 1 |
| Tachycardia | D013610 | HP_0001649 | R00.0 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obstructive lung diseases | D008173 | HP_0006536 | — | 2 | 2 | — | — | 2 | |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | 1 | — | — | 1 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatic insufficiency | D048550 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | INDACATEROL |
| INN | indacaterol |
| 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 class | bronchodilators (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-ID | 312753-06-3 |
| RxCUI | 1114326 |
| ChEMBL ID | CHEMBL1095777 |
| ChEBI ID | 68575 |
| PubChem CID | 6918554 |
| DrugBank | DB05039 |
| UNII ID | 8OR09251MQ (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)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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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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