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
Trade Name
FDA
EMA
Cuvposa, Dartisla, Glyrx-pf, Lonhala magnair, Robinul (generic drugs available since 1986-07-23, discontinued: Seebri)
CombinationsBevespi 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 AEROSPHERE | AstraZeneca | N-212122 RX | 2020-07-23 | 1 products, RLD, RS |
Formoterol fumarate
+
Glycopyrrolate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
BEVESPI AEROSPHERE | AstraZeneca | N-208294 RX | 2016-04-25 | 1 products, RLD, RS |
Glycopyrrolate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
ROBINUL | Casper Pharma | N-012827 RX | 1982-01-01 | 1 products, RLD |
ROBINUL FORTE | Casper Pharma | N-012827 RX | 1982-01-01 | 1 products, RLD |
DARTISLA ODT | Edenbridge Pharmaceuticals | N-215019 RX | 2021-12-16 | 1 products, RLD, RS |
GLYRX-PF | Exela Pharma Sciences | N-210997 RX | 2018-07-11 | 4 products, RLD, RS |
GLYCOPYRROLATE | Fresenius Kabi | N-214919 RX | 2022-04-21 | 1 products, RLD, RS |
CUVPOSA | Merz | N-022571 RX | 2010-07-28 | 1 products, RLD, RS |
LONHALA MAGNAIR KIT | Sunovion Respiratory Development | N-208437 RX | 2017-12-05 | 1 products, RLD, RS |
Show 3 discontinued
Glycopyrrolate
+
Indacaterol maleate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
UTIBRON | Novartis | N-207930 DISCN | 2015-10-29 | 1 products, RLD |
Hide discontinued
Glycopyrrolate
+
Neostigmine methylsulfate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
PREVDUO | Slayback Pharma | N-216903 RX | 2023-02-23 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
bevespi aerosphere | New Drug Application | 2020-11-05 |
cuvposa | New Drug Application | 2020-06-08 |
dartisla odt | New Drug Application | 2021-12-09 |
glyrx-pf | New Drug Application | 2018-08-01 |
lonhala magnair | New Drug Application | 2020-12-10 |
prevduo | New Drug Application | 2023-02-23 |
robinul robinul forte | New Drug Application | 2021-06-01 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
drug-induced abnormalities | — | D000014 | — |
peptic ulcer | HP_0004398 | D010437 | K27 |
respiratory tract diseases | — | D012140 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
BUDESONIDE / FORMOTEROL FUMARATE / GLYCOPYRROLATE, BREZTRI AEROSPHERE, ASTRAZENECA AB | |||
2023-07-23 | NC |
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Glycopyrrolate / Neostigmine Methylsulfate, Prevduo, Slayback Pharma Llc | |||
10456354 | 2038-10-25 | DP | |
11110054 | 2038-10-25 | DP | |
Budesonide / Formoterol Fumarate / Glycopyrrolate, Breztri Aerosphere, Astrazeneca Ab | |||
11331442 | 2038-05-10 | DP | |
8815258 | 2031-03-17 | U-2889 | |
8324266 | 2030-05-28 | U-2889 | |
8703806 | 2030-05-28 | U-2889 | |
8808713 | 2030-05-28 | DP | U-2889 |
9415009 | 2030-05-28 | U-2889 | |
9463161 | 2030-05-28 | DP | U-2889 |
10716753 | 2030-05-28 | DP | U-2889 |
Glycopyrrolate, Lonhala Magnair Kit, Sunovion Resp | |||
10744277 | 2036-12-07 | DP | U-2941 |
10688518 | 2036-11-12 | DP | |
10376661 | 2035-09-14 | DP | |
9604018 | 2033-05-16 | DP | |
9168556 | 2032-09-01 | DP | |
9789270 | 2030-10-30 | DP | |
10940110 | 2029-02-26 | DP | U-1773 |
9265900 | 2028-12-07 | DP | |
11278683 | 2026-08-16 | DP | |
7931212 | 2025-11-25 | DP | |
7458372 | 2024-11-18 | DP | |
8511581 | 2023-11-08 | DP | |
Glycopyrrolate, Seebri, Novartis | |||
8182838 | 2028-10-20 | DP | |
8479730 | 2028-10-11 | DP | |
Glycopyrrolate / Indacaterol Maleate, Utibron, Novartis | |||
6878721 | 2025-02-25 | DS, DP | U-1773 |
Glycopyrrolate, Cuvposa, Merz Pharms | |||
