Glycopyrronium bromide
Highest phase reached
Approved
Drug type
Small molecule
First approval year
1961
- First approval year
- 1961
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Glycopyrronium bromide
- Molecular weight
- 398.34
- Structure (SMILES)
- C[N+]1(C)CCC(OC(=O)C(O)(c2ccccc2)C2CCCC2)C1.[Br-]
- cuvposa
- Cuvposa
- dartisla odt
- Dartisla odt
- enurev breezhaler
- Enurev breezhaler
- glycopyrrolate
- Glycopyrrolate
- glycopyrrolate component of prevduo
- Glycopyrrolate component of prevduo
- glycopyrrolate component of utibron
- Glycopyrrolate component of utibron
- Glycopyrronium bromide component of bevespi aerosphere glycopyrrolate
- glycopyrronium bromide component of bevespi aerosphere glycopyrrolate
- Glycopyrronium bromide component of breztri glycopyrrolate
- glycopyrronium bromide component of breztri glycopyrrolate
- Glycopyrronium bromide component of prevduo glycopyrrolate
- glycopyrronium bromide component of prevduo glycopyrrolate
- glycopyrronium bromide component of qva 149
- Glycopyrronium bromide component of qva-149
- glycopyrronium bromide component of qva149
- Glycopyrronium bromide component of qva149
- glycopyrronium bromide component of trimbow
- Glycopyrronium bromide component of trimbow
- glycopyrronium bromide component of ultibro
And 19 more, listed on the interactive page.
- ad 237
- AD 237
- AD-237
- ahr 504
- AHR-504
- bromure de glycopyrronium
- Bromure de glycopyrronium
- bromuro de glicopirronio
- Bromuro de glicopirronio
- chf 5259
- CHF 5259
- CHF-5259
- chf5259
- CHF5259
- glycopyrrolate
- Glycopyrrolate
- Glycopyrrolate (14 μg)
- Glycopyrrolate (42.5 μg)
- Glycopyrrolate (85 μg)
- Glycopyrrolate 0.2 MG
- Glycopyrrolate 21.25 mcg
- Glycopyrrolate 42.5 mcg
- glycopyrrolate erythro
- Glycopyrrolate Injection
- Glycopyrrolate, erythro-
And 35 more, listed on the interactive page.
- CAS registry numbers
- 596-51-0
- ChEMBL ID
- CHEMBL1201027
- InChIKey
- VPNYRYCIDCJBOM-UHFFFAOYSA-M
- Applicant
- JOURNEY
- Approval date
- 28 Jun 2018
- Application number
- NDA210361
- Status
- Authorised
- Status date
- 28 Sept 2012
- Authorisation date
- 28 Sept 2012
- Approved indications
- Tovanor Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
- Product number
- EMEA/H/C/002690
- Authorisation holder
- Novartis Europharm Limited
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Pulmonary Disease, Chronic Obstructive
European medicines record
- Patents
- 11
- Designations
- 1
- Earliest recorded loss of exclusivity
- 7 Dec 2036
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- glycopyrrolate
- Type
- Synthetic organic
- Drug name stem
- -ium; -onium
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Parenteral
- topical
- Action
- Antagonist
- Action type
- Antagonist
- Target
- M2 receptor
- Gene symbol
- CHRM2
- Protein identifier
- P08172
- Affinity units
- pIC50
- Primary target
- Yes
- Action
- Antagonist
- Action type
- Antagonist
- Target
- M4 receptor
- Gene symbol
- CHRM4
- Protein identifier
- P08173
- Affinity units
- pKi
- Primary target
- Yes
- Action
- Antagonist
- Action type
- Antagonist
- Target
- M5 receptor
- Gene symbol
- CHRM5
- Protein identifier
- P08912
- Affinity units
- pKi
- Primary target
- Yes
- Action
- Antagonist
- Action type
- Antagonist
- Target
- M1 receptor
- Gene symbol
- CHRM1
- Protein identifier
- P11229
- Affinity units
- pIC50
- Primary target
- Yes
- Action
- Antagonist
- Action type
- Antagonist
- Target
- M3 receptor
- Gene symbol
- CHRM3
- Protein identifier
- P20309
- Affinity units
- pIC50
- Primary target
- Yes
- Mechanism
- Muscarinic acetylcholine receptor M1 antagonist
- Action type
- Antagonist
- Target
- Muscarinic acetylcholine receptor M1
- Protein identifier
- P11229
- Mechanism
- Muscarinic acetylcholine receptor M3 antagonist
- Action type
- Antagonist
- Target
- Muscarinic acetylcholine receptor M3
- Protein identifier
- P20309
- Mechanism
- Muscarinic acetylcholine receptor M1 antagonist
- Action type
- Antagonist
- Target
- Muscarinic acetylcholine receptor M1
- Mechanism
- Muscarinic acetylcholine receptor M3 antagonist
- Action type
- Antagonist
- Target
- Muscarinic acetylcholine receptor M3
- Action type
- Antagonist
- Gene symbol
- CHRM2
- Protein identifier
- P08172
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Antagonist
- Gene symbol
- CHRM4
- Protein identifier
- P08173
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Antagonist
- Gene symbol
- CHRM5
- Protein identifier
- P08912
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Antagonist
- Gene symbol
- CHRM1
- Protein identifier
- P11229
- Organism
- Homo sapiens
- Target development level
- Clinical
- Action type
- Antagonist
- Gene symbol
- CHRM3
- Protein identifier
- P20309
- Organism
- Homo sapiens
- Target development level
- Clinical
- Condition
- Pulmonary Disease, Chronic Obstructive
