The MHRA has approved the world’s first lower-carbon Clenil Modulite beclometasone inhalers using HFA-152a propellant for adults and children with asthma, with UK launch expected later in 2026.
Written By: Kirti Kumbhar, M. Pharm (QA)
Reviewed By: Pharmacally Editorial Team
The UK’s Medicines and Healthcare products Regulatory Agency has approved the world’s first pressurised metered-dose inhalers (pMDIs) that use the next-generation propellant HFA-152a, marking a significant step toward reducing the environmental impact of inhaled medicines without changing established asthma treatment. The approval covers new versions of Clenil Modulite 100 micrograms and Clenil Modulite 200 micrograms inhalers, marketed by Chiesi Limited, for the maintenance treatment of asthma in adults and children.
The authorization, granted on 21 July 2026, applies to reformulated versions of the widely used beclometasone dipropionate inhalers. The new products are expected to become available in the UK later this year, while existing Clenil Modulite inhalers will remain available during the transition.
First Approval for HFA-152a Propellant
The newly approved inhalers contain the same active ingredient, beclometasone dipropionate, an inhaled corticosteroid that reduces airway inflammation and helps prevent asthma symptoms and exacerbations. The innovation lies in the replacement of the traditional propellant with HFA-152a, a next-generation propellant developed to lower the carbon footprint of pMDIs.
The propellant itself has no therapeutic activity. Instead, it delivers the medication from the inhaler into the lungs. According to the MHRA, the reformulated products provide comparable performance to the currently authorized inhalers while maintaining the same quality, safety, and clinical effectiveness.
The approval does not change the approved indications, dosing recommendations, or clinical use of Clenil Modulite.
Asthma Remains a Major Public Health Challenge
Asthma is a chronic inflammatory disease of the airways affecting millions of people worldwide. Patients commonly experience wheezing, coughing, chest tightness, and shortness of breath, with inhaled corticosteroids remaining the cornerstone of long-term disease control.
Beclometasone dipropionate suppresses airway inflammation, reducing the frequency and severity of asthma symptoms and helping prevent exacerbations when used regularly as maintenance therapy.
The availability of lower-carbon inhalers reflects growing efforts to reduce healthcare-related greenhouse gas emissions while preserving effective patient care.
Regulatory Evidence Supports Comparable Clinical Performance
The MHRA approved the reformulated inhalers through a variation to the existing marketing authorization after reviewing evidence demonstrating that the new HFA-152a formulations perform comparably to the currently marketed products.
Regulators concluded that the inhalers maintain the established quality, safety, and clinical benefit of Clenil Modulite despite the change in propellant. Because the active pharmaceutical ingredient remains unchanged, patients are expected to receive the same therapeutic benefit from the new products.
The agency noted that the updated Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) will be published once the products become commercially available.
MHRA Highlights Innovation and Sustainability
Julian Beach, Executive Director of Healthcare Quality and Access at the MHRA, said the approval demonstrates that innovation can improve environmental sustainability while maintaining the high standards of quality, safety, and effectiveness expected for medicines.
He emphasized that asthma inhalers remain essential for millions of patients and confirmed that the agency will continue to monitor the safety and effectiveness of the reformulated products through routine pharmacovigilance.
Safety Profile Remains Unchanged
The safety profile of the new inhalers is expected to remain consistent with currently available beclometasone products. Common adverse effects include oral thrush, hoarseness, and throat irritation, which are well recognized with inhaled corticosteroid therapy.
Healthcare professionals and patients are encouraged to report suspected adverse reactions through the MHRA’s Yellow Card Scheme as part of ongoing post-marketing safety surveillance.
Commercial Launch Planned Later This Year
The marketing authorization variation was granted to Chiesi Limited on 21 July 2026, with commercial availability expected later in 2026 across the UK. Existing Clenil Modulite inhalers will remain available until the new lower-carbon versions enter routine clinical use.
The approval establishes the first global regulatory authorization for an HFA-152a-powered pMDI and may provide a pathway for broader adoption of lower-emission inhaler technologies as healthcare systems work to reduce their environmental footprint while maintaining effective asthma management.
Reference
MHRA approves world’s first lower-carbon beclometasone inhalers for patients with asthma – GOV.UK
About the Writer
Kirti Kumbhar (LinkedIn) is an M.Pharm graduate with experience in Quality Assurance at Lupin Limited and a strong interest in clinical research, regulatory affairs, and Trial Master File (TMF) management. She has developed knowledge of regulatory documentation, quality systems, compliance, and healthcare research through her professional experience. Passionate about clinical development and continuous learning, Kirti is committed to supporting high-quality healthcare documentation, regulatory excellence, and research-driven healthcare advancements.