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Glycopyrrolate
Aerosphere, Cuvposa, Dartisla, Glyrx-pf, Lonhala Magnair, 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
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
digestive system diseasesD004066
respiratory tract diseasesD012140
hereditary congenital and neonatal diseases and abnormalitiesD009358
Trade Name
FDA
EMA
Cuvposa, Dartisla, Glyrx-pf, Lonhala magnair, Robinul (generic drugs available since 1986-07-23, discontinued: 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)
Budesonide
+
Formoterol fumarate
+
Glycopyrrolate
Tradename
Company
Number
Date
Products
BREZTRI AEROSPHEREAstraZenecaN-212122 RX2020-07-23
1 products, RLD, RS
Formoterol fumarate
+
Glycopyrrolate
Tradename
Company
Number
Date
Products
BEVESPI AEROSPHEREAstraZenecaN-208294 RX2016-04-25
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
DARTISLA ODTEdenbridge PharmaceuticalsN-215019 RX2021-12-16
1 products, RLD, RS
GLYRX-PFExela Pharma SciencesN-210997 RX2018-07-11
4 products, RLD, RS
GLYCOPYRROLATEFresenius KabiN-214919 RX2022-04-21
1 products, RLD, RS
CUVPOSAMerzN-022571 RX2010-07-28
1 products, RLD, RS
LONHALA MAGNAIR KITSunovion Respiratory DevelopmentN-208437 RX2017-12-05
1 products, RLD, RS
Show 3 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
PREVDUOSlayback PharmaN-216903 RX2023-02-23
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
bevespi aerosphereNew Drug Application2020-11-05
cuvposaNew Drug Application2020-06-08
dartisla odtNew Drug Application2021-12-09
glyrx-pfNew Drug Application2018-08-01
lonhala magnairNew Drug Application2020-12-10
prevduoNew Drug Application2023-02-23
robinul robinul forteNew Drug Application2021-06-01
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
drug-induced abnormalitiesD000014
peptic ulcerHP_0004398D010437K27
respiratory tract diseasesD012140
Agency Specific
FDA
EMA
Expiration
Code
BUDESONIDE / FORMOTEROL FUMARATE / GLYCOPYRROLATE, BREZTRI AEROSPHERE, ASTRAZENECA AB
2023-07-23NC
Patent Expiration
Patent
Expires
Flag
FDA Information
Glycopyrrolate / Neostigmine Methylsulfate, Prevduo, Slayback Pharma Llc
104563542038-10-25DP
111100542038-10-25DP
Budesonide / Formoterol Fumarate / Glycopyrrolate, Breztri Aerosphere, Astrazeneca Ab
113314422038-05-10DP
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, Sunovion Resp
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
85115812023-11-08DP
Glycopyrrolate, Seebri, Novartis
81828382028-10-20DP
84797302028-10-11DP
Glycopyrrolate / Indacaterol Maleate, Utibron, Novartis
68787212025-02-25DS, DPU-1773
Glycopyrrolate, Cuvposa, Merz Pharms
76385522023-08-20U-1076
78163962023-08-20U-1076
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
149 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_0000341J44.992328663
Neuromuscular blockadeD0191481910
SialorrheaD012798HP_0002307K11.7121115
AnesthesiaD0007581315
General anesthesiaD00076811114
Spinal anesthesiaD000775123
NeoplasmsD009369C8022
Urinary bladder neoplasmsD001749C67112
Delayed emergence from anesthesiaD055191112
ArthritisD001168EFO_0005856M05-M1411
Show 19 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AsthmaD001249EFO_0000270J451426
Disease progressionD01845011
BurnsD002056T30.011
Elective surgical proceduresD01755811
Replacement arthroplasty kneeD01964511
Replacement arthroplasty hipD01964411
Blood coagulationD001777GO_000759611
Cerebral palsyD002547G8011
Intellectual disabilityD008607F7311
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HyperhidrosisD006945HP_0000975123
Parkinson diseaseD010300EFO_0002508G2011
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Spinal cord injuriesD013119EFO_100191944
Neurogenic bowelD055496EFO_1001061K59.244
Healthy volunteers/patients33
ConstipationD003248HP_0002019K59.022
Renal insufficiencyD051437HP_0000083N1911
Fecal incontinenceD005242R1511
DepressionD003863F33.911
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypotensionD007022EFO_0005251I9511
RhytidoplastyD01536111
Critical illnessD01663811
Heart failureD006333EFO_0003144I5011
Acute cholecystitisD041881EFO_1001289K81.011
FeverD005334HP_0001945R50.911
Brain neoplasmsD001932EFO_0003833C7111
Intracranial aneurysmD002532EFO_0003870I67.111
Non-small-cell lung carcinomaD00228911
Drug-related side effects and adverse reactionsD064420T88.711
Show 1 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameGLYCOPYRROLATE
INNglycopyrronium bromide
Description
Glycopyrronium bromide is a quaternary ammonium salt composed of 3-{[cyclopentyl(hydroxy)phenylacetyl]oxy}-1,1-dimethylpyrrolidin-1-ium and bromide ions in a 1:1 ratio. It is a quaternary ammonium salt and an organic bromide salt.
Classification
Small molecule
Drug classAntimuscarinic agent
Image (chem structure or protein)
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
RxCUI4955
ChEMBL IDCHEMBL1201027
ChEBI ID
PubChem CID11693
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
Protein name
muscarinic acetylcholine receptor M5
Protein synonyms
acetylcholine receptor, muscarinic 5
Uniprot ID
Mouse ortholog
Chrm5 (213788)
muscarinic acetylcholine receptor M5 (Q920H4)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Seebri - Novartis
$
£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,250 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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918 adverse events reported
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