Last update 06 May 2026

Budesonide/Formoterol fumarate/Glycopyrronium Bromide

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
BGF MDI, Breztri Aerosphere, Budesonide/formoterol fumarate/glycopyrronium
+ [18]
Action
agonists, antagonists
Mechanism
GR agonists(Glucocorticoid receptor agonists), mAChRs antagonists(Muscarinic acetylcholine receptor antagonists), β2-adrenergic receptor agonists(Beta-2 adrenergic receptor agonists)
Inactive Indication-
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
Regulation-
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Structure/Sequence

Molecular FormulaC25H34O6
InChIKeyVOVIALXJUBGFJZ-KWVAZRHASA-N
CAS Registry51333-22-3
View All Structures (3)

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Asthma
United States
27 Apr 2026
Bronchitis, Chronic
Japan
18 Jun 2019
Pulmonary Disease, Chronic Obstructive
Japan
18 Jun 2019
Pulmonary Emphysema
Japan
18 Jun 2019
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Moderate chronic obstructive pulmonary diseasePhase 3
United States
20 Aug 2015
Moderate chronic obstructive pulmonary diseasePhase 3
United States
20 Aug 2015
Moderate chronic obstructive pulmonary diseasePhase 3
United States
20 Aug 2015
Moderate chronic obstructive pulmonary diseasePhase 3
Japan
20 Aug 2015
Moderate chronic obstructive pulmonary diseasePhase 3
Japan
20 Aug 2015
Moderate chronic obstructive pulmonary diseasePhase 3
Japan
20 Aug 2015
Moderate chronic obstructive pulmonary diseasePhase 3
Canada
20 Aug 2015
Moderate chronic obstructive pulmonary diseasePhase 3
Canada
20 Aug 2015
Moderate chronic obstructive pulmonary diseasePhase 3
Canada
20 Aug 2015
Severe chronic obstructive pulmonary diseasePhase 3
United States
20 Aug 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
8,820
Budesonide-glycopyrronium-formoterol fumarate dihydrate 320 µg, 28.8 µg, 10 µg
drelogocyk(pcinvvnxpn) = wshdlgjenf kjxnhqgnbe (moqizxkhiz )
Positive
01 Apr 2026
Budesonide-glycopyrronium-formoterol fumarate dihydrate 320 µg, 14.4 µg, 10 µg
drelogocyk(pcinvvnxpn) = bkcwpmgrlg kjxnhqgnbe (moqizxkhiz )
Phase 3
4,311
Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF) 320/36/9.6
osxklkqxwj(hbsjayjdbj) = 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)]). nlccazvnck (duqrhcteir )
Positive
27 Feb 2026
Symbicort (BUD/FORM) 320/9
Phase 3
559
kixcaplgpi = tgbgceycjg lfwevdxeyd (ojizenllrd, xdubdfqafe - uowtmvyvvq)
-
19 Sep 2025
Phase 1
108
(Treatment A)
btdvgwcdon(gmacutonaw) = pzfccukfek ktgxbopxua (peruajuqlc, 61.09)
-
28 May 2025
(Treatment B (Replicate 1))
btdvgwcdon(gmacutonaw) = mlixitgthz ktgxbopxua (peruajuqlc, 63.42)
Not Applicable
8,837
Prompt initiation of Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF)
mpnsyrqzsz(yvjltlmhdt) = edsrqemuao miykswtnck (haanbwsdpp, 1.30 - 1.45)
Positive
16 May 2025
Delayed initiation of Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF)
mpnsyrqzsz(yvjltlmhdt) = wmgjfqogtq miykswtnck (haanbwsdpp, 1.85 - 1.94)
Phase 3
-
qggtgmofey(hvvebquvoi) = met all primary endpoints cjiyiltokv (wqlrwgyrcy )
Met
Positive
02 May 2025
Budesonide and formoterol fumarate
Phase 3
-
ucrpakagax(nillgjzytj) = met all primary endpoints tcixvwtmvz (xizctehjgj )
Met
Positive
02 May 2025
Budesonide and formoterol fumarate (BFF) MDI 320/9.6 μg
Phase 1
108
BAB+BGF
(Treatment A)
cqjkykiwhe(vrtrysselk) = ffkqqydazw frgrjqqbzj (geovwuiiaz, 46.71)
-
29 Apr 2025
BAB+BGF
(Treatment B (Replicate 1))
cqjkykiwhe(vrtrysselk) = rgcuggzutx frgrjqqbzj (geovwuiiaz, 40.78)
Not Applicable
-
Budesonide/glycopyrronium/formoterol fumarate co-suspension metered dose inhaler (BGF MDI)
riznqlzzhz(hmcpdunkzl) = Three participants in the BGF MDI group reported palpitations, with no other complications noted khsxirmsox (bdserpbjgz )
Positive
01 Apr 2025
Budesonide/glycopyrronium/formoterol fumarate co-suspension metered dose inhaler
(Control group)
Not Applicable
2,342
ykxraptvmy(gwwsbnsvgc) = bphdluejqe hoxqvbeqzs (ddjmnpbwvi )
Positive
07 Sep 2024
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Regulation

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