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000341
- Subject identifier
- D029424
- Condition
- Kidney Diseases
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003086
- Subject identifier
- D007674
- Condition
- Bronchitis, Chronic
- Highest recorded phase
- 4
- Condition identifier
- EFO:0006505
- Subject identifier
- D029481
- Condition
- Burns
- Highest recorded phase
- 3
- Condition identifier
- EFO:0009516
- Subject identifier
- D002056
- Condition
- Digestive System Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0010282
- Subject identifier
- D004066
- Condition
- Hyperhidrosis
- Highest recorded phase
- 2
- Condition identifier
- HP:0000975
- Subject identifier
- D006945
- Condition
- Postoperative Nausea and Vomiting
- Highest recorded phase
- 1
- Condition identifier
- HP:0002017
- Subject identifier
- D020250
- Condition
- Sialorrhea
- Highest recorded phase
- 4
- Condition identifier
- HP:0002307
- Subject identifier
- D012798
- Condition
- Headache
- Highest recorded phase
- 2
- Condition identifier
- HP:0002315
- Subject identifier
- D006261
- Condition
- Lung Diseases, Obstructive
- Highest recorded phase
- 4
- Condition identifier
- HP:0006536
- Subject identifier
- D008173
- Condition
- Depressive Disorder
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0002050
- Subject identifier
- D003866
- Condition
- Asthma
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0004979
- Subject identifier
- D001249
- Condition identifier
- EFO_0000341
- Condition identifier
- EFO_0000464
- Condition identifier
- EFO_0003086
- Highest recorded phase
- 1
- Condition identifier
- EFO_0006505
- Condition identifier
- EFO_0009516
- Highest recorded phase
- 3
- Condition identifier
- EFO_0009661
- Condition identifier
- EFO_0010282
- Condition identifier
- EFO_0010282
- Highest recorded phase
- 4
- Condition identifier
- EFO_0022917
- Condition identifier
- EFO_1001289
- Condition identifier
- HP_0000975
- Highest recorded phase
- 2
- Condition identifier
- HP_0001945
- Condition identifier
- HP_0002017
- Condition identifier
- HP_0002019
- Highest recorded phase
- 1
- Condition identifier
- HP_0002094
- Highest recorded phase
- 3
- Condition identifier
- HP_0002307
- Condition identifier
- HP_0002307
- Highest recorded phase
- 4
- Condition identifier
- HP_0006536
- Condition identifier
- HP_0006536
- Highest recorded phase
- 4
- Condition identifier
- HP_0012735
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0000960
- Highest recorded phase
- 0
- Condition identifier
- MONDO_0002050
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0002492
- Condition identifier
- MONDO_0003781
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0004849
- Highest recorded phase
- 4
And 12 more, listed on the interactive page.
- Event
- abscess
- Reports
- 27
- Reporting signal score
- 50.0958
- Event
- affective disorder
- Reports
- 15
- Reporting signal score
- 31.5547
- Event
- allergy to animal
- Reports
- 6
- Reporting signal score
- 21.2285
- Event
- anaphylactic reaction
- Reports
- 38
- Reporting signal score
- 32.7273
- Event
- angioplasty
- Reports
- 7
- Reporting signal score
- 20.1192
- Event
- angle closure glaucoma
- Reports
- 11
- Reporting signal score
- 26.0876
- Event
- ankle fracture
- Reports
- 15
- Reporting signal score
- 25.1499
- Event
- arthritis
- Reports
- 66
- Reporting signal score
- 105.248
- Event
- asthma
- Reports
- 386
- Reporting signal score
- 1,206.6
- Event
- asthma-chronic obstructive pulmonary disease overlap syndrome
- Reports
- 27
- Reporting signal score
- 154.52
- Event
- blood count abnormal
- Reports
- 34
- Reporting signal score
- 68.0935
- Event
- blood immunoglobulin e increased
- Reports
- 37
- Reporting signal score
- 147.324
- Event
- blood pressure increased
- Reports
- 55
- Reporting signal score
- 47.6754
- Event
- blood pressure systolic increased
- Reports
- 48
- Reporting signal score
- 113.866
- Event
- blood test abnormal
- Reports
- 29
- Reporting signal score
- 68.3659
- Event
- bradycardia
- Reports
- 41
- Reporting signal score
- 32.0345
- Event
- bradycardia foetal
- Reports
- 7
- Reporting signal score
- 21.0008
- Event
- breath sounds abnormal
- Reports
- 30
- Reporting signal score
- 97.1349
- Event
- bronchial disorder
- Reports
- 16
- Reporting signal score
- 61.7967
- Event
- bronchial haemorrhage
- Reports
- 15
- Reporting signal score
- 74.5171
- Event
- bronchial neoplasm
- Reports
- 15
- Reporting signal score
- 89.1657
- Event
- bronchiectasis
- Reports
- 39
- Reporting signal score
- 121.052
- Event
- bronchitis
- Reports
- 37
- Reporting signal score
- 33.3351
- Event
- cardiac arrest
- Reports
- 24
- Reporting signal score
- 24.9589
- Event
- cardiac disorder
- Reports
- 25
- Reporting signal score
- 20.5515
And 104 more, listed on the interactive page.
