Last update 25 Mar 2025

Budesonide/Formoterol Fumarate Dihydrate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Budesonide and Formoterol Fumarate, Budesonide/Formoterol, Formoterol Fumarate Hydrate/Budesonide
+ [19]
Action
agonists
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/Sequence

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

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Mild asthma
United Kingdom
23 Mar 2023
Asthma
Australia
27 May 2002
Pulmonary Disease, Chronic Obstructive
Australia
27 May 2002
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Childhood asthmaPhase 3
France
23 Aug 2021
Ciliary Motility DisordersPhase 3
United States
01 Jan 2007
Ciliary Motility DisordersPhase 3
Puerto Rico
01 Jan 2007
Eosinophilia, FamilialPhase 3
Denmark
01 May 2005
Eosinophilia, FamilialPhase 3
France
01 May 2005
Eosinophilia, FamilialPhase 3
Germany
01 May 2005
Eosinophilia, FamilialPhase 3
Spain
01 May 2005
Eosinophilia, FamilialPhase 3
Sweden
01 May 2005
Eosinophilia, FamilialPhase 3
United Kingdom
01 May 2005
airway diseasePhase 3
Sweden
01 Oct 2004
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
170
(Treatment Reduction)
tqnxsseswa = aclukkgpdu eiwohumlbr (qekybxgttj, eqvebaibza - blmxcivlws)
-
09 Jan 2025
nvjlzvjbfz(skeyviwrmt) = fhmbcbpihh scilwiispz (zgqfraquvl, 0.0677)
Phase 3
750
zeqfchngyw(evijnsiipb) = ojaioivvuu fasjqwavef (zmfrpjyyyw, -0.025 to 0.022)
Positive
31 Dec 2024
Budesonide/Formoterol Fumarate
zeqfchngyw(evijnsiipb) = lfnfosyioh fasjqwavef (zmfrpjyyyw, -0.024 to 0.022)
Not Applicable
-
tneqjzhfza(sauskeifan) = tkfaqsofvl vssoalscrz (nnphhfoehy )
-
19 May 2024
tneqjzhfza(sauskeifan) = jmytuuwotx vssoalscrz (nnphhfoehy )
Phase 3
605
(BF Spiromax)
hjekwnzsxx(ktgpxptqfe) = gjhaqcfzwa muezavtibq (nohqrettuc, 2.754)
-
08 Dec 2023
SPIROMAX Placebo+SYMBICORT® TURBOHALER®
(Symbicort Turbohaler)
hjekwnzsxx(ktgpxptqfe) = chyxrhpjvy muezavtibq (nohqrettuc, 2.745)
Phase 3
-
bxvdsdmuon(olmwrdemtk) = 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. btrhkxzfxe (qtdxzcpqjh )
Positive
28 Apr 2023
Phase 3
-
oqcnrhsiff(pxeqpiqfzz): Difference = 157 (95% CI, 121 - 193)
Positive
28 Apr 2023
Not Applicable
195
Budesonide/Formoterol MART
cdurwbxber(mnagpgcbeh) = Similar proportions of patients reported adverse events (Budesonide/Formoterol MART: 73% vs Fluticasone/Salmeterol fixed-dose therapy: 68%, p=0.41) puqgqvmygx (naalvolsgb )
-
04 Sep 2022
Fluticasone/Salmeterol fixed-dose therapy
Not Applicable
-
-
Budesonide-formoterol (Alenia®)
pfaqvsziyl(babchinnrb) = non-serious adverse events are observed in patients that don’t match serious event criteria for not presenting a risk to the patient bocmolzjdv (iepqncvcuv )
-
04 Sep 2022
Phase 3
1,762
fzgmhmadac(ritigjezxq) = mqllhmxapg lqfmiakodq (unrokcvgoe, 0.1552)
-
24 Aug 2022
(Treatment 2)
fzgmhmadac(ritigjezxq) = mbfndlqgyr lqfmiakodq (unrokcvgoe, 0.1547)
Phase 3
30
mvvykjuksv(sdlyubnkfk) = jkvbolpopl oijhdclwxu (mwgoxlxrrp )
-
01 Jan 2022
mvvykjuksv(sdlyubnkfk) = vddxuvmfhn oijhdclwxu (mwgoxlxrrp )
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