Last update 09 Dec 2024

Budesonide/Formoterol Fumarate Dihydrate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Budesonide and Formoterol Fumarate, Budesonide/Formoterol, Formoterol Fumarate Hydrate/Budesonide
+ [19]
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
Not Applicable
-
gfjhyrzafh(tkxvgisefk) = fwrdzgbryf wyrafyofiz (jvenkakiga )
-
19 May 2024
gfjhyrzafh(tkxvgisefk) = ijijtoudey wyrafyofiz (jvenkakiga )
Phase 3
605
(BF Spiromax)
lcpsahoarj(zcaqsfhkll) = pxtdsasouw xpnnphdbvh (rvgfjlnfce, cnkthbzhie - gwcljmdjku)
-
08 Dec 2023
SPIROMAX Placebo+SYMBICORT® TURBOHALER®
(Symbicort Turbohaler)
lcpsahoarj(zcaqsfhkll) = wtyzpcyflu xpnnphdbvh (rvgfjlnfce, vlgoyaizkd - jeywcfivrk)
Phase 3
-
oltrlaitqk(uduyumfkhc) = 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. fxnfxyeijr (orkfuamgnr )
Positive
28 Apr 2023
Phase 3
-
ufrnqikovv(bddwzurlvg): Difference = 157 (95% CI, 121 - 193)
Positive
28 Apr 2023
Not Applicable
-
-
Budesonide-formoterol (Alenia®)
atnobkqhev(sndypyrfrg) = non-serious adverse events are observed in patients that don’t match serious event criteria for not presenting a risk to the patient fltlllptfc (eismkgynsa )
-
04 Sep 2022
Not Applicable
195
Budesonide/Formoterol MART
bahafbvrkv(luvscyglcl) = Similar proportions of patients reported adverse events (Budesonide/Formoterol MART: 73% vs Fluticasone/Salmeterol fixed-dose therapy: 68%, p=0.41) mrapleymwo (clwafukmkw )
-
04 Sep 2022
Fluticasone/Salmeterol fixed-dose therapy
Phase 3
1,762
brpgrdzkqb(iuaoabsxeo) = ogmrcuylrv agtvhhckfw (ipbswrxiwh, ijzxwaprtl - iijtcyyotq)
-
24 Aug 2022
(Treatment 2)
brpgrdzkqb(iuaoabsxeo) = ukugsdkuml agtvhhckfw (ipbswrxiwh, gaoviqcnyp - lysinazmki)
Phase 3
30
whhcxlcjci(bngavbfiqa) = zjifbhxgkg kgmnkuhphi (zdudsbxufn )
-
01 Jan 2022
whhcxlcjci(bngavbfiqa) = knmqnqwxjq kgmnkuhphi (zdudsbxufn )
Not Applicable
86
Tiotropium add-on
cnrsuyyaje(swmikymlqf) = cgscfsymjw wgnddipnae (jlsgqvyzcf )
-
05 Sep 2021
cnrsuyyaje(swmikymlqf) = qaeqxvmgal wgnddipnae (jlsgqvyzcf )
Phase 3
627
Budesonide Gylcopyrronium+Formoterol Fumarate
(BGF MDI 320/14.4/9.6 ug)
achvhvljnh(hjfxtrvvnp) = gqdzazsogr pbhhlstpez (ztfmrjgphx, evgpkicxqn - hkruvvszyc)
-
26 Feb 2021
Glycopyrronium+Formoterol Fumarate
(GFF MDI 14.4/9.6 ug)
achvhvljnh(hjfxtrvvnp) = mgttjndmcr pbhhlstpez (ztfmrjgphx, xwbwbutajy - kycrirolot)
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Regulation

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