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.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Cuvposa, Glycopyrrolate, Glyrx-pf, Robinul (discontinued: Dartisla, Glycopyrrolate, Glyrx-pf, Robinul, Seebri neohaler)
CombinationsBevespi aerosphere, Breztri aerosphere, Prevduo (discontinued: Utibron neohaler)
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 |
| ROBINUL | Hikma Pharmaceuticals | N-017558 RX | 1982-01-01 | 1 products, RLD |
| CUVPOSA | Merz | N-022571 RX | 2010-07-28 | 1 products, RLD, RS |
Show 4 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 | 2025-12-17 |
| glycopyrrolate 1ml | ANDA | 2023-10-23 |
| glycopyrrolate oral solution | ANDA | 2025-12-02 |
| glyrx-pf | New Drug Application | 2025-07-23 |
Show 2 more
Indications
FDA
EMA
Show 2 more
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
323 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
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 | 19 | 33 | 56 | 24 | 22 | 149 |
| Obstructive lung diseases | D008173 | — | — | 9 | 23 | 47 | 15 | 8 | 100 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 2 | 16 | 36 | 10 | 11 | 74 |
| Asthma | D001249 | EFO_0000270 | J45 | 4 | 8 | 9 | 3 | 5 | 27 |
| Neuromuscular blockade | D019148 | — | — | — | 1 | 2 | 16 | 5 | 24 |
| General anesthesia | D000768 | — | — | — | 4 | 3 | 1 | 2 | 10 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | 5 | — | 1 | 1 | — | 7 |
| Sialorrhea | D012798 | — | K11.7 | 1 | 2 | 1 | 1 | 2 | 6 |
| Anesthesia | D000758 | — | — | — | — | 2 | 2 | 2 | 6 |
| Vomiting | D014839 | — | R11.1 | 1 | 1 | — | 4 | — | 5 |
Show 51 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperhidrosis | D006945 | — | — | 2 | 5 | 1 | — | — | 8 |
| Neurogenic bowel | D055496 | EFO_1001061 | K59.2 | 5 | — | 1 | — | — | 6 |
| Constipation | D003248 | — | 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 |
Show 9 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal insufficiency | D051437 | — | N19 | 1 | 1 | — | — | — | 2 |
| Respiratory aspiration | D053120 | EFO_1001839 | — | 2 | 1 | — | — | — | 2 |
| Treatment-resistant schizophrenia | D000090663 | — | — | 1 | 1 | — | — | — | 1 |
| 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 |
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 |
| Encopresis | D004688 | — | F98.1 | 2 | — | — | — | — | 2 |
| 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 | — | R00.1 | — | — | — | — | 4 | 4 |
| Gallbladder diseases | D005705 | EFO_0003832 | K82.9 | — | — | — | — | 2 | 2 |
| Acute cholecystitis | D041881 | EFO_1001289 | K81.0 | — | — | — | — | 2 | 2 |
| Cholecystitis | D002764 | — | K81 | — | — | — | — | 2 | 2 |
| Intraoperative complications | D007431 | — | — | — | — | — | — | 2 | 2 |
| Acute kidney injury | D058186 | — | N17 | — | — | — | — | 1 | 1 |
| Rhytidoplasty | D015361 | — | — | — | — | — | — | 1 | 1 |
| Hysterectomy | D007044 | EFO_0003881 | — | — | — | — | — | 1 | 1 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | — | — | 1 | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | — | — | 1 | 1 |
Show 38 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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
Revenue by drug
$
€
£
â‚£
Seebri – Novartis
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Breztri – AstraZeneca
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Breztri aerosphere – AstraZeneca
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Bevespi aerosphere – AstraZeneca
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Estimated US medical usage
Glycopyrrolate
Total medical expenditures per year (USD, in millions)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 8,292 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
17,341 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use