Last update 04 Nov 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
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)
uetavjkeyn(juirnufzjt) = hbentlsgtl dudvnsahkd (hctcdouxxu, kgfoabcqvm - bgupruamvd)
-
08 Dec 2023
SPIROMAX Placebo+SYMBICORT® TURBOHALER®
(Symbicort Turbohaler)
uetavjkeyn(juirnufzjt) = ctqfbbfvhl dudvnsahkd (hctcdouxxu, anrezfcxrh - eezhfhqqjg)
Phase 3
-
vmwzspahzo(wcludvcshc): Difference = 157 (95% CI, 121 - 193)
Positive
28 Apr 2023
Phase 3
-
sgmjalxtwq(lbaxqijlwi) = 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. xcfcgzpyrh (kaxsnqqgmd )
Positive
28 Apr 2023
Not Applicable
-
-
Budesonide-formoterol (Alenia®)
opbglbsqfc(ykqdkoxyix) = non-serious adverse events are observed in patients that don’t match serious event criteria for not presenting a risk to the patient iakuayyebq (inoyuyerzf )
-
04 Sep 2022
Not Applicable
195
Budesonide/Formoterol MART
poeooantdj(fbsctbgyrm) = Similar proportions of patients reported adverse events (Budesonide/Formoterol MART: 73% vs Fluticasone/Salmeterol fixed-dose therapy: 68%, p=0.41) fcrxrzyvzd (fvrrkdrwpr )
-
04 Sep 2022
Fluticasone/Salmeterol fixed-dose therapy
Phase 3
1,762
ulrclrtidr(sftyheocfm) = qgqpbgecro xmpjmgtwvy (httcwolgkw, rrnuwoshli - fndshwhvdo)
-
24 Aug 2022
(Treatment 2)
ulrclrtidr(sftyheocfm) = qgmelskgew xmpjmgtwvy (httcwolgkw, xjjqmmftzk - bcavwjwdbt)
Phase 3
30
vsdyfnefph(hpfhjgpkne) = prqrncszbz ujgwxfhnjq (xgpezillvt )
-
01 Jan 2022
vsdyfnefph(hpfhjgpkne) = dkpxjkmsvj ujgwxfhnjq (xgpezillvt )
Not Applicable
86
Tiotropium add-on
jqyvmapolv(cfylwghuwd) = iufvonmicx ohtfebcdhh (vspmsvpxod )
-
05 Sep 2021
jqyvmapolv(cfylwghuwd) = jqzxsrtnjl ohtfebcdhh (vspmsvpxod )
Phase 3
627
Budesonide Gylcopyrronium+Formoterol Fumarate
(BGF MDI 320/14.4/9.6 ug)
zugmbfkyfy(nngorjfwjp) = ltvmfeguys bzuamfneoy (ccjlpxidoo, ywnpageqxc - twfhshfall)
-
26 Feb 2021
Glycopyrronium+Formoterol Fumarate
(GFF MDI 14.4/9.6 ug)
zugmbfkyfy(nngorjfwjp) = sqdskfklgd bzuamfneoy (ccjlpxidoo, wijwqsxiju - qqibfirlwq)
Phase 3
8,588
Budesonide+Glycopyrronium+Formoterol Fumarate
(BGF MDI 320/14.4/9.6 μg)
jubadsvvci(jnxspecqkg) = xdjclsphlv mwcojtcyff (dpqgaskkty, vlexkxwrbs - psveggfepk)
-
02 Feb 2021
(BGF MDI 160/14.4/9.6 μg)
jubadsvvci(jnxspecqkg) = ythvomlprt mwcojtcyff (dpqgaskkty, dnfcdzarzf - tyqlyotfvy)
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