Tudorza pressair, Eklira genuair(aclidinium)
Duaklir, Duaklir Genuair, Genuair, Tudorza (aclidinium) is a small molecule pharmaceutical. Aclidinium was first approved as Eklira genuair on 2012-07-20. It is used to treat bronchial spasm and chronic obstructive pulmonary disease in the USA. It has been approved in Europe to treat chronic obstructive pulmonary disease. The pharmaceutical is active against muscarinic acetylcholine receptor M3. In addition, it is known to target muscarinic acetylcholine receptor M4, muscarinic acetylcholine receptor M2, muscarinic acetylcholine receptor M5, and muscarinic acetylcholine receptor M1.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Tudorza
CombinationsDuaklir
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Aclidinium bromide
+
Formoterol fumarate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DUAKLIR PRESSAIR | Covis Pharma | N-210595 RX | 2019-03-29 | 1 products, RLD, RS |
Aclidinium bromide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TUDORZA PRESSAIR | Covis Pharma | N-202450 RX | 2012-07-23 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| duaklir pressair | New Drug Application | 2022-08-01 |
| tudorza pressair | New Drug Application | 2022-08-01 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| chronic obstructive pulmonary disease | EFO_0000341 | D029424 | J44.9 |
| asthma | EFO_0000270 | D001249 | J45 |
| bronchial spasm | — | D001986 | — |
Agency Specific
FDA
EMA
No data
ATC Codes
R: Respiratory system drugs
— R03: Drugs for obstructive airway diseases
— R03A: Adrenergics, inhalants
— R03AL: Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
— R03AL05: Formoterol and aclidinium bromide
— R03B: Other drugs for obstructive airway diseases, inhalants in atc
— R03BB: Anticholinergics inhalants for obstructive airway diseases
— R03BB05: Aclidinium bromide
HCPCS
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Clinical
Clinical Trials
55 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 | 2 | 10 | 22 | 12 | 5 | 51 |
| Obstructive lung diseases | D008173 | — | — | 1 | 7 | 20 | 9 | 3 | 40 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 1 | 7 | 19 | 6 | 2 | 35 |
| Chronic disease | D002908 | — | — | — | — | — | 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 |
| Smoking | D012907 | EFO_0004318 | — | — | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Asthma | D001249 | EFO_0000270 | J45 | 4 | — | — | — | — | 4 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Aclidinium |
| INN | aclidinium bromide |
| Description | Aclidinium bromide is a quaternary ammonium salt that is the bromide salt of aclidinium. A muscarinic acetylcholine M3 receptor antagonist, for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). It has a role as a muscarinic antagonist and a bronchodilator agent. It is a quaternary ammonium salt and an organic bromide salt. It contains an aclidinium. |
| Classification | Small molecule |
| Drug class | muscarinic receptor agonists/antagonists; quaternary ammonium derivatives: muscarinic receptor agonists/antagonists |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C(O[C@H]1C[N+]2(CCCOc3ccccc3)CCC1CC2)C(O)(c1cccs1)c1cccs1 |
Identifiers
| PDB | — |
| CAS-ID | 320345-99-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1194325 |
| ChEBI ID | 65346 |
| PubChem CID | 11519741 |
| DrugBank | DB08897 |
| UNII ID | UQW7UF9N91 (ChemIDplus, GSRS) |
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Tudorza – AstraZeneca
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Duaklir – AstraZeneca
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Estimated US medical usage
Aclidinium
Total medical expenditures per year (USD, in millions)
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Trends
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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5,900 adverse events reported
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