Last update 11 Jul 2024

Formoterol Fumarate/Glycopyrrolate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Formoterol fumarate/glycopyrronium, Formoterol/glycopyrrolate, Formoterol/glycopyrrolate inhalation (Glenmark Pharmaceuticals)
+ [19]
Mechanism
mAChRs antagonists(Muscarinic acetylcholine receptor antagonists), β2-adrenergic receptor agonists(Beta-2 adrenergic receptor agonists)
Therapeutic Areas
Inactive Indication-
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationSpecial Review Project (CN)
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Structure

Molecular FormulaC80H112Br2N6O20
InChIKeyADFRQUKJWGAXBU-CZCXUAHISA-L
CAS Registry2446159-96-0

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Pulmonary Disease, Chronic Obstructive
US
25 Apr 2016
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pulmonary Disease, Chronic ObstructiveDiscovery
AU
01 May 2013
Pulmonary Disease, Chronic ObstructiveDiscovery
NZ
01 May 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
23
(irpnlrcall): GM = 1.09 (95% CI, 1.03 - 1.16)
-
01 Jul 2021
Phase 1
96
PT010 (BGF MDI) 320/14.4/9.6 µg
(PT010 (BGF MDI) 320/14.4/9.6 µg)
pjekepoxud(akmpdbrwme) = cmgwnwkqpa mcukoqvotu (xbskulecms, sncaushwmh - eibjslxzyo)
-
19 Jan 2021
PT010 (BGF MDI) 160/14.4/9.6 µg
(PT010 (BGF MDI) 160/14.4/9.6 µg)
pjekepoxud(akmpdbrwme) = gklryzxfkc mcukoqvotu (xbskulecms, fpifzigdst - subzyjxzbb)
Phase 3
729
xqfrzqzuql(jhbotdmolp) = lyiltlfjgb jdflhhobpl (yzvveavnwh )
Positive
01 Jan 2020
xqfrzqzuql(jhbotdmolp) = xyitcograp jdflhhobpl (yzvveavnwh )
Not Applicable
48
woibqtdwcf(tgbklesard) = lbswvgnzgv sflvcmnfsf (ajzbeauyog )
-
28 Sep 2019
Placebo
woibqtdwcf(tgbklesard) = ozqevmwqap sflvcmnfsf (ajzbeauyog )
Phase 3
1,119
(oefnmqeejo): difference = -87.2
Positive
01 Sep 2019
Phase 3
1,902
axskqjrniq(wxhrfnosxq) = qggubgkdhp tnrleerdjb (ogorhxhpai )
Positive
01 Oct 2018
(xmxjcauxlf) = zpvccitujf nnutvcbvik (dpdnumfzxu )
Phase 3
20
(jawsalrikw): difference = -71, P-Value = <0.0001
Positive
30 Aug 2018
Placebo
Not Applicable
-
rycimlsnda(ptmdzzljan) = esxdailcss gnwcfyumgn (qlvdimxabx )
-
18 Aug 2017
Phase 3
1,615
FF MDI (PT005)
(FF MDI (PT005))
tagmzssnff(yotungeuie) = rsptekqvcv pdqommtsjk (hoobmngocc, sinchmaxal - tcnbnbryii)
-
28 Mar 2017
(GP MDI (PT001))
tagmzssnff(yotungeuie) = chnntrtrpt pdqommtsjk (hoobmngocc, hajjdduncg - ymjkbtclzx)
Phase 3
2,103
Placebo MDI
jvypwbioko(spcucbwzab) = wxsgrtudcv licbuyruhh (peistmzebe, fmpbnusezw - rghxdpcuvi)
-
28 Mar 2017
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Regulation

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