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Glycopyrronium

Generic Name
Glycopyrronium
Brand Names
Bevespi, Breztri, Cuvposa, Dartisla, Enurev Breezhaler, Glycate, Glyrx, Lonhala, Prevduo, Qbrexza, Robinul, Robinul Forte, Seebri Breezhaler, Sialanar, Tovanor Breezhaler, Ultibro, Ulunar Breezhaler, Trimbow, Bevespi Aerosphere, Riltrava Aerosphere, Zimbus Breezhaler, Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.), Xoterna Breezhaler, Enerzair Breezhaler
Drug Type
Small Molecule
Chemical Formula
C19H28NO3
CAS Number
740028-90-4
Unique Ingredient Identifier
A14FB57V1D

Overview

Glycopyrronium, also known as NVA237 or glycopyrrolate, is a racemic mixture of two enantiomers. They are both quaternary ammonium compounds and long acting muscarinic antagonists. It is one of the most commonly prescribed anticholinergic medications. Early research into glycopyrronium use was for its indication as an adjunct therapy in the treatment of peptic ulcers. Later research, taking advantage of the systemic distribution of muscarinic receptors through the body, found that glycopyrronium could also be used for reducing sweat gland, oral, airway, and gastric secretions; as well as reducing cardiac inhibitory reflexes; and reducing bronchoconstriction in COPD. Glycopyrronium is commonly prescribed as a first line treatment for a wide variety indications and is considered to have a wider therapeutic window than tiotropium. Glycopyrronium was originally granted FDA approval on 11 August 1961.

Background

Glycopyrronium, also known as NVA237 or glycopyrrolate, is a racemic mixture of two enantiomers. They are both quaternary ammonium compounds and long acting muscarinic antagonists. It is one of the most commonly prescribed anticholinergic medications. Early research into glycopyrronium use was for its indication as an adjunct therapy in the treatment of peptic ulcers. Later research, taking advantage of the systemic distribution of muscarinic receptors through the body, found that glycopyrronium could also be used for reducing sweat gland, oral, airway, and gastric secretions; as well as reducing cardiac inhibitory reflexes; and reducing bronchoconstriction in COPD. Glycopyrronium is commonly prescribed as a first line treatment for a wide variety indications and is considered to have a wider therapeutic window than tiotropium. Glycopyrronium was originally granted FDA approval on 11 August 1961.

Indication

Glycopyrronium formulated as a topical cloth is indicated to treat primary axillary hyperhidrosis in patients ≥9 years, and an inhalational solution is indicated for long term maintenance of airflow obstruction in COPD. A glycopyrronium intravenous and intramuscular injection is indicated in adults and pediatric patients to reduce the volume and acidity of gastric secretions, reduce airway secretions, and block cardiac inhibitory reflexes during the induction of anesthesia and intubation; to treat surgically-induced, drug-induced, or vagal reflex associated arrhythmias intraoperatively; and to prevent peripheral muscarinic effects of cholinergic drugs. The same injection is indicated in adults as an adjunct therapy in the treatment of peptic ulcers, as is an orally disintegrating tablet formulation. An oral solution is indicated to treat excessive drooling associated with neurologic conditions in patients aged 3-16 years. Glycopyrronium and budesonide can be formulated with formoterol fumarate for the maintenance of COPD.

Associated Conditions

  • Airway Obstruction
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Increased upper airway secretion
  • Peptic Ulcer
  • Primary Axillary Hyperhidrosis
  • Sialorrhea
  • Cardiac vagal inhibitory reflexes
  • Cardiac vagal inhibitory reflexes caused by General Surgery
  • Cardiac vagal inhibitory reflexes caused by Medication
  • Gastric secretions
  • Peripheral muscarinic effects

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/01/22
N/A
Recruiting
Chiesi Bulgaria
2024/11/07
N/A
Recruiting
Chiesi Hungary Ltd.
2024/08/09
Phase 2
Completed
2024/08/01
Phase 4
Not yet recruiting
2024/04/22
Phase 2
Not yet recruiting
Post Graduate Institute of Medical Education and Research, Chandigarh
2024/04/08
Early Phase 1
Recruiting
James J. Peters Veterans Affairs Medical Center
2024/04/08
Phase 3
Active, not recruiting
James J. Peters Veterans Affairs Medical Center
2024/02/01
Not Applicable
Completed
Zhuan Zhang
2024/12/16
Phase 4
Not yet recruiting
2023/09/21
Phase 1
Active, not recruiting
Jie Chen

