GR agonists(Glucocorticoid receptor agonists), mAChRs antagonists(Muscarinic acetylcholine receptor antagonists), β2-adrenergic receptor agonists(Beta-2 adrenergic receptor agonists)

Therapeutic Areas

Infectious DiseasesRespiratory DiseasesImmune System Diseases

Active Indication

AsthmaBronchitis, ChronicPulmonary Disease, Chronic Obstructive+ [4]

Inactive Indication-

Originator Organization

AstraZeneca PLC

Active Organization

AstraZeneca PLC

AstraZeneca Investment (China) Co. Ltd.

Pearl Therapeutics, Inc.

+ [6]

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

Japan (18 Jun 2019),

Bronchitis, ChronicPulmonary Disease, Chronic ObstructivePulmonary Emphysema

Regulation-

Structure/Sequence

Molecular FormulaC25H34O6

InChIKeyVOVIALXJUBGFJZ-KWVAZRHASA-N

CAS Registry51333-22-3

View All Structures (3)

Clinical Trials associated with Budesonide/Formoterol fumarate/Glycopyrronium Bromide

NCT07595796

/ Not yet recruitingNot ApplicableIIT

Efficacy Evaluation of Budesonide/Glycopyrronium Bromide/Formoterol Inhalation Aerosol in Symptomatic Preserved Ratio Impaired Spirometry (PRISm): A Single-arm Multicenter Clinical Trial

Preserved Ratio Impaired Spirometry (PRISm) is characterized by a normal forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio but an FEV1 below 80% of the predicted value. It has a population prevalence of approximately 10% and is associated with marked symptoms, a high risk of acute exacerbations, and increased mortality. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) defines PRISm as a pre-chronic obstructive pulmonary disease (COPD) state, and 20%-30% of patients with PRISm will progress to COPD. Currently, no evidence-based therapy exists for PRISm; management is mainly symptomatic relief, and there is an urgent need for evidence-based support. This single-arm clinical trial preliminarily evaluates the efficacy and safety of budesonide/glycopyrronium/formoterol inhalation aerosol in symptomatic patients with PRISm. Symptomatic smokers who meet the diagnostic criteria for PRISm and have an FEV1/FVC ratio ≥0.7 and <0.8 are enrolled and treated with budesonide/glycopyrronium/formoterol inhalation therapy for 12 weeks. The primary endpoint is the change from baseline in FEV1; secondary endpoints include symptom score (COPD Assessment Test, CAT) and quality of life (St George's Respiratory Questionnaire, SGRQ); safety is assessed by recording adverse events (e.g., cardiovascular events); and exploratory analyses examine the association between biomarkers (e.g., peripheral blood eosinophil count, serum IgE level) and treatment efficacy. The study aims to preliminarily explore the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler therapy for PRISm. Early intervention may delay the progression from PRISm to COPD, reduce the burden of chronic respiratory disease, and have important clinical translational value and public health significance.

Start Date01 Jun 2026

Sponsor / Collaborator

Sun Yat-Sen Memorial Hospital

NCT06531798

/ RecruitingPhase 4

Post-marketing Phase IV, Multicenter, Prospective Study to Observe the Safety and Tolerability of Breztri aerosphereTM Containing a Fixed Dose Combination of Budesonide 160 mcg/ Glycopyrronium 7.2 mcg/ Formoterol Fumarate Dehydrate 5 mcg in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

The purpose of this study is to observe the safety and tolerability of Breztri aerosphereTM as maintenance treatment in Indian patients with moderate to severe COPD.

Start Date30 Jan 2026

Sponsor / Collaborator

AstraZeneca PLC

CTRI/2025/12/099667

/ Active, not recruitingPhase 4

A Phase IV study to evaluate safety and efficacy of Glycopyrronium/Formoterol/Budesonide (12.5mcg/6mcg/200mcg) triple therapy delivered through pressurized metered dose inhaler [pMDI] in patients with Chronic Obstructive Pulmonary Disease (COPD). - None

Start Date22 Jan 2026

Sponsor / Collaborator

Cipla Ltd.

