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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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Cuvposa, Dartisla, Glyrx-pf, Robinul (generic drugs available since 1986-07-23, discontinued: Dartisla, Lonhala magnair, 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 PEND | 2023-10-11 | 1 products |
| 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 |
Show 5 discontinued
Glycopyrrolate
+
Indacaterol maleate
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| bevespi aerosphere | New Drug Application | 2023-03-24 |
| bretzri | New Drug Application | 2020-07-23 |
| breztri | New Drug Application | 2022-01-26 |
| cuvposa | New Drug Application | 2023-09-13 |
| glycate | ANDA | 2024-01-17 |
| glycopyrrolate | ANDA | 2024-01-30 |
| glycopyrrolate 1ml | ANDA | 2023-10-23 |
| glycopyrrolate oral solution | ANDA | 2024-01-17 |
| glyrx-pf | New Drug Application | 2018-08-01 |
| robinul | New Drug Application | 2012-02-07 |
Show 1 more
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
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Glycopyrrolate / Neostigmine Methylsulfate, Prevduo, Azurity | |||
| 10456354 | 2038-10-25 | DP | |
| 11110054 | 2038-10-25 | DP | |
| Budesonide / Formoterol Fumarate / Glycopyrrolate, Breztri Aerosphere, Astrazeneca Ab | |||
| 11331442 | 2038-10-05 | DP | |
| 11833292 | 2038-10-05 | 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, Sumitomo Pharma Am | |||
| 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 | |
| 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 |
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
344 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 | 16 | 29 | 55 | 21 | 8 | 126 |
| Asthma | D001249 | EFO_0000270 | J45 | 4 | 6 | 10 | 3 | 3 | 24 |
| Neuromuscular blockade | D019148 | — | — | — | 1 | 2 | 13 | 5 | 21 |
| General anesthesia | D000768 | — | — | — | 4 | 3 | 1 | 4 | 12 |
| Anesthesia | D000758 | — | — | — | — | 2 | 3 | 3 | 8 |
| Sialorrhea | D012798 | HP_0002307 | K11.7 | 1 | 2 | 1 | 1 | 2 | 6 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | 4 | — | — | 1 | — | 5 |
| Postoperative nausea and vomiting | D020250 | EFO_0004888 | — | — | — | — | 4 | — | 4 |
| Spinal anesthesia | D000775 | — | — | — | — | 1 | 1 | 2 | 4 |
| Postoperative complications | D011183 | — | — | — | — | — | 2 | 2 | 4 |
Show 40 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperhidrosis | D006945 | HP_0000975 | — | 1 | 4 | 3 | — | — | 8 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | — | 1 | — | 2 | 3 |
| 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 | EFO_0003847 | F73 | — | — | 1 | — | — | 1 |
| Analgesia | D000698 | — | — | — | — | 1 | — | — | 1 |
Show 2 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | 1 | — | — | — | 2 |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | 2 | — | — | — | 2 |
| Severe acute respiratory syndrome-related coronavirus | D045473 | NCBITaxon_227859 | — | — | 1 | — | — | — | 1 |
| Intracranial hemorrhages | D020300 | EFO_0000551 | I62 | — | 1 | — | — | — | 1 |
| Brain ischemia | D002545 | EFO_0003883 | I67.82 | — | 1 | — | — | — | 1 |
| Intracranial vasospasm | D020301 | EFO_1000994 | G45.9 | — | 1 | — | — | — | 1 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | 1 | — | — | — | 1 |
| Skin diseases | D012871 | — | L00-L99 | — | 1 | — | — | — | 1 |
| Sweat gland diseases | D013543 | — | L74 | — | 1 | — | — | — | 1 |
| Surgical amputation | D000671 | — | — | — | 1 | — | — | — | 1 |
Show 3 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 5 | — | — | — | — | 5 |
| Neurogenic bowel | D055496 | EFO_1001061 | K59.2 | 4 | — | — | — | — | 4 |
| Constipation | D003248 | HP_0002019 | K59.0 | 2 | — | — | — | — | 2 |
| Fecal incontinence | D005242 | — | R15 | 1 | — | — | — | — | 1 |
| Snoring | D012913 | — | R06.83 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | — | — | — | 3 | 3 |
| Hypotension | D007022 | EFO_0005251 | I95 | — | — | — | — | 2 | 2 |
| Hip fractures | D006620 | EFO_0003964 | S72.00 | — | — | — | — | 2 | 2 |
| Gallbladder diseases | D005705 | EFO_0003832 | K82.9 | — | — | — | — | 2 | 2 |
| Critical illness | D016638 | — | — | — | — | — | — | 2 | 2 |
| Acute cholecystitis | D041881 | EFO_1001289 | K81.0 | — | — | — | — | 2 | 2 |
| Bradycardia | D001919 | HP_0001662 | R00.1 | — | — | — | — | 2 | 2 |
| Rhytidoplasty | D015361 | — | — | — | — | — | — | 1 | 1 |
| Delirium | D003693 | — | R41.0 | — | — | — | — | 1 | 1 |
| Hysterectomy | D007044 | EFO_0003881 | — | — | — | — | — | 1 | 1 |
Show 59 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Glycopyrrolate |
| INN | glycopyrronium 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 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 | — |
| ChEMBL ID | CHEMBL1201027 |
| ChEBI ID | — |
| PubChem CID | 3494 |
| DrugBank | DBSALT001183 |
| UNII ID | V92SO9WP2I (ChemIDplus, GSRS) |
Target
Agency Approved
CHRM5
CHRM5
CHRM1
CHRM1
CHRM4
CHRM4
CHRM3
CHRM3
CHRM2
CHRM2
Alternate
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Variants
No data
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Breztri aerosphere – AstraZeneca
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Seebri – Novartis
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Bevespi aerosphere – AstraZeneca
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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 7,064 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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7,278 adverse events reported
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