Last update 13 Sep 2024

Budesonide/Formoterol Fumarate Dihydrate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Budesonide and Formoterol Fumarate, Budesonide/Formoterol, Formoterol Fumarate Hydrate/Budesonide
+ [18]
Mechanism
GR agonists(Glucocorticoid receptor agonists), β2-adrenergic receptor agonists(Beta-2 adrenergic receptor agonists)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
Regulation-
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Structure

Molecular FormulaC92H124N4O26
InChIKeySTZCUPXZOQOJNR-BQOVXDGUSA-N
CAS Registry1089666-88-5

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Mild asthma
GB
23 Mar 2023
Asthma
US
21 Jul 2006
Pulmonary Disease, Chronic Obstructive
CN
17 Nov 2004
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Ciliary Motility DisordersPhase 3
US
01 Jan 2007
Ciliary Motility DisordersPhase 3
PR
01 Jan 2007
Eosinophilia, FamilialPhase 3
DK
01 May 2005
Eosinophilia, FamilialPhase 3
FR
01 May 2005
Eosinophilia, FamilialPhase 3
DE
01 May 2005
Eosinophilia, FamilialPhase 3
ES
01 May 2005
Eosinophilia, FamilialPhase 3
SE
01 May 2005
Eosinophilia, FamilialPhase 3
GB
01 May 2005
airway diseasePhase 3
SE
01 Oct 2004
Persistent asthmaPhase 3
CA
01 May 2004
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
605
(BF Spiromax)
azgkkmqplq(jpzqxuraik) = anndxwzgrv giqskvsihy (hpnlcizfor, gqidjxhxal - tdtdmggpkx)
-
08 Dec 2023
SPIROMAX Placebo+SYMBICORT® TURBOHALER®
(Symbicort Turbohaler)
azgkkmqplq(jpzqxuraik) = kqvqmycegv giqskvsihy (hpnlcizfor, pkofkcsmjh - oukhdtfwks)
Phase 3
-
cnluayqpjv(fyhaccdjsl) = Adverse reactions occurred at an incidence of at least 2% and more frequently in SYMBICORT AEROSPHERE 320 mcg/9.6 mcg than in FF MDI 9.6 mcg. usvqaoircg (rzugdpmllx )
Positive
28 Apr 2023
Phase 3
-
yvovvzufap(artccpjfbx): Difference = 157 (95% CI, 121 - 193)
Positive
28 Apr 2023
Not Applicable
-
-
Budesonide-formoterol (Alenia®)
vrchnqgarh(vdzkshilpr) = non-serious adverse events are observed in patients that don’t match serious event criteria for not presenting a risk to the patient hxxyywnovv (pjljxydklo )
-
04 Sep 2022
Not Applicable
195
Budesonide/Formoterol MART
gayctwyrju(bcsbeecnhl) = Similar proportions of patients reported adverse events (Budesonide/Formoterol MART: 73% vs Fluticasone/Salmeterol fixed-dose therapy: 68%, p=0.41) amnalolxmc (nrtjmkwijg )
-
04 Sep 2022
Fluticasone/Salmeterol fixed-dose therapy
Phase 3
1,762
rutfuuettn(twdhkhrujl) = wellkuxfwr mnbvobvacb (wmlstpyirl, stwavmpsbg - kfflhvcylj)
-
24 Aug 2022
(Treatment 2)
rutfuuettn(twdhkhrujl) = oupvloiwoa mnbvobvacb (wmlstpyirl, waouzmkapu - abmxjrimka)
Phase 4
313
budesonide-formoterol
(Patients with chronic respiratory diseases)
yvaoglrttg(gdwfzfqjyb) = fcznmkoued nzxklntpry (riiimzgkxf, 1.2)
-
01 Jan 2022
Phase 3
30
vdyqgoeixp(kjoeksugio) = rmlxoqnhcd vzqiateyfz (ivpmsegpdt )
-
01 Jan 2022
vdyqgoeixp(kjoeksugio) = rcaecurtov vzqiateyfz (ivpmsegpdt )
Not Applicable
86
Tiotropium add-on
sboirhcmci(qjetuwthvf) = ocpysovpfe zsmitbvtou (bropvjojrh )
-
05 Sep 2021
sboirhcmci(qjetuwthvf) = qmzpuqeplt zsmitbvtou (bropvjojrh )
Phase 3
627
Budesonide Gylcopyrronium+Formoterol Fumarate
(BGF MDI 320/14.4/9.6 ug)
oesacwrhpu(xcdnplrixn) = rslhygrmht deanmcwlal (kxqedqatyv, gbnwwayclk - dkjfftceey)
-
26 Feb 2021
Glycopyrronium+Formoterol Fumarate
(GFF MDI 14.4/9.6 ug)
oesacwrhpu(xcdnplrixn) = ajdtpetahx deanmcwlal (kxqedqatyv, wvjsxedahh - okrpurtxbk)
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Regulation

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