100 Clinical Results associated with Budesonide/Formoterol fumarate/Glycopyrronium Bromide

100 Translational Medicine associated with Budesonide/Formoterol fumarate/Glycopyrronium Bromide

100 Patents (Medical) associated with Budesonide/Formoterol fumarate/Glycopyrronium Bromide

Literatures (Medical) associated with Budesonide/Formoterol fumarate/Glycopyrronium Bromide

01 Oct 2026·EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Airway deposition of two fixed-dose triple combination pMDI drugs at different inhalation flow rates and insertion angles

Article

Author: Nagy, Etelka ; Horváth, Alpár ; Keglevich, András ; Farkas, Árpád ; Nagy, Attila ; Kovács, Tamás ; Sánta, Balázs

The objective of this study was to establish a robust experimental and computational framework for characterizing pressurized metered-dose inhaler (pMDI) plumes and quantifying regional deposition fractions of two triple-combination aerosol drugs, Trimbow® (BDP/GLY/FF) and Trixeo Aerosphere® (BUD/GLY/FF). Specifically, we investigated the influence of inhalation flow rate and inhaler insertion angle on whole-airway and regional drug deposition. To achieve this, laser-based measurement techniques were developed and coupled with advanced image-processing algorithms. Computational fluid and particle dynamics simulations, combined with analytical particle-tracking methods, were employed to model the fate of aerosol particles from inhalation to deposition or exhalation. Results demonstrated efficient lung deposition for both drugs across a wide range of inhalation flow rates. For BDP/GLY/FF, total lung deposition accounted for 32.1%, 39.8%, 41.2%, and 36.1% of the emitted dose at flow rates of 30, 60, 90, and 120 L/min, respectively. Corresponding deposition fractions for BUD/GLY/FF were 31.9%, 43.0%, 44.0%, and 38.9%. Regional analysis revealed that BDP/GLY/FF exhibited comparable deposition in the first eight bronchial generations (large bronchi) and in the distal airways. In contrast, BUD/GLY/FF showed higher deposition (4 to 6 times greater) in the large bronchi compared to deeper regions. Furthermore, inhaler orientation significantly affected deposition outcomes. A slightly upward mouthpiece insertion enhanced lung deposition, whereas a downward orientation reduced it compared to horizontal positioning. These findings underscore the importance of inhalation technique and device orientation in optimizing therapeutic efficacy of pMDI-delivered triple-combination drugs.

01 Sep 2026·Pakistan Journal of Pharmaceutical Sciences

Clinical pharmacist-led intervention improves anxiety, depression and inhaler technique in budesonide/glycopyrronium/formoterol-using patients: A single-center prospective randomized cohort study.

Article

Author: Lin, Meiying ; Chen, Youwei ; Chen, Zhibin ; Zou, Qifeng ; Wang, Zhiyong

BACKGROUND:

Chronic respiratory disease (CRD) patients using budesonide/glycopyrronium/formoterol (BGF) inhalers often face anxiety, depression and incorrect inhaler technique, which impair treatment outcomes.

OBJECTIVES:

This study aimed to evaluate the effects of clinical pharmacist-led intervention on anxiety, depression, inhaler technique, adverse drug reactions (ADR) and body mass index (BMI) in BGF users.

METHODS:

A prospective randomized cohort study enrolled 100 BGF users from July 2023 to December 2023 at a public tertiary hospital and randomized them 1:1 to either the experimental or control group. Among these, 48 experimental patients and 45 control patients completed this study, which comprised an initial and three follow-up visits. The control group received routine care, whereas the experimental group received supplementary care led by a clinical pharmacist alongside conventional treatment. Outcomes included Self-Rating Anxiety Scale (SAS), the Self-Rating Depression Scale (SDS), Inhaler technique scores, Adverse drug reaction (ADR) and Body mass index (BMI) were assessed at 1-, 3- and 6-months post-intervention.

