Arformoterol
Arformoterol, Brovana (arformoterol) is a small molecule pharmaceutical. Arformoterol was first approved as Brovana on 2006-10-06. It is used to treat bronchial spasm, chronic bronchitis, and pulmonary emphysema in the USA. 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
Arformoterol, Brovana (discontinued: Arformoterol)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Arformoterol tartrate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| BROVANA | Lupin Research | N-021912 RX | 2006-10-06 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| arformoterol tartrate | ANDA | 2024-09-02 |
| arformoterol tartrate inhalation | ANDA | 2023-01-24 |
| arformoterol tartrate inhalation solution | ANDA | 2024-06-26 |
| bevespi aerosphere | New Drug Application | 2023-03-24 |
| bretzri | New Drug Application | 2020-07-23 |
| breyna | ANDA | 2020-09-24 |
| breztri | New Drug Application | 2022-01-26 |
| brovana | New Drug Application | 2024-04-15 |
| budesonide and formoterol fumarate dihydrate | NDA authorized generic | 2024-10-22 |
| duaklir pressair | New Drug Application | 2022-08-01 |
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| chronic bronchitis | — | D029481 | J42 |
| pulmonary emphysema | — | D011656 | J43 |
| bronchial spasm | — | D001986 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
No data
HCPCS
Code | Description |
|---|---|
| J7605 | Arformoterol, inhalation solution, fda approved final product, non-compounded, administered through dme, unit dose form, 15 micrograms |
Clinical
Clinical Trials
562 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Asthma | D001249 | EFO_0000270 | J45 | 23 | 50 | 114 | 48 | 46 | 273 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 24 | 47 | 88 | 58 | 39 | 248 |
| Obstructive lung diseases | D008173 | HP_0006536 | — | 14 | 33 | 66 | 42 | 26 | 177 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | 2 | 29 | 55 | 35 | 21 | 138 |
| Emphysema | D004646 | EFO_0000464 | J43 | — | — | 4 | 5 | — | 9 |
| Bronchitis | D001991 | — | J40 | — | — | 3 | 5 | — | 8 |
| Disease progression | D018450 | — | — | — | — | 1 | 3 | 3 | 7 |
| Cough-variant asthma | D000096823 | — | — | 1 | 1 | — | 3 | 2 | 6 |
| Pulmonary emphysema | D011656 | — | J43 | — | — | 2 | 4 | — | 6 |
| Chronic bronchitis | D029481 | — | J42 | — | — | 2 | 4 | — | 6 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Respiratory aspiration | D053120 | EFO_1001839 | — | 3 | 3 | 1 | — | 1 | 7 |
| Aspergillosis | D001228 | EFO_0007157 | B44 | — | 4 | 4 | — | — | 4 |
| Allergic bronchopulmonary aspergillosis | D001229 | EFO_0007140 | B44.81 | — | 4 | 4 | — | — | 4 |
| Pulmonary aspergillosis | D055732 | EFO_1001834 | — | — | 4 | 4 | — | — | 4 |
| Covid-19 | D000086382 | — | — | — | 2 | 2 | — | — | 3 |
| Infections | D007239 | EFO_0000544 | — | — | 1 | 1 | — | — | 2 |
| Communicable diseases | D003141 | — | — | — | 1 | 1 | — | — | 2 |
| Respiratory insufficiency | D012131 | HP_0002093 | J96.9 | — | — | 2 | — | — | 2 |
| Pneumonia | D011014 | EFO_0003106 | — | — | — | 1 | — | — | 1 |
| Recurrence | D012008 | — | — | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bronchiolitis obliterans | D001989 | EFO_0007183 | — | — | 3 | — | — | — | 3 |
| Bronchiolitis | D001988 | HP_0011950 | — | — | 3 | — | — | — | 3 |
| Bronchiolitis obliterans syndrome | D000092122 | — | — | — | 3 | — | — | — | 3 |
| Medication adherence | D055118 | EFO_0006344 | — | 2 | 2 | — | — | — | 2 |
| Interstitial lung diseases | D017563 | HP_0006530 | J84.89 | — | 1 | — | — | — | 1 |
| Cryptogenic organizing pneumonia | D018549 | EFO_1001300 | J84.116 | — | 1 | — | — | — | 1 |
| Organizing pneumonia | D000092124 | — | — | — | 1 | — | — | — | 1 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | 1 | — | — | — | 1 |
| Acute lung injury | D055371 | EFO_0004610 | — | — | 1 | — | — | — | 1 |
| Lung injury | D055370 | — | S27.30 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 8 | — | — | — | 2 | 10 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 1 | — | — | — | — | 1 |
| Precancerous conditions | D011230 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Allergic rhinitis | D065631 | — | J30.9 | — | — | — | — | 2 | 2 |
| Rhinitis | D012220 | EFO_0008521 | J31 | — | — | — | — | 2 | 2 |
| Chronic cough | D000096822 | — | — | — | — | — | — | 2 | 2 |
| Personal satisfaction | D010549 | — | — | — | — | — | — | 1 | 1 |
| Patient satisfaction | D017060 | — | — | — | — | — | — | 1 | 1 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | — | — | 1 | 1 |
| Hypoglycemia | D007003 | HP_0001943 | E16.2 | — | — | — | — | 1 | 1 |
| Bronchial hyperreactivity | D016535 | — | — | — | — | — | — | 1 | 1 |
| Hypertrophy | D006984 | EFO_0002460 | — | — | — | — | — | 1 | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Arformoterol |
| INN | arformoterol |
| Description | N-[2-hydroxy-5-(1-hydroxy-2-{[1-(4-methoxyphenyl)propan-2-yl]amino}ethyl)phenyl]formamide is a phenylethanoloamine having 4-hydroxy and 3-formamido substituents on the phenyl ring and an N-(4-methoxyphenyl)propan-2-yl substituent. It is a member of phenols, a member of formamides, a secondary amino compound, a secondary alcohol and a member of phenylethanolamines. |
| Classification | Small molecule |
| Drug class | bronchodilators (phenethylamine derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | COc1ccc(C[C@@H](C)NC[C@H](O)c2ccc(O)c(NC=O)c2)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 67346-49-0 |
| RxCUI | 25255 |
| ChEMBL ID | CHEMBL1363 |
| ChEBI ID | 408174 |
| PubChem CID | 3410 |
| DrugBank | DB01274 |
| UNII ID | 5ZZ84GCW8B (ChemIDplus, GSRS) |
Target
Agency Approved
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Variants
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Financial
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Estimated US medical usage
Arformoterol
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Additional graphs summarizing 8,012 documents
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Safety
Black-box Warning
Black-box warning for: Foradil
Adverse Events
Top Adverse Reactions
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1,345 adverse events reported
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