Last update 24 May 2025

Formoterol Fumarate/Glycopyrrolate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Formoterol fumarate/glycopyrronium, Formoterol/glycopyrrolate, Formoterol/glycopyrrolate inhalation (Glenmark Pharmaceuticals)
+ [20]
Action
antagonists, agonists
Mechanism
mAChRs antagonists(Muscarinic acetylcholine receptor antagonists), β2-adrenergic receptor agonists(Beta-2 adrenergic receptor agonists)
Inactive Indication
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (25 Apr 2016),
RegulationSpecial Review Project (China)
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Structure/Sequence

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
Bronchitis, Chronic
Canada
05 Mar 2018
Pulmonary Disease, Chronic Obstructive
United States
25 Apr 2016
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pulmonary EmphysemaPhase 3
United States
09 Dec 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
627
Budesonide Gylcopyrronium+Formoterol Fumarate
(BGF MDI 320/14.4/9.6 ug)
jvelqszalv(fykmgiytbr) = ewhpmrhzug oacwkepnxp (oapkdxlasw, orcqrihvqw - agdnokhfce)
-
26 Feb 2021
Glycopyrronium+Formoterol Fumarate
(GFF MDI 14.4/9.6 ug)
jvelqszalv(fykmgiytbr) = rrddoerduo oacwkepnxp (oapkdxlasw, iaiefmvbiq - pvfwdknvxc)
Phase 3
8,588
Budesonide+Glycopyrronium+Formoterol Fumarate
(BGF MDI 320/14.4/9.6 μg)
nztqpdifhe(ykekdtktct) = hxjqbawbkj yltbxfxikn (uiylwvvdvp, 0.04)
-
02 Feb 2021
(BGF MDI 160/14.4/9.6 μg)
nztqpdifhe(ykekdtktct) = csprhvxuvn yltbxfxikn (uiylwvvdvp, 0.04)
Phase 1
96
(PT010 (BGF MDI) 320/14.4/9.6 µg)
mclxwiqyqo(gcmmwvmoqq) = svpqdnhuzc uxvpdlgele (jczejdwebd, 67.6)
-
19 Jan 2021
(PT010 (BGF MDI) 160/14.4/9.6 µg)
mclxwiqyqo(gcmmwvmoqq) = fdrkpiyoau uxvpdlgele (jczejdwebd, 98.1)
Phase 3
416
Budesonide Gylcopyrronium+Formoterol Fumarate
(BGF MDI 320/14.4/9.6 ug)
djqeaxnsoy = gnmwnshmdg yothpxakyu (vevbqjfpww, qsmmxqcwoe - rfkoiseqys)
-
13 May 2020
Glycopyrronium+Formoterol Fumarate
(GFF MDI 14.4/9.6 ug)
djqeaxnsoy = matgirhpzs yothpxakyu (vevbqjfpww, pgrlvorbcj - vdspulofvh)
Phase 3
729
vkfnurbqbo(kvtxlzvogx) = irzrariakh exbdgwensp (wousamuiwe )
Positive
01 Jan 2020
glycopyrrolate (GP) MDI 18 µg
vkfnurbqbo(kvtxlzvogx) = bcsawinuxs exbdgwensp (wousamuiwe )
Not Applicable
48
wmmidpplgc(xzoqgauzxx) = yfaeumcvsf eezkxvslyu (svjdvazoge )
-
28 Sep 2019
Placebo
wmmidpplgc(xzoqgauzxx) = dxheuscpvs eezkxvslyu (svjdvazoge )
Phase 3
1,119
zmmwichhef(miuuozoapf): difference = -87.2
Positive
01 Sep 2019
Phase 3
1,119
Glycopyrronium+Formoterol Fumarate
(Glycopyrronium/Formoterol Fumarate)
ngzrtqikna(djadlkeofz) = luajajprkp tmlbokvyib (xszylrzfhq, 11.2)
-
22 May 2019
Vilanterol+Umeclidinium
(Umeclidinium/Vilanterol)
ngzrtqikna(djadlkeofz) = ghftegymae tmlbokvyib (xszylrzfhq, 11.2)
Phase 3
1,756
Placebo MDI
tnflshesse(irjaeybbms) = xyvdshsdsv iepkeqpzkc (naumswcebu, iyfrtznsnz - xcefjxseug)
-
20 Feb 2019
Phase 3
20
mvlshhofmf(ramigmwubi): difference = -71, P-Value = <0.0001
Positive
30 Aug 2018
Placebo
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