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Drug ReportsUmeclidinium
Anoro ellipta, Incruse ellipta (previously incruse)(umeclidinium)
Anoro, Anoro Ellipta, Ellipta, Incruse, Incruse Ellipta, Laventair, Laventair Ellipta, Rolufta, Rolufta Ellipta (umeclidinium) is a small molecule pharmaceutical. Umeclidinium was first approved as Anoro ellipta on 2013-12-18. It is used to treat chronic bronchitis and pulmonary emphysema in the USA. It has been approved in Europe to treat chronic obstructive pulmonary disease. It is known to target muscarinic acetylcholine receptor M5, muscarinic acetylcholine receptor M4, muscarinic acetylcholine receptor M1, muscarinic acetylcholine receptor M3, and muscarinic acetylcholine receptor M2.
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3M
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
respiratory tract diseasesD012140
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Incruse ellipta
Combinations
Anoro ellipta, Trelegy ellipta
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Umeclidinium bromide
+
Vilanterol trifenatate
Tradename
Company
Number
Date
Products
ANORO ELLIPTAGSKN-203975 RX2013-12-18
1 products, RLD, RS
Umeclidinium bromide
Tradename
Company
Number
Date
Products
INCRUSE ELLIPTAGSKN-205382 RX2014-04-30
1 products, RLD, RS
Fluticasone furoate
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Umeclidinium bromide
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Vilanterol trifenatate
Tradename
Company
Number
Date
Products
TRELEGY ELLIPTAGSKN-209482 RX2017-09-18
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
anoro elliptaNew Drug Application2023-06-02
incruse elliptaNew Drug Application2023-12-13
trelegy elliptaNew Drug Application2023-06-02
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
chronic bronchitis—D029481J42
pulmonary emphysema—D011656J43
allergic rhinitis perennialEFO_1001417D012221J30.89
Agency Specific
FDA
EMA
Expiration
Code
FLUTICASONE FUROATE / UMECLIDINIUM BROMIDE / VILANTEROL TRIFENATATE, TRELEGY ELLIPTA, GLAXOSMITHKLINE
2023-09-09I-843, NS
Patent Expiration
Patent
Expires
Flag
FDA Information
Fluticasone Furoate / Umeclidinium Bromide / Vilanterol Trifenatate, Trelegy Ellipta, Glaxosmithkline
97507262030-11-29DP
110902942030-11-29U-3202, U-3203
87462422030-10-11DP
85342812030-03-08DP
81619682028-02-05DP
74888272027-12-18DS, DP
93333102027-10-02DP
85113042027-06-14DPU-1476, U-2954
81832572025-07-27U-1476, U-2128, U-2129
74393932025-05-21DS, DPU-1476, U-2127, U-2957
74984402025-04-27DS, DP
83095722025-04-27U-1476, U-2129
Umeclidinium Bromide, Incruse Ellipta, Glaxo Grp England
82015562029-02-05DP
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
— R03AL03: Vilanterol and umeclidinium bromide
— R03AL08: Vilanterol, umeclidinium bromide and fluticasone furoate
— R03B: Other drugs for obstructive airway diseases, inhalants in atc
— R03BB: Anticholinergics inhalants for obstructive airway diseases
— R03BB07: Umeclidinium bromide
HCPCS
No data
Clinical
Clinical Trials
109 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_0000341J44.9161236201093
Lung diseasesD008171HP_0002088J98.4263012555
Obstructive lung diseasesD008173HP_0006536—14169433
AsthmaD001249EFO_0000270J452561—13
Respiratory aspirationD053120EFO_1001839————2—2
Heart failureD006333HP_0001635I50———1—1
Respiratory tract diseasesD012140—————1—1
Respiration disordersD012120—J00-J99———1—1
Chronic bronchitisD029481—J42———1—1
BronchitisD001991—J40———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD002289————1——1
Lung neoplasmsD008175HP_0100526C34.90——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HyperhidrosisD006945HP_0000975—12———3
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal insufficiencyD051437HP_0000083N191————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameUmeclidinium
INNumeclidinium bromide
Description
Umeclidinium bromide is a quaternary ammonium salt that is the bromide salt of umeclidinium. Used in combination with vilanterol for long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease. It has a role as a muscarinic antagonist. It is a quaternary ammonium salt and an organic bromide salt. It contains an umeclidinium.
Classification
Small molecule
Drug classmuscarinic receptor agonists/antagonists; quaternary ammonium derivatives: muscarinic receptor agonists/antagonists
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
OC(c1ccccc1)(c1ccccc1)C12CC[N+](CCOCc3ccccc3)(CC1)CC2
Identifiers
PDB—
CAS-ID869113-09-7
RxCUI1487512
ChEMBL IDCHEMBL1187833
ChEBI ID—
PubChem CID11519069
DrugBank—
UNII ID7AN603V4JV (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
CHRM5
CHRM5
CHRM4
CHRM4
CHRM1
CHRM1
CHRM3
CHRM3
CHRM2
CHRM2
Organism
Homo sapiens
Gene name
CHRM5
Gene synonyms
NCBI Gene ID
1133
Protein name
muscarinic acetylcholine receptor M5
Protein synonyms
acetylcholine receptor, muscarinic 5
Uniprot ID
Q96RG7
Mouse ortholog
Chrm5 (213788)
muscarinic acetylcholine receptor M5 (Q920H4)
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Trelegy ellipta – Innoviva
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Estimated US medical usage
Umeclidinium
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Vilanterol
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Fluticasone
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Refill frequency
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Price per prescription (USD)
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Umeclidinium
Total medical expenditures per year (USD, in millions)
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Price per prescription (USD)
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Umeclidinium
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Vilanterol
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,211 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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37,315 adverse events reported
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