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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
Therapeutic Area
MeSH
respiratory tract diseasesD012140
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Tudorza
Combinations
Duaklir
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Aclidinium bromide
Tradename
Company
Number
Date
Products
TUDORZA PRESSAIRCovis PharmaN-202450 RX2012-07-23
1 products, RLD, RS
Aclidinium bromide
+
Formoterol fumarate
Tradename
Company
Number
Date
Products
DUAKLIR PRESSAIRCovis PharmaN-210595 RX2019-03-29
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
duaklir pressairNew Drug Application2022-01-25
tudorza pressairNew Drug Application2021-02-23
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
bronchial spasm—D001986—
chronic obstructive pulmonary diseaseEFO_0000341D029424J44.9
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Aclidinium Bromide, Tudorza Pressair, Covis
100859742029-03-13DPU-2513
110005172029-03-13DPU-2513
80518512027-04-22DP
RE464172025-02-10DS, DPU-2513
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
No data
Clinical
Clinical Trials
41 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_0000341J44.9—9199239
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SmokingD012907EFO_0003768F17——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
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 nameACLIDINIUM
INNaclidinium 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 classmuscarinic 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-ID320345-99-1
RxCUI—
ChEMBL IDCHEMBL1194325
ChEBI ID65346
PubChem CID11519741
DrugBankDB08897
UNII IDUQW7UF9N91 (ChemIDplus, GSRS)
Target
Agency Approved
CHRM3
CHRM3
Organism
Homo sapiens
Gene name
CHRM3
Gene synonyms
NCBI Gene ID
1131
Protein name
muscarinic acetylcholine receptor M3
Protein synonyms
acetylcholine receptor, muscarinic 3, m3 muscarinic receptor
Uniprot ID
Q9HB60
Mouse ortholog
Chrm3 (12671)
muscarinic acetylcholine receptor M3 (Q9ERZ3)
Alternate
CHRM4
CHRM4
CHRM2
CHRM2
CHRM5
CHRM5
CHRM1
CHRM1
Organism
Homo sapiens
Gene name
CHRM4
Gene synonyms
NCBI Gene ID
1132
Protein name
muscarinic acetylcholine receptor M4
Protein synonyms
acetylcholine receptor, muscarinic 4
Uniprot ID
Q4VBK7
Mouse ortholog
Chrm4 (12672)
muscarinic acetylcholine receptor M4 (Q64056)
Variants
Clinical Variant
No data
Financial
Duaklir - AstraZeneca
$
€
£
₣
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Tudorza - AstraZeneca
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 788 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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27,963 adverse events reported
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