- NCT00501852
- NCT00545311
- NCT00558285
- NCT00570778
- NCT00856193
- NCT00871182
- NCT00929110
- NCT01005901
- NCT01085045
- NCT01119937
- NCT01120691
- NCT01154127
- NCT01176903
- NCT01349803
- NCT01349816
- NCT01350128
- NCT01398111
- NCT01476813
- NCT01513460
- NCT01529632
- NCT01566604
- NCT01566773
- NCT01587079
- NCT01613326
- NCT01697696
And 44 more, listed on the interactive page.
- Hydrogen bond acceptors
- 3
- Hydrogen bond donors
- 1
- Polar surface area
- 46.53
- Calculated partition coefficient (ALogP)
- 2.46
- Prodrug
- No
- Chirality
- Racemic
- Inorganic
- No
- Rule-of-five violations
- 0
- Rotatable bonds
- 4
- Heavy atoms
- 24
- Molecular formula
- C19H28BrNO3
- Monoisotopic mass
- 397.12526
- Natural product
- No
- Recorded assays
- 1,554
- Active assays
- 33
- Confirmatory
- Screening
- Summary
- Adjuvants, Anesthesia
- Muscarinic Antagonists
Related records
Trials (202)
- "Low Dose Sugammadex Combined With Neostigmine and Glycopyrrolate Versus Full Dose Sugammadex for Reversal of Rocuronium-induced Neuromuscular Blockade: a Cost Saving Strategy"
- 1-year Study to Assess the Efficacy, Safety, and Tolerability of Glycopyrronium Bromide (NVA237) in Chronic Obstructive Pulmonary Disease (COPD)
- A 12 Week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation.
- A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium 62.5 Microgram (mcg) Compared With Glycopyrronium 44 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
- A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation
- A 6-week Dose Ranging Study of CHF 5259 pMDI in Subjects With Chronic Obstructive Pulmonary Disease
- A Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis
- A Phase II Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Single Inhaled Doses of Ensifentrine-glycopyrrolate Fixed Dose Combination, Ensifentrine, and Glycopyrrolate in Subjects With Chronic Obstructive Pulmonary Disease
- A Phase II Study to Investigate Lung Function With 2 Different Doses of Inhaled Glycopyrronium Taken With BFF Compared to BFF in Participants of 4 to Less Than 12 Years of Age With Asthma
- A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD
- A Phase IIb Study of Glycopyrrolate Inhalation Solution Over 1 Week in Subjects With COPD
- A Randomized, Multicenter, Open-label, Parallel-group, 12-week Study to Assess the Efficacy and Safety of Switching From Tiotropium to QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) in Symptomatic Mild to Moderate COPD Patients
- A RCT to Compare the Effectiveness of Nebulized Anticholinergics for Cough Suppression During Flexible Bronchoscopy
- A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD
- A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis
- A Study of the Efficacy and Safety of NVA237 in Patients With Moderate to Severe COPD
- A Study to Assess the Effects of PT001 and PT005 MDI on Specific Image Based Parameters in Subjects With Moderate to Severe COPD
- A Study to Assess the Efficacy and Safety of HRG2005 Inhalation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
- A Study to Assess the Efficacy, Safety and Tolerability of Once-daily (q.d.) QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
- A Study to Assess the Pulmonary Distribution of Budesonide, Glycopyrronium and Formoterol Fumarate
Approved for (4)
- Chronic bronchitis
- Chronic obstructive pulmonary disease
- Hepatobiliary disorder
- Obstructive lung disease
In development for (4)
- Asthma Phase 3
- Burn Phase 3
- Depressive disorder Phase 1
- Kidney disorder Phase 1