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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 abnormalities—D000014—
peptic ulcerHP_0004398D010437K27
respiratory tract diseases—D012140—
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_0000341J44.9923286—63
Neuromuscular blockadeD019148——19—10
SialorrheaD012798HP_0002307K11.7121115
AnesthesiaD000758——1315
General anesthesiaD000768—11114
Spinal anesthesiaD000775———123
NeoplasmsD009369C80———2—2
Urinary bladder neoplasmsD001749C67———112
Delayed emergence from anesthesiaD055191———112
ArthritisD001168EFO_0005856M05-M14———1—1
Show 19 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AsthmaD001249EFO_0000270J45142——6
Disease progressionD018450——1——1
BurnsD002056T30.0——1——1
Elective surgical proceduresD017558——1——1
Replacement arthroplasty kneeD019645——1——1
Replacement arthroplasty hipD019644——1——1
Blood coagulationD001777GO_0007596——1——1
Cerebral palsyD002547G80——1——1
Intellectual disabilityD008607F73——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HyperhidrosisD006945HP_000097512———3
Parkinson diseaseD010300EFO_0002508G20—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Spinal cord injuriesD013119EFO_10019194————4
Neurogenic bowelD055496EFO_1001061K59.24————4
Healthy volunteers/patients—3————3
ConstipationD003248HP_0002019K59.02————2
Renal insufficiencyD051437HP_0000083N191————1
Fecal incontinenceD005242R151————1
DepressionD003863F33.91————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypotensionD007022EFO_0005251I95————11
RhytidoplastyD015361————11
Critical illnessD016638————11
Heart failureD006333EFO_0003144I50————11
Acute cholecystitisD041881EFO_1001289K81.0————11
FeverD005334HP_0001945R50.9————11
Brain neoplasmsD001932EFO_0003833C71————11
Intracranial aneurysmD002532EFO_0003870I67.1————11
Non-small-cell lung carcinomaD002289————11
Drug-related side effects and adverse reactionsD064420T88.7————11
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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
$
€
£
₣
Mock data
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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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