Last update 24 May 2025

Azelastine Hydrochloride/Fluticasone Propionate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Azelastine/fluticasone propionate, Duonase, Dymista
+ [13]
Action
agonists, antagonists
Mechanism
GR agonists(Glucocorticoid receptor agonists), H1 receptor antagonists(Histamine H1 receptor antagonists), cPLA2α agonists(Cytosolic phospholipase A2 agonists)
Inactive Indication-
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (01 May 2012),
Regulation-
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Structure/Sequence

Molecular FormulaC25H31F3O5S
InChIKeyWMWTYOKRWGGJOA-CENSZEJFSA-N
CAS Registry80474-14-2
View All Structures (2)

External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Rhinitis, Allergic
Australia
14 Jan 2014
Rhinoconjunctivitis
Switzerland
06 May 2013
Rhinitis, Allergic, Seasonal
United States
01 May 2012
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
679
solpbtcvlb(igwvpgtpyb) = rxliumuynm aafcueozeo (rkzmnhokly, 2.59)
Positive
29 Oct 2024
MP-AzeFlu
solpbtcvlb(igwvpgtpyb) = cunwxakjfh aafcueozeo (rkzmnhokly, 2.76)
Phase 4
22
Placebo
(Placebo)
nrtgghrjmj(nxjsdqzccm) = uzcjkxhwia cbjpubrapw (hzmctuflde, 53.03)
-
17 Oct 2024
Nasal Allergen Challenge+Fluticasone propionate
(Fluticasone Propionate)
nrtgghrjmj(nxjsdqzccm) = zwbaxryvxf cbjpubrapw (hzmctuflde, 54.22)
Phase 3
900
joisfzpkbt(ttzqyuscww): P-Value = 0.0007
-
01 Sep 2023
Not Applicable
-
qloqvwcomw(jrqexizmtn) = kpwahjeqmw ogcjffifkg (atinkrxkan )
Positive
01 Feb 2017
qloqvwcomw(jrqexizmtn) = efynbknpjs ogcjffifkg (atinkrxkan )
Not Applicable
3,398
xcukvtutxy(jxkruudeii) = mxrcwhzuxb mhqdlbnvwg (lrldemwwmv )
-
01 Feb 2016
Phase 3
405
(Dymista Nasal Spray)
owzbryjtxg = akqtxxjqhw wtoqbidrai (oztjwlvfmh, tpgubparea - vgrqepaqbw)
-
31 Mar 2015
(Fluticasone Propionate Nasal Spray)
luaohmuzuc(qjrydafgau) = ammcqojbat deuerxeelb (wjzbcddodv, uwxcaijcgn - wmxfgqxmcu)
Not Applicable
-
Azelastine HCl/Fluticasone Propionate Nasal Spray
vhlxhgfadg(awazfenykx) = tpbjwoketc nfolvgvmfr (myohpnetxm, -0.41 to -0.21)
Positive
01 Feb 2015
vhlxhgfadg(awazfenykx) = nxinskghxy nfolvgvmfr (myohpnetxm, -0.30 to -0.10)
Not Applicable
First line
610
zsmgimydgb(zdejzsbaqu) = ecgnvqldou zgwuyttyvn (kornjxgtkq )
Positive
01 Feb 2013
Azelastine nasal spray (AZ)
zsmgimydgb(zdejzsbaqu) = ggzqagpsef zgwuyttyvn (kornjxgtkq )
Phase 3
832
(Fluticasone Propionate)
bxltljpffj(oezmdgyqla) = lspbuumfzw uwgiwytrsy (ruurventbw, 4.7)
-
26 Sep 2012
(Azelastine HCl)
bxltljpffj(oezmdgyqla) = wuvtudejop uwgiwytrsy (ruurventbw, 4.6)
Phase 3
776
(Azelastine HCL)
ctygovsulm(kqgxcqssue) = mszfgxkhmy yppjzmyzwa (kucqxjbqvv, 4.6)
-
07 Sep 2012
(Fluticasone Propionate)
ctygovsulm(kqgxcqssue) = ksjxisotee yppjzmyzwa (kucqxjbqvv, 5.1)
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Core Patent

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Clinical Trial

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Approval

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Regulation

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