7638552 | 2023-08-20 | U-1076 | |
7816396 | 2023-08-20 | U-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
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 disease | D029424 | EFO_0000341 | J44.9 | 9 | 23 | 28 | 6 | — | 63 |
Neuromuscular blockade | D019148 | — | — | 1 | 9 | — | 10 | ||
Sialorrhea | D012798 | HP_0002307 | K11.7 | 1 | 2 | 1 | 1 | 1 | 5 |
Anesthesia | D000758 | — | — | 1 | 3 | 1 | 5 | ||
General anesthesia | D000768 | — | 1 | 1 | 1 | 1 | 4 | ||
Spinal anesthesia | D000775 | — | — | — | 1 | 2 | 3 | ||
Neoplasms | D009369 | C80 | — | — | — | 2 | — | 2 | |
Urinary bladder neoplasms | D001749 | C67 | — | — | — | 1 | 1 | 2 | |
Delayed emergence from anesthesia | D055191 | — | — | — | 1 | 1 | 2 | ||
Arthritis | D001168 | EFO_0005856 | M05-M14 | — | — | — | 1 | — | 1 |
Show 19 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Asthma | D001249 | EFO_0000270 | J45 | 1 | 4 | 2 | — | — | 6 |
Disease progression | D018450 | — | — | 1 | — | — | 1 | ||
Burns | D002056 | T30.0 | — | — | 1 | — | — | 1 | |
Elective surgical procedures | D017558 | — | — | 1 | — | — | 1 | ||
Replacement arthroplasty knee | D019645 | — | — | 1 | — | — | 1 | ||
Replacement arthroplasty hip | D019644 | — | — | 1 | — | — | 1 | ||
Blood coagulation | D001777 | GO_0007596 | — | — | 1 | — | — | 1 | |
Cerebral palsy | D002547 | G80 | — | — | 1 | — | — | 1 | |
Intellectual disability | D008607 | F73 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Hyperhidrosis | D006945 | HP_0000975 | 1 | 2 | — | — | — | 3 | |
Parkinson disease | D010300 | EFO_0002508 | G20 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Spinal cord injuries | D013119 | EFO_1001919 | 4 | — | — | — | — | 4 | |
Neurogenic bowel | D055496 | EFO_1001061 | K59.2 | 4 | — | — | — | — | 4 |
Healthy volunteers/patients | — | 3 | — | — | — | — | 3 | ||
Constipation | D003248 | HP_0002019 | K59.0 | 2 | — | — | — | — | 2 |
Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
Fecal incontinence | D005242 | R15 | 1 | — | — | — | — | 1 | |
Depression | D003863 | F33.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Hypotension | D007022 | EFO_0005251 | I95 | — | — | — | — | 1 | 1 |
Rhytidoplasty | D015361 | — | — | — | — | 1 | 1 | ||
Critical illness | D016638 | — | — | — | — | 1 | 1 | ||
Heart failure | D006333 | EFO_0003144 | I50 | — | — | — | — | 1 | 1 |
Acute cholecystitis | D041881 | EFO_1001289 | K81.0 | — | — | — | — | 1 | 1 |
Fever | D005334 | HP_0001945 | R50.9 | — | — | — | — | 1 | 1 |
Brain neoplasms | D001932 | EFO_0003833 | C71 | — | — | — | — | 1 | 1 |
Intracranial aneurysm | D002532 | EFO_0003870 | I67.1 | — | — | — | — | 1 | 1 |
Non-small-cell lung carcinoma | D002289 | — | — | — | — | 1 | 1 | ||
Drug-related side effects and adverse reactions | D064420 | T88.7 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | GLYCOPYRROLATE |
INN | glycopyrronium 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 class | Antimuscarinic 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-ID | 596-51-0 |
RxCUI | 4955 |
ChEMBL ID | CHEMBL1201027 |
ChEBI ID | — |
PubChem CID | 11693 |
DrugBank | DBSALT001183 |
UNII ID | V92SO9WP2I (ChemIDplus, GSRS) |
Target
Agency Approved
CHRM5
CHRM5
CHRM1
CHRM1
CHRM4
CHRM4
CHRM3
CHRM3
CHRM2
CHRM2
Alternate
No data
Variants
Clinical Variant
No data
Financial
Seebri - Novartis
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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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