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Drug ReportsGlycopyrrolate
Glycopyrrolate
Aerosphere, Cuvposa, Dartisla, Glycopyrrolate, Glyrx-pf, Prevduo, Robinul, Utibron (glycopyrrolate) is a small molecule pharmaceutical. Glycopyrrolate was first approved as Robinul on 1982-01-01. It is used to treat drug-induced abnormalities, peptic ulcer, and respiratory tract diseases in the USA. The pharmaceutical is active against muscarinic acetylcholine receptor M5, muscarinic acetylcholine receptor M1, muscarinic acetylcholine receptor M4, muscarinic acetylcholine receptor M3, and muscarinic acetylcholine receptor M2.
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Novartis Pharmaceuticals
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
respiratory tract diseasesD012140
hereditary congenital and neonatal diseases and abnormalitiesD009358
Trade Name
FDA
EMA
Cuvposa, Glycopyrrolate, Glyrx-pf, Robinul (discontinued: Dartisla, Glycopyrrolate, Glyrx-pf, Robinul, Seebri)
Combinations
Bevespi aerosphere, Breztri aerosphere, Prevduo (discontinued: Utibron)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Formoterol fumarate
+
Glycopyrrolate
Tradename
Company
Number
Date
Products
BEVESPI AEROSPHEREAstraZenecaN-208294 RX2016-04-25
1 products, RLD, RS
Budesonide
+
Formoterol fumarate
+
Glycopyrrolate
Tradename
Company
Number
Date
Products
BREZTRI AEROSPHEREAstraZenecaN-212122 RX2020-07-23
1 products, RLD, RS
Glycopyrrolate
Tradename
Company
Number
Date
Products
ROBINULCasper PharmaN-012827 RX1982-01-01
1 products, RLD
ROBINUL FORTECasper PharmaN-012827 RX1982-01-01
1 products, RLD
GLYRX-PFExela Pharma SciencesN-210997 RX2018-07-11
3 products, RLD, RS
GLYCOPYRROLATEFresenius KabiN-214919 RX2022-04-21
1 products, RLD, RS
CUVPOSAMerzN-022571 RX2010-07-28
1 products, RLD, RS
Show 5 discontinued
Glycopyrrolate
+
Indacaterol maleate
Tradename
Company
Number
Date
Products
UTIBRONNovartisN-207930 DISCN2015-10-29
1 products, RLD
Hide discontinued
Glycopyrrolate
+
Neostigmine methylsulfate
Tradename
Company
Number
Date
Products
PREVDUOAzurityN-216903 RX2023-02-23
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
bevespi aerosphereNew Drug Application2023-03-24
bretzriNew Drug Application2020-07-23
breztriNew Drug Application2022-01-26
cuvposaNew Drug Application2024-12-19
dartisla odtNew Drug Application2023-10-19
glycateANDA2024-01-17
glycopyrrolateANDA2025-01-30
glycopyrrolate 1mlANDA2023-10-23
glycopyrrolate oral solutionANDA2024-01-17
glyrx-pfNew Drug Application2018-08-01
Show 2 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
respiratory tract diseases—D012140—
peptic ulcer—D010437K27
drug-induced abnormalities—D000014—
asthmaEFO_0000270D001249J45
bronchial spasm—D001986—
inflammatory bowel diseasesEFO_0003767D015212—
allergic rhinitis perennialEFO_1001417D012221J30.89
chronic bronchitis—D029481J42
pulmonary emphysema—D011656J43
urinary retention—D016055R33
Show 2 more
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Glycopyrrolate / Neostigmine Methylsulfate, Prevduo, Azurity
104563542038-10-25DP
111100542038-10-25DP
Budesonide / Formoterol Fumarate / Glycopyrrolate, Breztri Aerosphere, Astrazeneca Ab
113314422038-10-05DP
118332922038-10-05DP
88152582031-03-17U-2889
83242662030-05-28U-2889
87038062030-05-28U-2889
88087132030-05-28DPU-2889
94150092030-05-28U-2889
94631612030-05-28DPU-2889
107167532030-05-28DPU-2889
Glycopyrrolate, Lonhala Magnair Kit, Sumitomo Pharma Am
107442772036-12-07DPU-2941
106885182036-11-12DP
103766612035-09-14DP
96040182033-05-16DP
91685562032-09-01DP
97892702030-10-30DP
109401102029-02-26DPU-1773
92659002028-12-07DP
112786832026-08-16DP
79312122025-11-25DP
74583722024-11-18DP
Glycopyrrolate, Seebri, Novartis
