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, Glycopyrrolate, Glyrx-pf, Robinul (discontinued: Dartisla, Glycopyrrolate, Glyrx-pf, Robinul, 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)
Formoterol fumarate
+
Glycopyrrolate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| BEVESPI AEROSPHERE | AstraZeneca | N-208294 RX | 2016-04-25 | 1 products, RLD, RS |
Budesonide
+
Formoterol fumarate
+
Glycopyrrolate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| BREZTRI AEROSPHERE | AstraZeneca | N-212122 RX | 2020-07-23 | 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 |
| GLYRX-PF | Exela Pharma Sciences | N-210997 RX | 2018-07-11 | 3 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 | 2024-12-19 |
| dartisla odt | New Drug Application | 2023-10-19 |
| glycate | ANDA | 2024-01-17 |
| glycopyrrolate | ANDA | 2025-01-08 |
| glycopyrrolate 1ml | ANDA | 2023-10-23 |
| glycopyrrolate oral solution | ANDA | 2024-01-17 |
| glyrx-pf | New Drug Application | 2018-08-01 |
Show 2 more
Indications
FDA
EMA
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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
295 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 | 24 | 53 | 23 | 19 | 132 |
| Obstructive lung diseases | D008173 | HP_0006536 | — | 9 | 19 | 46 | 14 | 12 | 99 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | 1 | 14 | 38 | 10 | 9 | 72 |
| Asthma | D001249 | EFO_0000270 | J45 | 4 | 5 | 9 | 3 | 4 | 24 |
| Neuromuscular blockade | D019148 | — | — | — | 1 | 2 | 16 | 2 | 21 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | 5 | — | 1 | 1 | — | 7 |
| Vomiting | D014839 | HP_0002013 | R11.1 | 1 | 1 | — | 5 | — | 6 |
| Sialorrhea | D012798 | HP_0002307 | K11.7 | 1 | 2 | 1 | 1 | 2 | 6 |
| Nausea | D009325 | HP_0002018 | R11.0 | 1 | 1 | — | 4 | — | 5 |
| General anesthesia | D000768 | — | — | — | — | 3 | 1 | 1 | 5 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperhidrosis | D006945 | HP_0000975 | — | 2 | 7 | 4 | — | — | 13 |
| Neurogenic bowel | D055496 | EFO_1001061 | K59.2 | 5 | — | 1 | — | — | 6 |
| Constipation | D003248 | HP_0002019 | K59.0 | 3 | — | 1 | — | — | 4 |
| Fecal incontinence | D005242 | — | R15 | 2 | — | 1 | — | — | 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 |
| Hip fractures | D006620 | EFO_0003964 | S72.00 | — | — | 1 | — | — | 1 |
| Blood coagulation | D001777 | GO_0007596 | — | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Respiratory aspiration | D053120 | EFO_1001839 | — | 1 | 1 | — | — | — | 2 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | 1 | — | — | — | 2 |
| Intracranial hemorrhages | D020300 | EFO_0000551 | I62 | — | 1 | — | — | — | 1 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | 1 | — | — | — | 1 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 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 |
| Urologic surgical procedures | D013520 | — | — | — | 1 | — | — | — | 1 |
| Skin diseases | D012871 | — | L00-L99 | — | 1 | — | — | — | 1 |
Show 5 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 5 | — | — | — | — | 5 |
| Snoring | D012913 | — | R06.83 | 1 | — | — | — | — | 1 |
| Gastrointestinal diseases | D005767 | — | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Bradycardia | D001919 | HP_0001662 | R00.1 | — | — | — | — | 4 | 4 |
| Gallbladder diseases | D005705 | EFO_0003832 | K82.9 | — | — | — | — | 2 | 2 |
| Acute cholecystitis | D041881 | EFO_1001289 | K81.0 | — | — | — | — | 2 | 2 |
| Cholecystitis | D002764 | HP_0001082 | K81 | — | — | — | — | 2 | 2 |
| Rhytidoplasty | D015361 | — | — | — | — | — | — | 1 | 1 |
| Hysterectomy | D007044 | EFO_0003881 | — | — | — | — | — | 1 | 1 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | — | — | — | 1 | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | — | — | 1 | 1 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | — | — | — | 1 | 1 |
| Abdominal hernia | D046449 | — | K46 | — | — | — | — | 1 | 1 |
Show 26 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
No data
Variants
No data
Financial
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Seebri – Novartis
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Bevespi aerosphere – AstraZeneca
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Breztri 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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Trends
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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530 adverse events reported
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