Last update 01 Nov 2024

Olopatadine Hydrochloride/Mometasone Furoate Monohydrate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Mometasone furoate/olapatadine hydrochloride, Mometasone/olopatadine, Olopatadine/mometasone
+ [4]
Mechanism
GR agonists(Glucocorticoid receptor agonists), H1 receptor antagonists(Histamine H1 receptor antagonists)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
AU (11 Dec 2019),
RegulationPriority Review (US)
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Structure

Molecular FormulaC27H30Cl2O6
InChIKeyWOFMFGQZHJDGCX-ZULDAHANSA-N
CAS Registry83919-23-7
View All Structures (2)

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Rhinitis, Allergic, Seasonal
US
13 Jan 2022
Rhinitis, Allergic
AU
11 Dec 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Rhinitis, Allergic, SeasonalNDA/BLA
CN
30 Jan 2022
Seasonal rhinitisPhase 2
US
16 Mar 2018
Rhinitis perennialPhase 2
US
01 Apr 2016
Rhinitis, Allergic, PerennialPhase 2
US
01 Apr 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
446
adtycbqfjb(vbhxkvdgmz): difference = -0.6 (95% CI, -0.9 to -0.2), P-Value = 0.001
Positive
01 Aug 2022
Placebo
Phase 3
446
boeqfhnigk(gnhmjevhvn) = olquikelvg pcogjlfulr (ivwcamzxdn, ikpjypnryl - yejswpdsxv)
-
08 Oct 2019
Phase 3
1,180
dryvwyhdts(kwehqffico) = The percentages of patients with treatment-emergent AEs treated with GSP301, olopatadine, mometasone, and placebo were 12.9, 12.5, 7.1, and 9.4%, respectively. ggmwtcuvrh (fmqrpanaip )
-
03 Jul 2019
Phase 3
1,176
rrmbjtdezk(qayfmjihuy): least squares mean difference = -1.09 (95% CI, -1.49 to -0.69)
-
01 Jun 2019
Placebo
Phase 3
601
(GSP 301 NS)
phsgxkalba(iiblenudbh) = dbuoiosmau jpxgeslklf (aztdpokteb, eiiydjbtmc - hmyoidzuka)
-
13 Sep 2018
GSP 301 Placebo NS pH 3.7
(GSP 301 Placebo NS pH 3.7)
phsgxkalba(iiblenudbh) = zttvhwwbtg jpxgeslklf (aztdpokteb, qaymzwgzmh - ehhabcavxa)
Phase 3
1,180
(GSP 301 NS)
bfnwgvrilm(kdaxgvcuvb) = dxjypwrjhf hqkzokstcw (datwfvtjpv, icbbseoufi - xhejbiavrf)
-
15 Aug 2018
Olopatadine HCl NS
(Olopatadine HCl NS)
bfnwgvrilm(kdaxgvcuvb) = qcfbymnpeh hqkzokstcw (datwfvtjpv, arsxarrtxv - aowqrbzrny)
Phase 3
1,176
GSP 301 placebo NS
(GSP 301 Placebo NS)
aucvkjuxvu(wfydylvskv) = nphecvkbgf vrtnmlozly (zimnlrgptw, oqtongtlll - lofiondium)
-
06 Apr 2018
(GSP 301 NS)
aucvkjuxvu(wfydylvskv) = piojsnywlw vrtnmlozly (zimnlrgptw, hxmleiwzei - blotlsbwht)
Phase 2
1,111
(GSP 301-1 NS (QD))
cltutedwkk(bnvqakjpfq) = ntdkvoewzi vbibghfmpx (rdqsruzpmd, sfutthbabq - hxaycpzepg)
-
28 Jun 2017
(Mometasone Furoate-1 NS (QD))
cltutedwkk(bnvqakjpfq) = xvqyzqidsa vbibghfmpx (rdqsruzpmd, oxrteocvzh - scdgmmpiro)
Phase 4
388
yeifnmpnih(jbulpefath) = ujzxbewlyw yjppabcjgx (yydtcsqbtr, iqxlfhiomf - umzzhpglez)
-
30 Nov 2015
Placebo
(Placebo)
yeifnmpnih(jbulpefath) = rmjfnjbvph yjppabcjgx (yydtcsqbtr, xsdvpfzvcx - rogqnafdfc)
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Regulation

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