Key highlights:

• Successfully completed the TRECOS Phase III study*, supporting the long-term safety of Chiesi’s carbon minimal pressurized metered dose inhaler (pMDI) platform¹
• Aiming to become the first pharmaceutical company to transition its broad pMDI portfolio to a next generation propellant, significantly reducing lifecycle carbon footprint²
• Advancing the Group’s plans to deliver on its Net Zero commitment across the full product portfolio and value chain by 2035†²
• Delivering sustainable respiratory care without compromise—maintaining clinical choice and continuity for patients as we reduce the environmental footprint of our inhaler portfolio

Parma, Italy, 26 September 2025 – Chiesi Group, an international research-focused biopharmaceutical company, today announced the completion of its Phase III TRECOS study, a key milestone in the development of its carbon minimal pMDI portfolio¹. The study evaluated the long-term safety and tolerability of HFA-152a, a next-generation propellant with significantly lower global warming potential (GWP). This marks an important step in Chiesi’s commitment to delivering sustainable respiratory care in line with its ambition to become the first pharmaceutical company to reach Net Zero across its full value chain by 2035².

“Completing the TRECOS study marks an important milestone in our efforts to advance more sustainable respiratory care” said Michelle Soriano, Executive Vice President Air Franchise. “This achievement reflects our determination to align innovation with environmental responsibility. We believe that by delivering sustainable change while retaining a broad portfolio of pMDIs we can lead the way. We are changing, so patients don’t have to“.

Redesigning Respiratory Care for a Net Zero Future

Chiesi’s carbon minimal inhaler program forms part of a broader ambition to achieve Net Zero greenhouse gases emissions by 2035, making Chiesi the first pharmaceutical company globally to adopt such a target across its full value chain². Central to this journey is the transition to the next generation propellant HFA-152a, which tackles the largest single source of Chiesi’s greenhouse gas emissions and represents one of the most impactful actions in its Net Zero roadmap.

Building on this, the TRECOS Phase III long term safety study adds to a comprehensive preclinical and clinical program indicating that the formulations containing HFA-152a perform comparably versus current ones, while enabling up to 90% lower carbon footprint versus today’s products³. Together with Chiesi’s dry powder inhaler (DPI) options, this portfolio of pMDIs with next-generation propellant are designed to support a seamless transition to carbon-minimal respiratory care, so patients and clinicians can continue with the most appropriate therapies and devices.

As part of its long-term sustainability and development strategy, Chiesi intentionally selected HFA-152a as the next-generation propellant for its carbon minimal inhalers. The choice, made in 2018, was based not only on the low GWP, but as well on the availability of a robust safety and non-toxicity data package⁴.

“The completion of our clinical development program with the TRECOS Phase III study paves the way for regulatory submissions,” said Diego Ardigò, Global Head of Research & Development. “Across the program, the formulation containing the next-generation propellant HFA-152a has demonstrated a reassuring safety and performance profile. If approved, this innovation could help patients and clinicians maintain familiar inhaler options with a lower climate impact.”

Chiesi at ERS 2025: The Role of Next-Generation Propellants in Reducing Environmental Impact

Chiesi will further explore the future of sustainable respiratory care at the European Respiratory Society Congress (ERS) 2025 in Amsterdam where it will contribute to scientific discussions on patient-centered treatment and environmental innovation.

As part of the program, Chiesi will sponsor a scientific symposium on Sunday, 28 September, from 17:30 to 19:00 CET, focusing on personalized respiratory care, examining the clinical and sustainability considerations linked to device selection and the importance of maintaining options and clinical choice in treatment. The session will also include insights into the development of carbon minimal pMDIs and the role of next-generation propellants in reducing the carbon footprint of the healthcare sector.

*About the TRECOS Study

The TRECOS study was a large-scale, global Phase III clinical trial led by Chiesi to evaluate the long-term safety and tolerability of its next-generation, carbon-minimal inhaler platform. Enrolling over 820 adult asthma patients across more than 140 sites in 15 countries, the study compared two versions of the combination inhaler CHF5993—one using HFA-134a, a traditional propellant with a GWP of 1,430, and the other using HFA-152a, a breakthrough alternative with a GWP of just 124.

The aim of the study was to determine whether the HFA-152a-based inhaler is clinically safe in treating asthma, while also offering a substantial reduction in greenhouse gas emissions¹. In addition to clinical outcomes, the study also contributed to a broader understanding of the environmental implications of inhaler propellants, supporting Chiesi’s efforts to align respiratory care with its 2035 Net Zero target.

Some of the clinical pharmacology studies have already been presented and/or published^5-7.

Results from the study will be shared with regulatory authorities, with first submissions expected in the coming months and further details to be shared at upcoming scientific congresses.

†Net Zero Commitment

Chiesi plans to be the first pharmaceutical company to achieve Net Zero greenhouse gas emissions across its entire value chain by 2035, 15 years ahead of the European Climate Neutrality target. This commitment covers all emission scopes.Chiesi’s targets were validated by the Science Based Targets initiative (SBTi) in April 2024. The Group has consolidated its greenhouse gas inventory in line with ISO 14064 and the GHG Protocol standards, with annual audits carried out by independent third parties.

The transition to the next-generation propellant HFA-152a is one of the most impactful actions in Chiesi’s Net Zero roadmap, as inhaler propellants represent the single largest source of the Group’s greenhouse gas emissions.

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About Chiesi Group  

Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment. 

By adopting the legal form of Benefit Corporation in Italy, the US, France and Colombia, Chiesi’s commitment to creating shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, Chiesi is part of a global community of businesses that meet high standards of social and environmental impact. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035. 

With 90 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,500 employees. The Group’s research and development center in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden. 

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Press info: 

Vera Valota 

Head of Global Communications, AIR & CARE 

Tel: +44 734 188 99 92 

Email: v.valota@chiesi.com  

References

1. NCT06264674 - Comparison Between CHF5993 pMDI 200/6/5 µg HFA-152a VS CHF5993 pMDI 200/6/12.5 µg HFA-134a in Subjects With Asthma (TRECOS). https://clinicaltrials.gov/study/NCT06264674
2. Chiesi Sustainability Report 2024. https://www.chiesi.com/en/about-us/annual-report-and-csr/
3. Panigone S. et al 2020, BMJ Open Respiratory Research: Environmental impact of inhalers for respiratory diseases: decreasing the carbon footprint while preserving patient-tailored treatment. https://doi.org/10.1136/bmjresp-2020-000571
4. Orbia Fluor & Energy Materials - Zephex® 152a. https://www.kouraglobal.com/applications/medical-propellants/zephex-152a/
5. Rony F. et al 2024, Pulmonary Pharmacology & Therapeutics: Evaluating the pharmacokinetics of beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide delivered via pressurized metered-dose inhaler using a low global warming potential propellant. https://doi.org/10.1016/j.pupt.2024.102299
6. Rony F. et al 2025, Pulmonary Pharmacology & Therapeutics: Impact on beclometasone dipropionate pharmacokinetics when switching to a low global warming potential propellant in a pressurized metered-dose inhaler. https://doi.org/10.1016/j.pupt.2025.102356
7. Salvadori M. et al 2025, Pulmonary Pharmacology & Therapeutics: The low global warming potential propellant HFA-152a does not induce bronchoconstriction or impair mucociliary clearance. https://doi.org/10.1016/j.pupt.2025.102358