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Alembic Labs LLC
15955-305
ORAL
1 mg in 1 1
12/9/2020
Lupin Pharmaceuticals, Inc.
70748-138
INTRAVENOUS
1 mg in 5 mL
2/16/2023
NorthStar Rx LLC
16714-998
INTRAVENOUS, INTRAMUSCULAR
0.2 mg in 1 mL
12/8/2022
BE Pharmaceuticals Inc.
71839-125
INTRAMUSCULAR, INTRAVENOUS
1 mg in 5 mL
12/21/2021
Meitheal Pharmaceuticals Inc.
71288-414
INTRAVENOUS, INTRAMUSCULAR
0.2 mg in 1 mL
7/6/2021
Nivagen Pharmaceuticals, Inc.
75834-196
INTRAMUSCULAR, INTRAVENOUS
0.2 mg in 1 mL
10/29/2021
Meitheal Pharmaceuticals Inc.
71288-407
INTRAVENOUS, INTRAMUSCULAR
0.2 mg in 1 mL
12/6/2022
Ranbaxy Pharmaceuticals Inc.
63304-211
ORAL
2 mg in 1 1
1/3/2013
Stason Pharmaceuticals
60763-482
ORAL
2 mg in 1 1
12/13/2021
Piramal Critical Care Inc
66794-205
INTRAMUSCULAR, INTRAVENOUS
0.2 mg in 1 mL
12/21/2023

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Glycopyrronium Bromide Powder for Inhalation
国药准字HJ20180002
化学药品
吸入粉雾剂
7/1/2021
Glycopyrronium Bromide Powder for Inhalation
国药准字HJ20180003
化学药品
吸入粉雾剂
7/1/2021
Glycopyrrolate Tablets
国药准字H43020557
化学药品
片剂
4/25/2020
Glycopyrrolate Tablets
国药准字H43020891
化学药品
片剂
7/7/2020
Glycopyrrolate Injection
国药准字H20203546
化学药品
注射剂
11/2/2020
Glycopyrrolate Injection
国药准字H20203497
化学药品
注射剂
9/25/2020
Glycopyrrolate Injection
国药准字H20203545
化学药品
注射剂
11/2/2020
Glycopyrrolate Injection
国药准字H20213016
化学药品
注射剂
1/12/2021

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
GLYCOPYRROLATE ACCORD glycopyrrolate 0.2 mg/1 mL injection ampoules
237760
Medicine
A
6/6/2016
SEEBRI BREEZHALER glycopyrronium (as bromide) 50 microgram powder for inhalation (in capsule) blister
191517
Medicine
A
11/12/2012
ENERZAIR BREEZHALER 114/46/136 indacaterol/glycopyrronium/mometasone furoate 114/46/136 microgram powder for inhalation in capsule with inhaler
319001
Medicine
A
10/20/2020
ENERZAIR BREEZHALER 114/46/68 indacaterol/glycopyrronium/mometasone furoate 114/46/68 microgram powder for inhalation in capsule with inhaler
319002
Medicine
A
10/20/2020
GLYCOPYRROLATE ACCORD glycopyrrolate 0.6 mg/3 mL injection ampoules
237403
Medicine
A
6/6/2016
ULTIBRO BREEZHALER 110/50 indacaterol (as maleate)/ glycopyrronium (as bromide) 110 microgram / 50 microgram powder for inhalation in hard capsule
206449
Medicine
A
3/21/2014
ROBINUL glycopyrronium bromide (glycopyrrolate) 0.2mg/1mL injection ampoule
163586
Medicine
A
11/20/2009
BREZTRI AEROSPHERE 160/7.2/5 budesonide 160 mcg/glycopyrronium 7.2 mcg/formoterol fumarate dihydrate 5 mcg per actuation inhalation pressurised metered dose inhaler
339070
Medicine
A
7/19/2021
NOVISTIG glycopyrronium bromide (glycopyrrolate)/neostigmine methylsulfate 0.5 mg/2.5 mg per 1 mL injection solution ampoule
303637
Medicine
A
8/20/2019
Robinul 0.2mg/1mL injection
184356
Medicine
A
10/6/2011
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