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) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date Japan (18 Jun 2019), |
Regulation- |
Molecular FormulaC25H34O6 |
InChIKeyVOVIALXJUBGFJZ-KWVAZRHASA-N |
CAS Registry51333-22-3 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| 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 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Moderate chronic obstructive pulmonary disease | Phase 3 | United States | 20 Aug 2015 | |
| Moderate chronic obstructive pulmonary disease | Phase 3 | United States | 20 Aug 2015 | |
| Moderate chronic obstructive pulmonary disease | Phase 3 | United States | 20 Aug 2015 | |
| Moderate chronic obstructive pulmonary disease | Phase 3 | Japan | 20 Aug 2015 | |
| Moderate chronic obstructive pulmonary disease | Phase 3 | Japan | 20 Aug 2015 | |
| Moderate chronic obstructive pulmonary disease | Phase 3 | Japan | 20 Aug 2015 | |
| Moderate chronic obstructive pulmonary disease | Phase 3 | Canada | 20 Aug 2015 | |
| Moderate chronic obstructive pulmonary disease | Phase 3 | Canada | 20 Aug 2015 | |
| Moderate chronic obstructive pulmonary disease | Phase 3 | Canada | 20 Aug 2015 | |
| Severe chronic obstructive pulmonary disease | Phase 3 | United States | 20 Aug 2015 |
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 ) View more | Positive | 27 Feb 2026 | ||
Symbicort (BUD/FORM) 320/9 | |||||||
Phase 3 | 559 | kixcaplgpi = tgbgceycjg lfwevdxeyd (ojizenllrd, xdubdfqafe - uowtmvyvvq) View more | - | 19 Sep 2025 | |||
Phase 1 | 108 | (Treatment A) | btdvgwcdon(gmacutonaw) = pzfccukfek ktgxbopxua (peruajuqlc, 61.09) View more | - | 28 May 2025 | ||
(Treatment B (Replicate 1)) | btdvgwcdon(gmacutonaw) = mlixitgthz ktgxbopxua (peruajuqlc, 63.42) View more | ||||||
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) View more | - | 29 Apr 2025 | ||
BAB+BGF (Treatment B (Replicate 1)) | cqjkykiwhe(vrtrysselk) = rgcuggzutx frgrjqqbzj (geovwuiiaz, 40.78) View more | ||||||
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 ) View more | 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 |