RESULTS:

The experimental group had lower SAS scores at 3/6 months (p<0.05), lower moderate-to-severe anxiety rate at 6 months (68.75% vs. 93.33%, p<0.05) and lower SDS scores at 3/6 months (p<0.05). Inhaler technique scores were higher in the experimental group at all follow-ups (p<0.05). ADR incidence was lower (2 vs. 5 cases) and BMI slightly increased (p=0.312).

CONCLUSIONS:

Pharmacist-led intervention alleviates anxiety/depression, improves inhaler technique and reduces ADR in BGF users. These findings support the adoption of pharmacist-led integration into comprehensive BGF management.

20 Jul 2026·COPD-Journal of Chronic Obstructive Pulmonary Disease

A Real-World Prospective Observational Study to Describe the Safety Profile and Clinical Outcomes of Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF) In Chinese Patients with Chronic Obstructive Pulmonary Disease (COPD)

Article

Author: Zhang, Jing ; Sun, Yongchang ; Feng, Jiaxi ; Xu, Weiguo ; Zhou, Luqian ; Chen, Yunfeng ; Guo, Ruibin ; Zhang, Xiuwei ; Xiong, Xiaomin ; Li, Guoping

OBJECTIVES:

This observational, multicenter, prospective, single-arm study (NCT04536402) aimed to describe the safety profile and clinical outcomes of Budesonide/Glycopyrrolate/Formoterol Fumarate metered dose inhaler (BGF MDI) for Chinese patients with COPD in clinical practice.

METHODS:

COPD patients who had been prescribed and had planned to take at least one inhalation of BGF MDI were followed-up for 12 weeks at 4-week intervals. The primary endpoints were incidences of adverse events (AEs) and serious adverse events (SAEs). Secondary endpoints included changes from baseline in COPD Assessment Test (CAT) score and St George's Respiratory Questionnaire (SGRQ) score and patient global impression of change (PGIC) scale at week 4. Patients were also stratified into subgroups according to the asthma history, exacerbation history, and baseline treatment and assessed.

RESULTS:

Of the enrolled 3,317 patients, 2,137 completed and 1,180 discontinued the study. No unexpected safety signals were observed; most AEs were mild (13.2%) or moderate (7.2%). SAEs occurred in 4.9% of patients. BGF MDI was associated with decreased CAT and SGRQ total scores (mean [SD] changes from baseline: -6.7 [7.27], -14.5 [18.19]) and increased FEV₁ (189 mL, n = 241) at week 12. Similar trend of improvement was also observed in the subgroups. At week 4, 84.8% rated overall PGIC status as "improved," and 87.6% were satisfied with the MDI device.

CONCLUSION:

In real-world practice, BGF MDI demonstrated good tolerability consistent with previous RCTs, and associated with a trend toward improvement in patients' symptoms, quality of life, and lung function, regardless of asthma history, exacerbation history, or baseline treatment.

TRIAL REGISTRATION:

NCT04536402 (ClinicalTrials.gov), registered on 28 August 2020.

News (Medical) associated with Budesonide/Formoterol fumarate/Glycopyrronium Bromide

08 Sep 2026

·www.fiercebiotech.com

AZ's R&D chief Barr touts internal 'science success story' after IL-33 antibody's stellar showing in COPD

