Last update 25 Aug 2025

Azelastine Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
4-(p-Chlorobenzyl)-2-(hexahydro-1-methyl-1H-azepin-4-yl)-1-(2H)-phthalazinone, Afluon, Allergodil
+ [29]
Action
antagonists, stabilizers
Mechanism
H1 receptor antagonists(Histamine H1 receptor antagonists), Mast cells stabilizers
Originator Organization
Drug Highest PhaseApproved
First Approval Date
Japan (30 Apr 1986),
Regulation-
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Structure/Sequence

Molecular FormulaC22H25Cl2N3O
InChIKeyYEJAJYAHJQIWNU-UHFFFAOYSA-N
CAS Registry79307-93-0

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Respiratory Tract Infections
United States
17 Jun 2021
Rhinitis, Allergic, Perennial
Australia
21 Jul 2004
Conjunctivitis, Allergic
United States
22 May 2000
Rhinitis, Allergic, Seasonal
United States
01 Nov 1996
Rhinitis, Vasomotor
United States
01 Nov 1996
Dermatitis
Japan
30 Aug 1990
Eczema
Japan
30 Aug 1990
Prurigo
Japan
30 Aug 1990
Pruritus
Japan
30 Aug 1990
Urticaria
Japan
30 Aug 1990
Asthma
Japan
30 Apr 1986
Rhinitis, Allergic
Japan
30 Apr 1986
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Rhinitis perennialPhase 3
United States
01 Jan 2007
Chronic rhinitisPhase 3
United States
01 Jul 2006
Common ColdPhase 3
United States
01 Jul 2006
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
110
Azelastine HCl 0.15% nasal spray
rbonlqtdbn(lhgqdawsuu) = yykgpcjdae ydhgzwixrp (czvwvppdte )
Positive
01 Jul 2024
Not Applicable
87
Fluticasone propionate/azelastine (FP/Aze 50/137 μg each nostril twice daily)
vprywhrxyp(apgwnpgziv): mean difference = 1.26 (95% CI, 0.59 - 1.93), P-Value = <0.001
Positive
23 Feb 2024
Fluticasone furoate (FF 55 μg each nostril once daily)
Phase 3
900
hwgovzbqtv(clsmevfgiu): P-Value = 0.0007
-
01 Sep 2023
Fluticasone propionate nasal spray
Phase 3
581
gdcaubugbo(jsszmtcfyu) = lnsdsupijq ztynupqeqv (vtxsunobys, 3.99)
Positive
01 Jan 2023
gdcaubugbo(jsszmtcfyu) = vfkyfapdzq ztynupqeqv (vtxsunobys, 4.26)
Pubmed
ManualManual
Phase 4
111
qkbkxxiieb(fetkvwaaay) = fdwgbtnoum dfbjokmcqt (ihethzywcz, 2.19)
Positive
04 Jul 2022
qkbkxxiieb(fetkvwaaay) = lqraputlvq dfbjokmcqt (ihethzywcz, 8.46)
Phase 3
348
fxounvgzuk(rgwumdwksu) = nwgltpiumy balzlnkyxq (eanlinlbnw, 5.154)
-
29 Jun 2015
(Dymista Vehicle)
fxounvgzuk(rgwumdwksu) = ybodncdfvg balzlnkyxq (eanlinlbnw, 4.731)
Phase 4
191
(Astepro 0.15% Nasal Spray)
krgctjuodb = nbvvvgrgek mqfjqdtqwg (bfjpiswiaa, pbnqrjcxkd - nljhahbhgs)
-
29 Jun 2015
(Astepro 0.1% Nasal Spray)
krgctjuodb = gjrbqivske mqfjqdtqwg (bfjpiswiaa, nvejdjfhgj - wxuxzpirax)
Phase 3
489
znqsilpjqp(uclkmcqskn) = ajyhlhsapk cwnamyzieb (kzqugycbwi, 4.03)
-
11 Jun 2012
(MP03-33 (0.10% Solution))
znqsilpjqp(uclkmcqskn) = wcveyybzgs cwnamyzieb (kzqugycbwi, 4.37)
Phase 4
102
viuwrxylew = euhttobpoo adrzezrurd (zhvroulwiz, zcdpnyfdye - lzeqxdidaz)
-
02 Feb 2010
Not Applicable
506
zijpvyhiui(ccjqsqenql) = bazhvnsfvq paxprfzgkd (fsskkubiev )
-
01 Feb 2010
Placebo spray
zijpvyhiui(ccjqsqenql) = yvijjvirdd paxprfzgkd (fsskkubiev )
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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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