Chiesi, the international research-focused biopharmaceutical company and certified B Corp, has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Clenil Modulite (beclometasone 100 mcg and 200 mcg) formulated with a next-generation, non-PFAS, low global warming potential (GWP) propellant.

The approval marks a global first, making the UK the first country to authorise pressurised metered-dose inhalers (pMDIs) using the innovative low-carbon propellant technology. The development represents a milestone in advancing sustainable respiratory care while ensuring continuity of treatment for patients.

Pressurised metered-dose inhalers remain the most commonly prescribed inhaler type in the UK, accounting for approximately 70 percent of the 60 million inhalers prescribed annually. According to Chiesi, transitioning Clenil Modulite to the new propellant is expected to reduce the product's carbon footprint by up to 90 percent compared to inhalers using the conventional HFA-134a propellant, without altering the device or compromising patient choice.

The MHRA approval was supported by pharmacokinetic and safety studies demonstrating that the new formulation using HFA-152a delivers therapeutic equivalence and comparable tolerability to the existing formulation based on HFA-134a.

Commenting on the approval, Professor Dave Singh, Professor of Clinical Pharmacology and Respiratory Medicine at the University of Manchester, said the milestone represents a major advancement in sustainable respiratory medicine. He noted that clinical studies have confirmed equivalent therapeutic performance, allowing patients to continue using the treatment they rely on while significantly reducing the environmental impact associated with inhaler propellants.

The low-GWP propellant used in the newly approved inhalers is manufactured by Orbia Fluor and Energy Materials, whose UK operations are based in Runcorn.

Ralph Blom, General Manager of Chiesi UK and Ireland, said the approval marks the first step in transitioning the company's pMDI portfolio to environmentally sustainable propellants. He added that the initiative aligns with Chiesi's broader strategy to reduce emissions, support the UK's National Health Service (NHS) decarbonisation goals, and preserve patient access to familiar treatment options.

The propellant transition forms a central part of Chiesi's Net Zero roadmap, as inhaler propellants currently account for the largest share of the company's greenhouse gas emissions. Chiesi has committed to achieving Net Zero greenhouse gas emissions across its entire value chain by 2035, significantly ahead of both the European Union's climate neutrality target and the NHS's Net Zero ambition. The company's climate targets were validated by the Science Based Targets initiative (SBTi) in 2024.

As a research-driven global biopharmaceutical company, Chiesi develops therapies across respiratory health, rare diseases and specialty care. The latest approval reinforces the company's commitment to combining pharmaceutical innovation with environmental sustainability, offering respiratory treatments that benefit both patients and the planet.