With a detailed data drop that AstraZeneca’s R&D chief described as an internal “science success story,” the British Big Pharma has secured an FDA priority review for what it believes could become a flagship biologic in chronic obstructive pulmonary disease (COPD). In detailed results from the late-stage Oberon and Titania trials—first teased in March and detailed in full at the European Respiratory Society Congress in Barcelona this week—the drugmaker laid out the extent of its IL-33 inhibitor’s potential to reduce moderate and severe exacerbations in a wide range of COPD patients still struggling with those “lung attacks,” as AstraZeneca’s Sharon Barr, Ph.D., called them, despite using standard-care inhaled therapy. In the headline results, a 300 mg dose of tozorakimab given once every four weeks curbed those moderate and severe exacerbations in the studies’ primary population of former smokers by 29% in the Oberon study and 34% in Titania. In the overall population of both current and former smokers, these reductions were 30% and 29%, respectively, versus placebo and inhaled standard of care. The benefits also extended to clinically meaningful exacerbation reductions in all prespecified patient subgroups and specifically turned up promising signals in patients across a range of blood eosinophil counts, with Barr telling Fierce that “it’s the details that make this even more exciting than the high-level results that we’ve already shared.” In fact, during AZ’s tozorakimab poster presentation at the ERS 2026 Congress this past weekend, attendees were so enamored by the data that event organizers had to encourage people to clear the room and look at the other presentations on offer, Barr said in an interview. “I think it really speaks to the fact that there is a lot of buzz around these data because the entire respiratory community has been so desperate for new therapies for these patients,” she explained. The respiratory disease continues to represent a “staggering unmet medical need,” Barr said, highlighting the COPD exacerbations that the Oberon and Titania studies homed in on, which she added carry a greater mortality risk than a heart attack. “When a patient has a severe exacerbation, only about half of them are still alive within three and a half years,” she pointed out. As for tozorakimab specifically, Barr christened the molecule “an AstraZeneca science success story,” harkening several years back to the point at which researchers began to explore IL-33 as a driver of respiratory disease, and COPD in particular. At the same time, “there was still so much that wasn’t understood,” she admitted, highlighting the insight that IL-33 signals through both ST2 and EGFR through the RAGE pathway, a discovery Barr attributed to AstraZeneca's own scientists. Understanding the need to tackle both pathways in COPD—and aware of competitor candidates in the hopper, including one that bound ST2—the company ultimately had to make some “courageous decisions,” Barr said. These included taking a prior COPD molecule offline and going back to the drawing board to reinvent its potential IL-33 label “to make sure that we had a molecule that could block signaling through both arms of the pathway, through both the reduced form and the oxidized form, knowing that we wouldn’t be first, but striving to be best.” “When we put [tozorakimab] into the clinic, we firmly believed that we had a differentiated molecule, and we saw the other molecules blocking just ST2 or partially blocking IL-33, unable to deliver two positive pivotal studies in COPD,” Barr explained. “We kept marching forward because we believed our molecule was differentiated, and now I think we have the clinical validation that supports that.” Ultimately, AstraZeneca finds itself on much better footing these days when it comes to potential biologic rivals to tozorakimab in COPD. Sanofi and Regeneron’s Dupixent, for instance, is approved to treat COPD exacerbations in patients with high eosinophil counts, but not low ones. Meanwhile, the future has become cloudier for other next-gen IL-33 candidates from Sanofi and Regeneron, as well as Roche, which have suffered trial flops in recent years. One other potential ingredient for AstraZeneca’s success in its duo of studies was that the company was “ambitious in the trial design, willing to look at an all-comers population,” Barr said, “and willing to enroll the most severe patients.” Prior studies for would-be biologics rivals in COPD “avoided enrolling” those patients, she pointed out. She also highlighted the Big Pharma’s painstaking design of exacerbations in its trial, which “gave us a very rigorous readout,” and pointed to “the extra effort and investment” the company put in to understand the effect of mucus plugs in patients. Barr described mucus production as a “key feature in disease diversity,” noting that mucus plugs—obstructing clumps of mucus that block patients’ airways—are associated with worse outcomes in COPD. In its data announcement, AstraZeneca noted that an integrated analysis of Oberon and Titania found tozorakimab “demonstrated a reduction in patients’ mucus plug score,” with the pharma claiming its biologic is the first to deliver such results in a broad COPD population. “So being able to reduce those mucus plugs, we expect, is an important part of driving benefit for patients who are living with COPD,” Barr said. Again touching on the breadth of the study populations, Barr added that tozorakimab “worked across all eosinophil levels in both current and former smokers across all levels of lung function,” which she suggested, “really simplifies decision-making for clinicians, and it allows them to offer therapy to the broadest possible patient population.” In the highest patient eosinophil count group, tozorakimab helped chart a 43% reduction in exacerbation risk, which Barr stressed were “unprecedented data.” In the mid-level group, AZ’s drug delivered a 23% reduction and, in the lowest group, a 34% reduction in eosinophils, which Barr said suggests efficacy “in all patient subgroups.” As for AZ’s recent guidance upgrade on the medicine’s sales opportunity, the lift from a $3 billion to $5 billion range to $5 billion plus was informed by multiple factors, Barr said, including the fact that “in 2024, there were multiple competitors, and there aren’t any more.” Additionally, “we know that this is a massive unmet medical need, and this is a really incredible set of data that we think will be very convincing to the clinical community,” Barr said. Looking ahead to a potential evolution of the COPD treatment landscape, Barr noted that most patients start treatment in the community with an option like a triple therapy, and for them, having an option like AstraZeneca’s inhaler Breztri will remain a “really important part” of that journey. But of the patients uncontrolled on triple therapy, which Barr described as “about half of them today,” just a “small fraction” are currently eligible for biologic therapy, which she emphasized AstraZeneca is working to change. Understanding that COPD is not a “one-size-fits-all” disease, AstraZeneca is also looking at its antibody drug Tezspire for patients with T2-driven disease, and the company continues to think about new mechanisms for tackling COPD through both systemic and inhaled drugs, Barr said.