81828382028-10-20DP
84797302028-10-11DP
Glycopyrrolate / Indacaterol Maleate, Utibron, Novartis
68787212025-02-25DS, DPU-1773
ATC Codes
A: Alimentary tract and metabolism drugs
— A03: Drugs for functional gastrointestinal disorders
— A03A: Drugs for functional gastrointestinal disorders
— A03AB: Synthetic anticholinergics, quaternary ammonium compounds for functional gastrointestinal disorders
— A03AB02: Glycopyrronium bromide
— A03C: Antispasmodics in combination with psycholeptics
— A03CA: Synthetic anticholinergic agents in combination with psycholeptics
— A03CA05: Glycopyrronium bromide and psycholeptics
R: Respiratory system drugs
— R03: Drugs for obstructive airway diseases
— R03A: Adrenergics, inhalants
— R03AL: Adrenergics in combination with anticholinergics incl. triple combinations with corticosteroids
— R03AL04: Indacaterol and glycopyrronium bromide
— R03AL07: Formoterol and glycopyrronium bromide
— R03AL09: Formoterol, glycopyrronium bromide and beclometasone
— R03AL11: Formoterol, glycopyrronium bromide and budesonide
— R03AL12: Indacaterol, glycopyrronium bromide and mometasone
— R03B: Other drugs for obstructive airway diseases, inhalants in atc
— R03BB: Anticholinergics inhalants for obstructive airway diseases
— R03BB06: Glycopyrronium bromide
HCPCS
Code
Description
J7642
Glycopyrrolate, inhalation solution, compounded product, administered through dme, concentrated form, per milligram
J7643
Glycopyrrolate, inhalation solution, compounded product, administered through dme, unit dose form, per milligram
Clinical
Clinical Trials
170 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_0000341J44.91311461924112
Obstructive lung diseasesD008173——10936121784
Lung diseasesD008171EFO_0003818J98.4—72681253
AsthmaD001249EFO_0000270J4543123930
Disease progressionD018450————11—2
SialorrheaD012798—K11.711—1—2
Postoperative nausea and vomitingD020250EFO_0004888————2—2
VomitingD014839—R11.1———2—2
NauseaD009325—R11.0———2—2
Critical illnessD016638—————1—1
Show 8 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HyperhidrosisD006945——164——11
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Respiratory aspirationD053120EFO_1001839—21———3
Skin diseasesD012871—L00-L99—1———1
Sweat gland diseasesD013543—L74—1———1
Surgical amputationD000671———1———1
Covid-19D000086382—U07.1—1———1
ColonoscopyD003113——11———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———5————5
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic diseaseD002908——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameGlycopyrrolate
INNglycopyrronium bromide
Description
2-cyclopentyl-2-hydroxy-2-phenylacetic acid (1,1-dimethyl-3-pyrrolidin-1-iumyl) ester is a member of benzenes.
Classification
Small molecule
Drug classAntimuscarinic agent
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
C[N+]1(C)CCC(OC(=O)C(O)(c2ccccc2)C2CCCC2)C1.[Br-]
Identifiers
PDB—
CAS-ID596-51-0
RxCUI—
ChEMBL IDCHEMBL1201027
ChEBI ID—
PubChem CID3494
DrugBankDBSALT001183
UNII IDV92SO9WP2I (ChemIDplus, GSRS)
Target
Agency Approved
CHRM5
CHRM5
CHRM1
CHRM1
CHRM4
CHRM4
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)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Seebri – Novartis
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Bevespi aerosphere – AstraZeneca
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Breztri aerosphere – AstraZeneca
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Tabular view
Estimated US medical usage
Glycopyrrolate
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,071 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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6,054 adverse events reported
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