Glenmark introduces world’s first nebulized triple therapy Nebzmart GFB Smartules for COPD

Finance Saathi Team

    25/Nov/2025

  • Glenmark introduces Nebzmart® GFB Smartules® and Glenmark Airz® FB Smartules®, the world’s first nebulized triple therapy for COPD.

  • Fixed-dose combination integrates Glycopyrronium, Formoterol, and Budesonide.

  • Designed for patients who struggle with MDI or DPI inhalers.

  • Clinical study shows rapid lung function improvement and better dyspnea control.

  • Launch reinforces Glenmark’s position in global respiratory innovation.

  • Supported by strong safety profile and simplified medication process.

Glenmark Pharmaceuticals Limited, a leading research-driven global pharmaceutical company headquartered in Mumbai, has announced a breakthrough in respiratory healthcare with the launch of Nebzmart® GFB Smartules® and Glenmark Airz® FB Smartules®. These two new products represent a historical milestone in COPD treatment, becoming the world’s first known nebulized fixed-dose triple therapy. Their introduction marks a major global achievement not just for the company but for the future of chronic respiratory treatment, especially for patients who require easy-to-administer, highly effective therapeutic solutions.

The launch marks the coming together of three essential COPD medications—Glycopyrronium, Formoterol, and Budesonide—into one single fixed-dose nebulized therapy that aims to address airway obstruction, reduce inflammation, improve lung capacity, and enhance symptom control. As COPD continues to be a leading cause of morbidity worldwide, the availability of such an innovative therapy positions Glenmark as one of the foremost pioneers in respiratory medicine.

A Global First in Nebulized COPD Treatment

For years, COPD management has relied heavily on multiple inhaled formulations delivered through devices such as Metered Dose Inhalers (MDIs) and Dry Powder Inhalers (DPIs). While these devices are effective when used correctly, many COPD patients struggle with coordination, timing, the force required to inhale the medication, or maintaining proper technique due to age, advanced disease stage, or physical limitations.

With the introduction of Nebzmart® GFB Smartules® and Glenmark Airz® FB Smartules®, Glenmark has addressed one of the most significant challenges facing COPD patients: the difficulty of using inhalers correctly. By offering a nebulized triple therapy, the company allows patients to receive effective treatment simply by breathing normally through a nebulizer—removing adherence issues related to inhaler technique.

This innovation is especially critical for elderly patients, those with compromised lung function, or individuals who find complex inhaler mechanisms difficult to manage. The therapy also reduces treatment burden by combining three medications into one, improving compliance and reducing the risk of treatment errors or skipped doses.

The Science Behind the Triple Combination

What makes this therapy groundbreaking is the integration of three proven, essential medicines:

1. Glycopyrronium

A long-acting muscarinic antagonist (LAMA) used to reduce airway constriction by relaxing airway muscles.

2. Formoterol

A long-acting beta-agonist (LABA) known for rapid onset bronchodilation, helping quickly relieve breathlessness.

3. Budesonide

An inhaled corticosteroid (ICS) that helps reduce inflammation, manage chronic symptoms, and decrease exacerbations.

Together, these medicines create a triple mechanism of action, targeting all major COPD-related complications in one therapy. This combination has been used in inhaler form in recent years, but Glenmark is the first in the world to bring it in a nebulized, fixed-dose format, providing a genuinely new route of administration backed by clinical evidence.

Clinical Study Validating the Therapy

The formulation was evaluated through a clinical study conducted across India, showing strong and promising outcomes. Key findings included:

  • Rapid improvement in lung function, measured through spirometric results.

  • Better control of breathlessness (dyspnea), significantly improving patient comfort.

  • Well-tolerated safety profile, suggesting its suitability for long-term management.

  • Higher patient satisfaction due to the ease of nebulizer use and reduced medication complexity.

Patients who typically struggle to operate MDIs or DPIs were able to use the nebulized therapy comfortably and with more consistent dosing accuracy. This aligns with the global shift in respiratory medicine toward more patient-friendly delivery mechanisms that do not compromise therapeutic potency.

Glenmark Leadership Speaks on the Milestone

Glenmark’s leadership has emphasized how this innovation reflects the company’s commitment to advancing global respiratory care.

Alok Malik, President & Business Head – India Formulations

He stated that innovation at Glenmark is rooted in reimagining therapeutic access and enhancing patient care. According to him, introducing the world’s first nebulized triple therapy reinforces Glenmark’s standing as a leader in respiratory healthcare. He highlighted the product's potential to transform treatment for COPD patients who need a simpler and more accessible form of therapy without compromising on efficacy or safety.

Dr. Monika Tandon, Global Head of Clinical Development

Dr. Tandon noted that the therapy represents a significant leap in managing COPD, especially due to its superior convenience and proven clinical outcomes. She stressed the importance of nebulized medications in improving adherence and providing more consistent relief, particularly for advanced COPD cases where inhaler technique may be compromised.

A Step Toward Global Respiratory Leadership

Glenmark has been steadily positioning itself as a dominant force in respiratory medicine. With operations in more than 80 countries, 11 state-of-the-art manufacturing facilities across four continents, and a research legacy reinforced by recognition from In Vivo/Scrip 100 and Generics Bulletin rankings, the company continues to push boundaries in pharmaceutical innovation.

Its commitment to sustainable operations is also noteworthy: Glenmark’s Greenhouse Gas (GHG) reduction targets were validated by the Science Based Targets initiative (SBTi) in 2023, making it only the second Indian pharmaceutical company to earn this distinction.

Impact on COPD Care and Global Healthcare Landscape

COPD affects millions worldwide and is one of the leading causes of death. Treatment advancement has historically been incremental, focusing on improved inhalers, better combination medications, and patient education.

Glenmark’s newly launched therapy could significantly reshape the global COPD treatment paradigm by:

1. Simplifying Therapy

Patients no longer require multiple devices or inhalation steps.

2. Reducing Medication Errors

Nebulized delivery eliminates coordination challenges and maximizes therapeutic absorption.

3. Increasing Accessibility

Especially beneficial for elderly patients, those in advanced disease stages, and individuals with limited dexterity.

4. Introducing a New Global Standard

Being the first of its kind, this therapy may encourage global pharmaceutical companies and regulators to re-evaluate the role of nebulized triple therapies in COPD guidelines.

5. Supporting Better Long-Term Outcomes

Improved adherence generally leads to fewer exacerbations, reduced hospitalizations, and improved quality of life.

Future Potential and Industry Implications

The launch sets new benchmarks not just in India but globally. It is expected to:

  • Influence treatment protocols for moderate to severe COPD cases.

  • Potentially open pathways for similar innovations in asthma and other chronic respiratory disorders.

  • Accelerate R&D investments in nebulized combination therapies globally.

  • Strengthen India’s position as a hub for pharmaceutical innovation.

With COPD cases rising worldwide due to pollution, smoking, occupational hazards, and aging populations, the need for accessible, patient-friendly solutions has never been greater. Glenmark’s innovation arrives at a crucial time, offering a significant leap forward.

About Glenmark Pharmaceuticals

Glenmark is globally recognized for its therapeutic competency in respiratory, dermatology, and oncology. With diversified business verticals covering branded formulations, generics, and OTC products, the company continues to remain one of the most influential global pharma players originating from India.

Beyond business, Glenmark has also impacted over 3 million lives through CSR initiatives in the last decade, reaffirming its commitment to societal well-being.


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