04 Sep 2026

·www.fiercepharma.com

AZ leans on AI-generated llama to promote LAMA combo inhaler Breztri in new campaign

With the help of AI, AstraZeneca’s three-in-one inhaler Breztri has a new furry mascot to help it stand tall over the crowded asthma drug field. Breztri, which recently scored an expanded asthma indication after taking home its first chronic obstructive pulmonary disease (COPD) nod in 2020, combines a long-acting muscarinic antagonist (LAMA) with an inhaled corticosteroid (ICS) and a long-acting beta 2 -adrenergic agonist (LABA). Playing on the LAMA drug class name, AZ’s new Breztri campaign features an AI-generated llama in an unexpected office setting to urge patients to “put a LAMA to work.” In the one-minute spot , a business-casual llama works a late night in the office with his coworkers, a goat and an oryx, as a voiceover explains the attributes of the only three-in-one asthma maintenance inhaler for those 12 years of age and older. The trio goes on to take part in typical and humorous workplace scenarios, such as the automated lights going off or one goat colleague pressing all of the elevator buttons. The clever way of transforming complex treatment terminology into an animal that shares its namesake was AstraZeneca’s way of “breaking through that noise” to provide asthma education in a way that was “really meaningful,” AZ marketing senior director Katie Pansegrau explained in an interview with Fierce Pharma Marketing. “We were going to need to do something clever,” Pansegrau recalled. Of course, putting a real-life llama in a tie and a cubicle might be a tall task. Thus, the idea “kind of led itself to AI,” Pansegrau said. Edelman, which teamed up with AZ to create the campaign, used the help of AI tools to help it through each step of its traditional production process. While it was necessary to help “make a llama walk and push an elevator button,” the technology “never changed our standards” or the education goal of the campaign, Pansegrau emphasized. “No matter what tools we use to make the work, this work had to disrupt,” Edelman SVP and group creative director Brian Wood added. “It had to break through.” Still, the campaign could stand as a “shining example of what it can mean for future work,” Wood noted, referring to AI’s creative prowess. Aside from the overt humor of the animals-in-the-office situation, the ad is full of subtle winks, such as the onyx working on “herd dynamics” slides and posters in the office displaying barnyard puns. The comedic aspect of the campaign hearkens back to AZ’s goal of breaking through the noise and helping “drive understanding” for patients, Pansegrau pointed out. “This triple therapy, we believe, is something that every patient that's eligible should know about," Wood said. "LAMA certainly helped us make that message more memorable and, frankly, more entertaining,” Wood said. AZ plans to spread the ad across connect channels and social media platforms where it can best make its audience “stop the scroll,” according to Pansegrau. The company’s marketing for the drug has long leaned on creative themes, such as an animated approach that depicts patients walking into a colorful world upon starting on Breztri or its vacation-themed promotions that sees people transported into an RV or a cruise ship thanks to the med. Last year, Breztri picked up $1.2 billion in annual sales for AZ as one of its key blockbuster products, rising 23% from 2024. The new asthma nod Breztri earned earlier this year is expected to further help the drug chip in on the company’s goal of reaching $80 billion in revenues by 2030.

