MedPath

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
Drug Type
Small Molecule
Chemical Formula
C19H28NO3
CAS Number
740028-90-4
Unique Ingredient Identifier
A14FB57V1D
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

AstraZeneca to Present Groundbreaking Respiratory Research at ATS 2025 Conference

• AstraZeneca will showcase over 75 abstracts at the American Thoracic Society International Conference, highlighting advancements in asthma and COPD treatments including Airsupra and Breztri. • The BATURA Phase IIIb trial demonstrates Airsupra's potential to transform asthma rescue treatment by reducing systemic corticosteroid exposure compared to albuterol alone. • New data shows prompt initiation of Breztri after COPD exacerbations reduces subsequent exacerbations and cardiopulmonary events, addressing COPD as the third leading cause of death globally.

AstraZeneca's Trixeo Aerosphere Becomes First Inhaled Respiratory Medicine with Near-Zero Climate Impact Propellant

• UK regulatory authorities have approved AstraZeneca's Trixeo Aerosphere as the first pressurized metered-dose inhaler using a next-generation propellant with 99.9% lower Global Warming Potential than current options. • The COPD treatment maintains clinical bioequivalence to the original formulation while achieving a carbon footprint comparable to propellant-free inhalers, addressing both patient needs and environmental concerns. • This approval marks the first step in AstraZeneca's commitment to transition its entire pressurized metered-dose inhaler portfolio to near-zero climate impact propellants by 2030 as part of its Ambition Zero Carbon strategy.

Verona Pharma to Present Comprehensive Analyses of Ohtuvayre in COPD at ATS 2025

• Verona Pharma will present ten posters at ATS 2025, including seven analyses from Phase 3 ENHANCE studies demonstrating Ohtuvayre's efficacy in diverse COPD patient populations. • Ohtuvayre (ensifentrine), a first-in-class dual PDE3 and PDE4 inhibitor, showed significant improvements in lung function and reduced exacerbation rates in patients with COPD, including those with comorbid conditions. • The analyses highlight Ohtuvayre's effectiveness as both monotherapy and in patients with comorbidities such as cardiac disorders and type 2 diabetes, representing the first novel inhaled mechanism for COPD treatment in over 20 years.

AstraZeneca's Breztri Shows Significant Improvement in Phase III Asthma Trials

• Breztri Aerosphere met all primary endpoints in KALOS and LOGOS Phase III trials, demonstrating statistically significant improvement in lung function for patients with uncontrolled asthma compared to dual-combination therapies. • The triple-combination therapy (budesonide/glycopyrronium/formoterol fumarate) could potentially address a critical unmet need, as nearly half of asthma patients on dual therapy remain uncontrolled. • AstraZeneca plans to share the full trial results with regulatory authorities, potentially expanding Breztri's approved indications beyond its current use in COPD treatment across 80+ countries.

Zydus Healthcare Secures CDSCO Approval for Phase III Trials of Two COPD Combination Therapies

• Zydus Healthcare has received approval from India's CDSCO panel to conduct Phase III clinical trials for Glycopyrrolate-Indacaterol metered dose inhalation, a maintenance treatment for COPD patients. • The company also secured approval for Phase III trials of Vilanterol-Umeclidinium powder inhalation, with the condition that severe COPD patients with inspiratory flow rates below 30 L/min be excluded. • Both combination therapies target bronchodilation through different mechanisms - LAMA/LABA combinations that improve airflow obstruction in COPD by relaxing bronchial smooth muscles.

Fasenra Poised to Revolutionize COPD Treatment Following Promising Phase III Data

• AstraZeneca's Fasenra (benralizumab) is set to transform COPD treatment, targeting eosinophilic inflammation and potentially reshaping treatment standards. • Fasenra, an IL-5-targeting monoclonal antibody, has shown promise in addressing critical safety and efficacy gaps in eosinophilic COPD patients. • GlobalData projects Fasenra could generate $1.28 billion in US sales by 2033 if approved, marking a significant advancement in COPD care. • AstraZeneca's respiratory and immunology portfolio, including Fasenra and Breztri Aerosphere, drives growth and addresses unmet needs in COPD management.

Medicare to Negotiate Single Price for Novo's Semaglutide Products Including Ozempic and Wegovy

• Medicare has selected semaglutide as one of 15 drugs for its second round of price negotiations, treating all formulations including Ozempic, Wegovy, and Rybelsus as a single product. • The negotiations will establish a unified "maximum fair price" for all semaglutide products, impacting Novo Nordisk's medications that currently list at $998-$1,349 per month. • CMS's approach focuses on the drug's active moiety rather than individual brand names, aiming to prevent "product hopping" and ensure consistent pricing across different formulations.

Verona Pharma's Ohtuvayre Shows Strong Launch in COPD Market

• Verona Pharma reports Ohtuvayre achieved approximately $36 million in net product sales for Q4 2024 and $42 million for the full year, marking a strong initial uptake. • Over 3,500 unique healthcare professionals prescribed Ohtuvayre to a broad COPD population, with over 16,000 prescriptions filled in 2024, indicating rapid adoption. • Verona Pharma is advancing its COPD program with a Phase 2b trial of ensifentrine combined with glycopyrrolate planned for Q3 2025, expanding treatment options. • The company's cash reserves are robust, with approximately $400 million in cash and cash equivalents as of December 31, 2024, supporting ongoing development.

FDA Grants Priority Review to CUTX-101 for Menkes Disease, Offering Hope for Rare Pediatric Condition

• The FDA has accepted Sentynl Therapeutics' NDA for CUTX-101, granting priority review for the treatment of Menkes disease, a rare genetic disorder. • Clinical trials of CUTX-101 demonstrated an almost 80% reduction in mortality risk compared to untreated patients, significantly improving overall survival. • CUTX-101 has been granted multiple designations, including Breakthrough Therapy and Orphan Drug, highlighting its potential to address a critical unmet need. • Cyprium Therapeutics is eligible to receive up to $129 million in milestone payments and royalties, retaining ownership of a potential Priority Review Voucher.

Study finds no clinical advantage of budesonide inhaler over fluticasone in COPD

A recent study published in BMJ compared the effectiveness and safety of two single-inhaler triple therapies for COPD, finding that fluticasone-umeclidinium-vilanterol resulted in fewer COPD exacerbations compared to budesonide-glycopyrrolate-formoterol, without increasing the risk of pneumonia.

Critical Treatment Gap Persists for T2-Low Asthma Despite Therapeutic Advances

• T2-low asthma remains significantly underdiagnosed and undertreated due to the absence of reliable biomarkers, creating a stark contrast to the therapeutic advances seen in T2-high asthma. • Several pharmaceutical companies, including Areteia Therapeutics and AstraZeneca, are exploring novel treatment approaches, with dexpramipexole and Breztri showing potential for addressing T2-low asthma. • Current diagnostic challenges, treatment adherence issues, and the lack of targeted biological therapies highlight the urgent need for improved diagnostic tools and therapeutic options for T2-low asthma patients.

FDA Approves Journey Medical's Emrosi™ for Rosacea Treatment

• The FDA has approved Emrosi™ (minocycline hydrochloride extended-release capsules, 40 mg) for treating inflammatory lesions of rosacea in adults. • Journey Medical anticipates launching Emrosi™ in late Q1 or early Q2 of 2025, expanding their dermatology-focused product portfolio. • Clinical data presented at the 44th Fall Clinical Dermatology Conference highlighted Emrosi's higher dermal concentration compared to doxycycline. • The approval marks a significant advancement in rosacea treatment, addressing a prevalent dermatological condition.
© Copyright 2025. All Rights Reserved by MedPath