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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Commercial
Therapeutic Areas
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
Indications
FDA
EMA
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
149 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 | 15 | 48 | 31 | 9 | 104 |
| Obstructive lung diseases | D008173 | HP_0006536 | — | 2 | 11 | 47 | 21 | 3 | 82 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | 1 | 9 | 35 | 12 | 5 | 60 |
| Asthma | D001249 | EFO_0000270 | J45 | 3 | 17 | 12 | 2 | 4 | 37 |
| Healthy volunteers/patients | — | — | — | 4 | — | — | 1 | — | 5 |
| Dyspnea | D004417 | HP_0002094 | R06.0 | — | 1 | — | 2 | — | 3 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | 1 | 1 | — | 2 |
| Bronchiectasis | D001987 | HP_0002110 | J47 | — | — | — | 1 | — | 1 |
| Hypoxia | D000860 | HP_0012418 | R09.02 | — | — | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Respiratory aspiration | D053120 | EFO_1001839 | — | 1 | 1 | 1 | — | — | 2 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| Liver failure | D017093 | HP_0001399 | K72.9 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Exercise tolerance | D017079 | — | — | — | — | — | — | 2 | 2 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Indacaterol |
| INN | indacaterol |
| Description | Indacaterol is an ultra-long-acting beta-adrenoceptor agonist developed by Novartis. It needs to be taken only once a day, unlike the related drugs formoterol and salmeterol. It is licensed only for the treatment of chronic obstructive pulmonary disease (COPD) (long-term data in patients with asthma are thus far lacking). It is delivered as an aerosol formulation through a dry powder inhaler.
|
| 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 | — |
| ChEMBL ID | CHEMBL1095777 |
| ChEBI ID | 68575 |
| PubChem CID | 6433117 |
| 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
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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7,376 adverse events reported
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