30 Jul 2026

·www.astrazeneca.com

AstraZeneca’s fixed-dose triple-combination Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF (320/28.8/9.6μg)) has been recommended for approval in the European Union (EU) for the maintenance treatment of asthma in patients 12 years of age and older who are not adequately controlled by a combination of a medium dose inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA). Trixeo Aerosphere, marketed as Breztri Aerosphere in the US, China and Japan,is a single inhaler that combines the efficacy of ICS/LABA with a long-acting muscarinic antagonist (LAMA). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the KALOS and LOGOS Phase III trials, in which Trixeo demonstrated statistically significant improvements in lung function compared with combined ICS/LABA comparators.1 In the pooled analysis of KALOS and LOGOS, Trixeo demonstrated a statistically significant reduction in the annualised rate of severe asthma exacerbations versus combined ICS/LABA comparators in a broad population of patients including those with no asthma exacerbations in the previous year.1 Alberto Papi, Professor and Chair of Respiratory Medicine at the University of Ferrara, and Director of the Respiratory Unit, CardioRespiratory Department, S. Anna University Hospital, Ferrara, Italy, and primary investigator, said: “Across Europe, millions of people with asthma still experience reduced lung function, breathing difficulties, exacerbations and significant disruption to daily life due to uncontrolled disease. The CHMP positive opinion for Trixeo represents an important step forward, offering a potential new treatment option that could help reduce exacerbations and improve disease control for patients living with asthma independent of their prior exacerbation history.” Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: “Building on the recent FDA approval for Breztri/Trixeo in asthma, we are pleased by the positive CHMP recommendation, which underscores the potential of this fixed-dose triple-combination therapy to improve outcomes for patients in Europe who continue to experience uncontrolled disease. The continued momentum of Trixeo across both asthma and COPD reflects our ambition to help transform respiratory care by delivering meaningful improvements in treatment outcomes by reducing the risk of exacerbations for patients.” In a key secondary endpoint, Trixeo demonstrated a rapid onset of action with a significant improvement from baseline in lung function within five minutes after the first dose.1 Trixeo is a maintenance therapy and is not used to relieve sudden breathing problems and will not replace a rescue inhaler. Results from KALOS and LOGOS were published in The Lancet Respiratory Medicine in February 2026.1 There were no new safety or tolerability signals identified for Trixeo in the trials.1 In Europe, there are nearly 43 million people living with asthma, and every year, about four million more people are newly diagnosed.2 When uncontrolled on dual therapies, patients can often struggle with symptoms such as wheezing, breathlessness, coughing exacerbations and even death.3-5 Trixeo/Breztri, is approved in the US for treatment of asthma, with regulatory filings currently under review in other major regions, including Japan and China. Trixeo/Breztri is also approved for the treatment of COPD in adults in 90 countries worldwide including the US, EU, China and Japan. Notes Asthma Asthma is a prevalent, chronic respiratory disease affecting as many as 363 million people worldwide,including nearly 43 million people in Europe.2,6 Around half of patients continue to be uncontrolled on dual therapies, leading to inflammation and muscle tightening in the airway (bronchoconstriction) that cause wheezing, breathlessness, chest tightness, coughing exacerbations and even death.3-5 Many patients remain uncontrolled despite the availability of standard of care medicines and continue to experience significant limitations on lung function and reduced quality of life.4,5 KALOS and LOGOS Phase III trials KALOS and LOGOS were replicate confirmatory, randomised, double-blind, double-dummy, parallel group, multi-centre, 24-to-52-week variable length Phase III trials to assess the efficacy and safety of Breztri/Trixeo Aerosphere compared with two fixed-dose, dual-combination therapies of budesonide, an ICS, and formoterol fumarate, a LABA: Symbicort pressurised metered-dose inhaler (pMDI) and PT009 (in an Aerosphere formulation).1,7,8 KALOS and LOGOS included approximately 4,300 randomised patients.7,8 In the data package submitted to the EMA, in the individual trials, the primary lung function endpoint was change from baseline in morning pre-dose trough FEV1 over 24 weeks, and the key secondary endpoint was change from baseline in FEV1 AUC0-3 over 24 weeks, versus dual therapy (the ICS/LABA treatment groups combined).1 The pooled primary endpoint using data from both KALOS and LOGOS trials, and prioritised in the testing procedure, was the rate of severe asthma exacerbations versus dual therapy (ICS/LABA) treatment groups combined.1 The primary and secondary endpoints and treatment comparisons in the KALOS and LOGOS trials differed according to regulatory submission approaches.1 Breztri/Trixeo Aerosphere Budesonide/glycopyrronium/formoterol fumarate or budesonide/glycopyrrolate/formoterol fumarate, is 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 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 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 for the treatment of COPD in more than 90 countries worldwide including the US, EU, China, Japan, and was prescribed to more than 6.8 million patients globally in 2025.9 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 commercialisation of prescription medicines in Oncology, Rare Disease, 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. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References Corporate and financial

