US FDA approves BREZTRI AEROSPHERE with a new propellant that has near-zero global warming potential

New propellant offers 99.9% reduction in global warming potential* compared to the current propellant. 

AstraZeneca’s fixed-dosed triple-combination therapy for asthma and COPD, was the Company’s
first medicine to transition to the new propellant in the UK and EU.

AstraZeneca’s BREZTRI AEROSPHERE® (budesonide/glycopyrrolate/formoterol fumarate), already approved for the treatment of chronic obstructive pulmonary disease (COPD) in adults and asthma in patients 12 years of age and older, has now been approved by the US Food and Drug Administration (FDA) with a new propellant with near-zero global warming potential (GWP). This is the first medicine delivered by a pressurized metered-dose inhaler (pMDI) approved with a lower-carbon-footprint propellant, comparable to inhaled medicines that do not require a propellant.1 

The FDA approval was based on results from the clinical development program, which demonstrated bioequivalence between BREZTRI AEROSPHERE formulated with the new propellant, and BREZTRI AEROSPHERE with the current propellant. The safety and tolerability profile for BREZTRI AEROSPHERE with the new propellant was consistent with the known profile of the medicine.2

Nicole Chase, MD, FACAAI, FAAP, Associate Professor of Medicine at the University of Minnesota and Partner at St. Paul Allergy & Asthma, said: “Inhaled medicines delivered by pMDIs are essential for millions of people living with respiratory diseases in the US. The upcoming transition of BREZTRI AEROSPHERE to the propellant with near-zero global warming potential means that healthcare professionals can prioritize patient outcomes based on clinical need, while also reducing the carbon footprint of care.”

James Teague, Vice President, US Respiratory & Immunology, AstraZeneca, said: “The transition of BREZTRI AEROSPHERE to the new propellant allows us to care for patients, society, and the planet, and is a significant milestone in our commitment to delivering innovations for sustainable healthcare in the US. Starting with BREZTRI AEROSPHERE, the transition to the near-zero global warming potential propellant across our pressurized metered-dose inhaled respiratory medicines is an important part of our Ambition Zero Carbon strategy.”

BREZTRI AEROSPHERE was the first medicine in AstraZeneca’s portfolio of pMDIs to transition to the new propellant in the UK and the transition has been completed in 27 countries across the EU. AstraZeneca aims to transition its wider pMDI portfolio to the near-zero GWP propellant by 2030 as part of the Company’s Ambition Zero Carbon strategy.3 Information on the transition and availability of BREZTRI AEROSPHERE formulated with the new propellant in the US will be made available at a later date.

*Based on the 100-year global warming potential values of the new propellant vs the current propellant; the claim relates to the propellant only, which represents 95%–98% of the overall global warming effect.

IMPORTANT SAFETY INFORMATION

  • BREZTRI combines 3 medicines, an inhaled corticosteroid (ICS) medicine (budesonide), an anticholinergic medicine (glycopyrrolate), and a long-acting beta2-adrenergic agonist (LABA) medicine (formoterol fumarate). LABA medicines, such as formoterol fumarate, when used alone can increase the risk of hospitalizations and death from asthma problems. When an ICS and LABA are used together, this risk is not significantly increased
  • Do not use BREZTRI to treat sudden severe symptoms of COPD or asthma, or if you are allergic to budesonide, glycopyrrolate, formoterol fumarate, or any of the ingredients in BREZTRI
  • Do not take BREZTRI with other medicines that contain a long-acting beta2-adrenergic agonist (LABA) or an anticholinergic for any reason. Tell your healthcare provider about all your medical conditions and about all the medicines you take
  • Do not use BREZTRI more than prescribed
  • Do not use in children younger than 12 years of age
  • Call your healthcare provider or get medical care right away if your breathing problems get worse, if you need to use your rescue inhaler more often than usual, or your rescue inhaler does not work as well to relieve your symptoms
  • BREZTRI can cause serious side effects, including:
    • Fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using BREZTRI to help reduce your chance of getting thrush
    • Pneumonia. People with COPD have a higher chance of getting pneumonia. Call your healthcare provider if you notice an increase in mucus (sputum) production or change in mucus color, fever, chills, increased cough, or increased breathing problems
    • Weakened immune system and increased chance of getting infections (immunosuppression)
    • Reduced adrenal function (adrenal insufficiency). This can happen when you stop taking oral corticosteroid medicines and start inhaled corticosteroid medicine
    • Sudden breathing problems immediately after inhaling BREZTRI. If this happens, stop taking BREZTRI and call your healthcare provider right away
    • Serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms: rash; hives; swelling of your face, mouth, and tongue; or breathing problems
    • Effects on your heart such as increased blood pressure, a fast or irregular heartbeat, or chest pain
    • Effects on your nervous system such as tremor or nervousness
    • Bone thinning or weakness (osteoporosis)
    • Slowed growth in children. A child’s growth should be checked regularly while using BREZTRI
    • Acute narrow-angle glaucoma and cataracts. If you have new or worsening eye or vision problems, call your healthcare provider right away before taking another dose
    • Urinary retention. If you have new or worsening symptoms or difficulty urinating, stop taking BREZTRI and call your healthcare provider right away before taking another dose
    • Changes in laboratory blood values, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia). Low levels of potassium may cause symptoms of muscle spasm, muscle weakness, or abnormal heart rhythm
  • Most common side effects include: upper respiratory tract infection, pneumonia, back pain, thrush in your mouth and throat, joint pain, flu, headache, high blood sugar levels, muscle spasms, cough, inflammation of the sinuses, diarrhea, hoarseness, urinary tract infection, nausea, difficulty sleeping, feeling anxious and heart palpitations

APPROVED USE

BREZTRI AEROSPHERE 160/9/4.8 mcg is used long term to treat chronic obstructive pulmonary disease (COPD) in adults, including chronic bronchitis, emphysema, or both, for better breathing and fewer flare-ups.

