In a groundbreaking development for sustainable respiratory care, AstraZeneca’s Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF) has been approved for use in the United Kingdom with a next-generation propellant featuring near-zero Global Warming Potential (GWP). This marks the first regulatory approval globally of an inhaled respiratory medicine using a climate-conscious pressurised metered-dose inhaler (pMDI) formulation.

Already licensed for the treatment of chronic obstructive pulmonary disease (COPD) in adults, the new Trixeo formulation represents a major step forward in green pharmaceutical innovation, aligning clinical efficacy with climate responsibility.

A First-of-Its-Kind pMDI Approval

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) granted the approval based on AstraZeneca’s clinical development programme using HFO-1234ze(E)—a next-generation propellant with 99.9% lower GWP than the traditional hydrofluoroalkane (HFA-134a) used in current pMDIs. The approved formulation demonstrates bioequivalence to the previous version and retains the same safety and tolerability profile.

“The UK approval of Trixeo with this revolutionary propellant is an industry first,” said Ruud Dobber, Executive Vice President of AstraZeneca’s Biopharmaceuticals Business Unit. “It is a significant milestone in our Ambition Zero Carbon strategy, allowing us to address the needs of both patients and the environment.”

Environmental and Clinical Balance

Trixeo Aerosphere is a fixed-dose triple-combination therapy, marketed as Breztri Aerosphere in the US, China, and Japan. It includes:

• Budesonide (inhaled corticosteroid - ICS)

• Glycopyrronium (long-acting muscarinic antagonist - LAMA)

• Formoterol fumarate (long-acting beta-agonist - LABA)

Delivered via the Aerosphere pMDI, this triple therapy plays a pivotal role in the management of moderate-to-severe COPD. The reformulated version, now with a near-zero GWP, ensures continuity in clinical efficacy, dosage regimen, and indications, while greatly reducing environmental impact.

In the UK alone, 70% of all inhaled medications are administered via pMDIs, contributing around 3% of the total NHS carbon footprint. Globally, pMDIs account for 78% of inhaler usage and contribute 0.04% of global GHG emissions.

“This transition allows healthcare professionals to make decisions based on patient need, not environmental compromise,” noted Professor Omar Usmani of Imperial College London. “It’s a meaningful advancement in responsible prescribing.”

Collaboration for Green Innovation

The environmentally friendly propellant, HFO-1234ze(E), was developed by Honeywell in collaboration with AstraZeneca. It is designed to deliver near-zero climate impact without sacrificing drug delivery efficiency or patient safety.

The approval is part of a broader shift within AstraZeneca to transition its entire pMDI portfolio to next-generation propellants by 2030, a central component of its Ambition Zero Carbon strategy. This strategy includes:

• A 98% reduction in operational GHG emissions by 2026 (vs. 2015 baseline)

• A 50% cut in value chain emissions by 2030

• Achieving carbon negativity for residual emissions by 2030

• A 90% total emissions reduction by 2045

AstraZeneca was among the first seven companies worldwide to have its net zero goals validated by the Science-Based Targets initiative (SBTi).

A Global Outlook for Approval

Beyond the UK, regulatory submissions for Trixeo/Breztri with the new propellant are under review in Europe, China, and other global markets. Clinical studies are also underway for the bioequivalence of HFO-1234ze(E) with other pMDI-based AstraZeneca therapies.

The company’s Respiratory & Immunology division remains a critical growth driver and innovation hub, with a strong legacy in respiratory care spanning over five decades. Its vision includes:

• Eliminating COPD as a top global killer

• Eliminating asthma attacks

• Achieving remission in immune-mediated diseases

Looking Ahead

The transition of Trixeo to a low-carbon alternative marks a significant stride toward sustainable healthcare, proving that clinical performance and climate action can coexist. As the NHS and healthcare systems globally seek to reduce their environmental footprints, AstraZeneca’s innovation stands as a template for eco-conscious drug development.

The roll-out of the new Trixeo Aerosphere in the UK will begin in the coming months, with broader international availability anticipated following regulatory approvals.

Fast Facts: Trixeo with Near-Zero GWP Propellant

• Brand names: Trixeo (EU/UK), Breztri (US, China, Japan)

• Indication: COPD maintenance therapy

• Propellant: HFO-1234ze(E) by Honeywell

• Reduction in GWP: 99.9% vs. HFA-134a

• Environmental impact: On par with dry-powder inhalers (DPIs)

• Global presence: Approved in over 80 countries, >5 million patients treated

• Next steps: Global regulatory submissions ongoing