Phase 3Clinical ResultDrug Approval

100 Deals associated with Budesonide/Formoterol fumarate/Glycopyrronium Bromide

External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Asthma	South Korea	AstraZeneca Korea Co. Ltd.	09 Nov 2021
Bronchitis, Chronic	Japan	AstraZeneca KK	18 Jun 2019
Pulmonary Disease, Chronic Obstructive	Japan	AstraZeneca KK	18 Jun 2019
Pulmonary Emphysema	Japan	AstraZeneca KK	18 Jun 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Moderate chronic obstructive pulmonary disease	Phase 3	United States	Pearl Therapeutics, Inc.	20 Aug 2015
Moderate chronic obstructive pulmonary disease	Phase 3	United States	AstraZeneca Dunkerque Production SCS	20 Aug 2015
Moderate chronic obstructive pulmonary disease	Phase 3	United States	AstraZeneca Investment (China) Co. Ltd.	20 Aug 2015
Moderate chronic obstructive pulmonary disease	Phase 3	Japan	AstraZeneca Investment (China) Co. Ltd.	20 Aug 2015
Moderate chronic obstructive pulmonary disease	Phase 3	Japan	AstraZeneca Dunkerque Production SCS	20 Aug 2015
Moderate chronic obstructive pulmonary disease	Phase 3	Japan	Pearl Therapeutics, Inc.	20 Aug 2015
Moderate chronic obstructive pulmonary disease	Phase 3	Canada	AstraZeneca Investment (China) Co. Ltd.	20 Aug 2015
Moderate chronic obstructive pulmonary disease	Phase 3	Canada	Pearl Therapeutics, Inc.	20 Aug 2015
Moderate chronic obstructive pulmonary disease	Phase 3	Canada	AstraZeneca Dunkerque Production SCS	20 Aug 2015
Severe chronic obstructive pulmonary disease	Phase 3	United States	Pearl Therapeutics, Inc.	20 Aug 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04609904 (LOGOS, CTgov)	Phase 3	Asthma	2,187	BGF (BGF MDI 320/14.4/9.6 μg BID)	efpufhbaop(gqmpiucdid) = qbdfeyxjmh jtotviugob (jgbmjndaqi, 0.019) View more	-	02 Jul 2026
				BGF (BGF MDI 320/28.8/9.6 μg BID)	efpufhbaop(gqmpiucdid) = sczdiyxeiw jtotviugob (jgbmjndaqi, 0.015) View more
NCT04609878 (KALOS, CTgov)	Phase 3	Asthma	2,274	BGF (BGF MDI 320/14.4/9.6 μg BID)	ryjosgbwmt(tkcytdpxvm) = tvtpzbljev mnzmnruzsc (pazbpiivdr, 0.018) View more	-	30 Jun 2026
				BGF (BGF MDI 320/28.8/9.6 μg BID)	ryjosgbwmt(tkcytdpxvm) = ghnofbayay mnzmnruzsc (pazbpiivdr, 0.014) View more
NCT04609878 (KALOS, ATS2026)	Phase 3	Asthma	1,500	Budesonide/glycopyrrolate/formoterol fumarate (BUD/GLY/FOR)	qhikuelssy(rvkrgupsyr) = pebxtezqvv kzcwrnrujw (ybfuhgyyur, −55.23 - 27.55)	Positive	15 May 2026
				Fluticasone/umeclidinium/vilanterol (FF/UMEC/VI) (pooled doses)	vzjaubmnrn(xglqbdrjzh) = lrdpkgqrom rlonkvskts (pbdvfgvtnu )
