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 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 4/23/2014 | ||
Authorised | 9/19/2013 | ||
Authorised | 7/17/2017 | ||
Authorised | 12/18/2018 | ||
Withdrawn | 4/23/2018 | ||
Authorised | 12/9/2020 | ||
Authorised | 12/9/2020 | ||
Authorised | 9/18/2013 | ||
Authorised | 7/3/2020 | ||
Authorised | 7/3/2020 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
ULTIBRO BREEZHALER INHALATION POWDER HARD CAPSULE 110/50 MCG | SIN14539P | CAPSULE | 50 mcg | 4/10/2014 | |
TRIMBOW PRESSURISED INHALATION SOLUTION 100/6/12.5 μg PER ACTUATION | SIN15924P | AEROSOL, METERED | 0.0125mg/actuation | 4/2/2020 | |
SEEBRI BREEZHALER INHALATION POWDER, HARD CAPSULE 50MCG | SIN14431P | CAPSULE | 50 mcg | 11/8/2013 | |
ENERZAIR BREEZHALER INHALATION POWDER, HARD CAPSULE 150 MCG /50 MCG /160 MCG | SIN16153P | POWDER, METERED | 50 mcg | 4/14/2021 | |
BREZTRI AEROSPHERE PRESSURISED INHALATION SUSPENSION 160 MCG/7.2 MCG/5 MCG per actuation | SIN16723P | AEROSOL, METERED | 7.2 μg/actuation | 3/2/2023 | |
TRIMBOW PRESSURISED INHALATION SOLUTION 200/6/12.5 μg PER ACTUATION | SIN17226P | AEROSOL, METERED | 0.01250mg/actuation | 4/30/2025 |
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. |