BREZTRI AEROSPHERE 160/18/4.8 mcg is used for the treatment of asthma in patients 12 years of age and older.

BREZTRI is not used to relieve sudden breathing problems and will not replace a rescue inhaler.

Please see full Prescribing Information, including Patient Information and Instructions for Use, and discuss with your doctor.

You may report side effects related to AstraZeneca products (Opens new window).

Notes

AstraZeneca’s new propellant clinical development program
AstraZeneca has conducted clinical trials to assess the efficacy and safety of the new propellant with near-zero global warming potential, with the AstraZeneca portfolio of inhaled medicines delivered by pressurized metered-dose inhalers (pMDIs).

The first medicine to be assessed in the program was BREZTRI AEROSPHERE (budesonide/glycopyrrolate/formoterol fumarate) through in vitro, in vivo bioequivalence (PK), safety and efficacy clinical studies.4-9 The program established bioequivalence between BREZTRI AEROSPHERE with the new propellant, and BREZTRI AEROSPHERE with the current propellant. The safety and tolerability profile for BREZTRI AEROSPHERE with the new propellant was consistent with the known profile of the medicine.2

BREZTRI AEROSPHERE

Budesonide/glycopyrronium/formoterol fumarate or budesonide/glycopyrrolate/formoterol fumarate, approved under the brand name BREZTRI AEROSPHERE in Japan, China and the US, and TRIXEO AEROSPHERE in the EU, is a single-inhaler, fixed-dose triple-combination of formoterol fumarate, a long-acting beta2-agonist (LABA); glycopyrronium bromide, a long-acting muscarinic antagonist (LAMA); with budesonide, an ICS, and delivered via the AEROSPHERE pMDI. BREZTRI/TRIXEO is approved in the US, Europe and Japan to treat asthma in patients 12 years of age and older. Regulatory filings for BREZTRI/TRIXEO in asthma are currently under review in all other major regions. BREZTRI/TRIXEO is also approved to treat adults with COPD in 90 countries worldwide including the US, EU, China, Japan, and was prescribed to more than 6.8 million patients globally in 2025.10

AstraZeneca’s Collaboration With Solstice
Developed by Solstice, the medical-grade version of the new propellant is critical to enable the transition of pMDI medicines with reduced climate impact, given its near-zero GWP. AstraZeneca announced in 2022 its collaboration with Solstice to develop respiratory inhaled medicines using the new propellant.

Ambition Zero Carbon
Through its Ambition Zero Carbon strategy, AstraZeneca is investing more than $1 billion to decarbonize its operations and value chain and achieve science-based net zero by 2045. The Company is progressing toward its target to reduce greenhouse gas (GHG) emissions from its global operations and fleet (Scope 1 and 2) by 98% by the end of 2026, compared to a 2015 baseline. AstraZeneca also aims to reduce its value chain emissions (Scope 3) by 35% by 2030, compared to a 2019 baseline. AstraZeneca was one of the first seven companies globally to have its net zero targets verified by the Science-Based Targets initiative (SBTi) Corporate Net-Zero Standard.

AstraZeneca in Respiratory & Immunology

Respiratory & Immunology, part of AstraZeneca BioPharmaceuticals, is a key disease area and growth driver to the Company.

AstraZeneca is an established leader in respiratory care with a 50-year heritage and a growing portfolio of medicines in immune-mediated diseases. The Company is committed to addressing the vast unmet needs of these chronic, often debilitating, diseases with a pipeline and portfolio of inhaled medicines, biologics and new modalities aimed at previously unreachable biologic targets. Our ambition is to deliver life-changing medicines that help eliminate COPD as a leading cause of death, eliminate asthma attacks and achieve clinical remission in immune-mediated diseases.

AstraZeneca

AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Social Media @AstraZeneca.

Media Inquiries

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References

1. Data on File. REF-140251. AstraZeneca Pharmaceuticals LP.

2. Bednarczyk, et al. Bioequivalence of budesonide/glycopyrrolate/formoterol fumarate with a next-generation propellant versus hydrofluoroalkane-134a in healthy adults: phase I, randomized, double-blind, single-dose, partial-replicate, three-way cross-over lung exposure and total systemic exposure studies. Ther Adv Respir Dis. 2026;20:1-15.

3. AstraZeneca. Our Sustainability Impact. Accessed October 8, 2026. https://www.astrazeneca.com/sustainability/resources/pdf.html?pdfPath=https://www.astrazeneca.com/content/dam/az/Sustainability/2026/pdf/AZ-Sustainability-Impact-Publication-2026.pdf.  

4. ClinicalTrials.gov. NCT05569421. 

5. ClinicalTrials.gov. NCT05477108. 

6. ClinicalTrials.gov. NCT06297668. 

7. ClinicalTrials.gov. NCT05755932. 

8. ClinicalTrials.gov. NCT05850494. 

9. ClinicalTrials.gov. NCT06075095. 

10. Data on File. REF-325003. AstraZeneca Pharmaceuticals LP.