KALOS (ATS2026)	Phase 3	Asthma	4,311	Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF) 36	qaxduylujx(wrfriodeqo) = oayqespqph jltuknfvgg (mqsythieho ) View more	Positive	15 May 2026
				Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF) 18	qaxduylujx(wrfriodeqo) = kauruxnvtf jltuknfvgg (mqsythieho ) View more
KALOS (ATS2026)	Phase 3	Asthma	4,311	Budesonide/Glycopyrrolate/Formoterol Fumarate Aerosphere Co-suspension Delivery Technology 320/36/9.6 µg	ffowwfueab(lcckvyexwj) = sharwjvjki fhhddrjxev (fwluqtsxti, 9.0) View more	Positive	15 May 2026
				Budesonide/Glycopyrrolate/Formoterol Fumarate Aerosphere Co-suspension Delivery Technology 320/18/9.6 µg	ffowwfueab(lcckvyexwj) = mhrtxktpik fhhddrjxev (fwluqtsxti, 9.0) View more
KALOS (ATS2026)	Phase 3	Asthma	4,311	Budesonide/Glycopyrrolate/Formoterol Fumarate Aerosphere 36	asvjaekidt(wvtbuntkwo) = emspdhawyd qlhimedxcl (xpaxgbgedq )	Positive	15 May 2026
				Budesonide/Glycopyrrolate/Formoterol Fumarate Aerosphere 18	asvjaekidt(wvtbuntkwo) = ocxocpsilv qlhimedxcl (xpaxgbgedq )
NCT04609878 \| NCT04609904 (KALOS, Pubmed \| Lancet Respir Med)	Phase 3	Asthma	8,820	Budesonide-glycopyrronium-formoterol fumarate dihydrate 320 µg, 28.8 µg, 10 µg	gssapjnfnr(gelglspgni) = zgnitgecse drvuhyopmv (nawsoxubaa )	Positive	01 Apr 2026
				Budesonide-glycopyrronium-formoterol fumarate dihydrate 320 µg, 14.4 µg, 10 µg	gssapjnfnr(gelglspgni) = vblaggevle drvuhyopmv (nawsoxubaa )
KALOS (AAAAI2026)	Phase 3	Asthma	4,311	Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF) 320/36/9.6	ubqtublfgj(grjesfdmtx) = Over 24 weeks, least square mean differences (95% CIs) favored BGF 36 versus BUD/FORM (all p<0.001) for change from baseline (mL) for FEV1 AUC0-3 (KALOS: none [101 (52, 149)], 61 [68 (33, 103)]; LOGOS: none [102 (61, 143)], 61 [109 (66, 151)]). pjgtnhoeoa (bdjrjtolma ) View more	Positive	27 Feb 2026
				Symbicort (BUD/FORM) 320/9
NCT05573464 (CTgov)	Phase 3	Pulmonary Disease, Chronic Obstructive	559	BGF MDI HFA 320/14.4/9.6 μg	wczorrqobn = nxmxyvdbca vshtyrwlbq (fuxzalkucf, jcagouwilz - ommzblmuyg) View more	-	19 Sep 2025
NCT05477108 (CTgov)	Phase 1	Pulmonary Disease, Chronic Obstructive	108	BGF (Treatment A)	jtqouwkvub(pvrevqnten) = bzvgvbdgii hfpnwepyoe (fckoroikss, 61.09) View more	-	28 May 2025
				BGF (Treatment B (Replicate 1))	jtqouwkvub(pvrevqnten) = mfkbvgcang hfpnwepyoe (fckoroikss, 63.42) View more

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