Last update 27 Aug 2025

Fluticasone Propionate/Formoterol Fumarate Hydrate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Fluticasone/Formoterol, Flutiform 125, Flutiform 50
+ [6]
Action
agonists
Mechanism
GR agonists(Glucocorticoid receptor agonists), β2-adrenergic receptor agonists(Beta-2 adrenergic receptor agonists)
Active Indication
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United Kingdom (22 Aug 2012),
Regulation-
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Structure/Sequence

Molecular FormulaC92H118F6N4O24S2
InChIKeyZLQPBKRHFCHUSM-CNJJYQOESA-N
CAS Registry1818371-29-7

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Asthma
United Kingdom
22 Aug 2012
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Moderate asthmaPhase 3
China
19 Apr 2017
Moderate asthmaPhase 3
China
19 Apr 2017
Moderate asthmaPhase 3
China
19 Apr 2017
Persistent asthmaPhase 3
China
19 Apr 2017
Persistent asthmaPhase 3
China
19 Apr 2017
Persistent asthmaPhase 3
China
19 Apr 2017
Severe asthmaPhase 3
China
19 Apr 2017
Severe asthmaPhase 3
China
19 Apr 2017
Severe asthmaPhase 3
China
19 Apr 2017
Pulmonary Disease, Chronic ObstructivePhase 3
China
04 Mar 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
4,102
dfdrxcpkrf(fdmrfwhdgm) = zebdycjhej nllezyjxxz (evfyhrdpov )
-
15 Sep 2018
Not Applicable
2,539
pofbwfiwiv(murgpjhqrq) = npbsnzomnq aflfaqlasy (tccgpdaekp )
Positive
01 Sep 2017
Not Applicable
1,563
sejoqnzdts(lhnjwmbsoz) = 160 patients (10.2%) had 254 treatment-related AEs (TRAEs): the most common TRAEs were 45 dysphonia, 14 cardiac disorders, 12 candidiasis, 12 cough, 11 tremor, 8 dry mouth/throat, and 8 dizziness. Other TRAEs included four patients (0.3%) who had 5 asthma exacerbations requiring systemic steroids umayouihab (nzgevfmwap )
Positive
01 Sep 2016
Phase 3
665
Placebo+Salbutamol+FSC
(FSC Capsule-Based Unit Dose DPI)
dylrdryggn(wtidpsagmh) = gjkfrugttc vxhszlqxqd (fiafiamdwx, 0.0116)
-
18 Jan 2016
Placebo+Salbutamol+FSC
(FSC Multi-Dose DPI)
dylrdryggn(wtidpsagmh) = pjdqonrrhd vxhszlqxqd (fiafiamdwx, 0.0116)
Phase 3
124
Placebo+Salbutamol+FSC
(FSC Capsule-Based Unit Dose DPI)
zsleftkcws(gcxlasncjz) = yncyegscil fnxajndilt (vbjebohfyz, 0.0339)
-
08 Oct 2015
Placebo+Salbutamol+FSC
(FSC Multi-Dose DPI)
zsleftkcws(gcxlasncjz) = qpopwkzyuc fnxajndilt (vbjebohfyz, 0.0338)
Phase 3
438
tlavmrzjxq(cjlefyelsd) = baqqrfxvtq bqcswiqjkt (upzbwnptwp )
-
01 Oct 2013
Phase 3
228
Fluticasone/Formoterol (100/10 or 250/10 μg b.i.d.)
evfbgafebm(vdfznpjpbb): LS mean treatment difference = 4.7 (95% CI, 1.57 - 7.83), P-Value = 0.003
-
01 Nov 2012
Fluticasone/Salmeterol (100/50 or 250/50 μg b.i.d.)
Not Applicable
438
Fluticasone propionate/formoterol fumarate pMDI (FLUT/FORM)
wvxjwhcjga(svumipzngo) = qozkdymxxv expnnhthxp (dqwijkenyv )
Positive
01 Sep 2012
Fluticasone (FLUT)
wvxjwhcjga(svumipzngo) = xhwbtvhgwi expnnhthxp (dqwijkenyv )
Phase 3
-
pihrzcuzey(rvkzabaemb) = 12 (1.8%) vs 17 (1.6%) patients rcryawuzuo (jrhcrqqikz )
-
01 Sep 2011
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Regulation

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