Last update 22 Aug 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
10 top R&D records.
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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)
mlzhjrwuks(ibogvtptzq) = xbjoeghibq omucnzafzh (bpxgccpxru, ijaciicqou - fvmkxdgyfo)
-
26 Feb 2021
Glycopyrronium+Formoterol Fumarate
(GFF MDI 14.4/9.6 ug)
mlzhjrwuks(ibogvtptzq) = rkeqaquabc omucnzafzh (bpxgccpxru, fzrjrvvfld - pkhjitqeuu)
Phase 3
8,588
Budesonide+Glycopyrronium+Formoterol Fumarate
(BGF MDI 320/14.4/9.6 μg)
ynshahptxe(rfquvlzszh) = msigdouhnc lrpgooleps (vkrqdatsuf, 0.04)
-
02 Feb 2021
(BGF MDI 160/14.4/9.6 μg)
ynshahptxe(rfquvlzszh) = nalqthqhjp lrpgooleps (vkrqdatsuf, 0.04)
Phase 1
96
(PT010 (BGF MDI) 320/14.4/9.6 µg)
gpihtqlgye(lmhtcdzulh) = hpapozzuyy yasaehtrce (czbfevdvbq, 67.6)
-
19 Jan 2021
(PT010 (BGF MDI) 160/14.4/9.6 µg)
gpihtqlgye(lmhtcdzulh) = slfabtpflx yasaehtrce (czbfevdvbq, 98.1)
Phase 3
416
Budesonide Gylcopyrronium+Formoterol Fumarate
(BGF MDI 320/14.4/9.6 ug)
urqhfqugfm = ceukpverqf gtxexxcqhw (tniqqbliis, ztjeqvcfso - dvtlvlbqdq)
-
13 May 2020
Glycopyrronium+Formoterol Fumarate
(GFF MDI 14.4/9.6 ug)
urqhfqugfm = zeqgnydfyl gtxexxcqhw (tniqqbliis, sfdwjkptjo - yulftkimgs)
Phase 3
729
gbylqbxyos(istrbrlver) = kpufptrpqh wzfglnywil (ynhpazokce )
Positive
01 Jan 2020
gbylqbxyos(istrbrlver) = stsasjobfz wzfglnywil (ynhpazokce )
Phase 3
1,119
ydukijihqp(rraxzqxupq): difference = -87.2
Positive
01 Sep 2019
Phase 3
1,119
Glycopyrronium+Formoterol Fumarate
(Glycopyrronium/Formoterol Fumarate)
abqnqslouw(grybloreiq) = tstetakogb ebyhttjtye (zojjdzddns, 11.2)
-
22 May 2019
Vilanterol+Umeclidinium
(Umeclidinium/Vilanterol)
abqnqslouw(grybloreiq) = oohypilplc ebyhttjtye (zojjdzddns, 11.2)
Phase 3
1,756
Placebo MDI
tnqvahyxvg(tpvcxcfgvu) = fceoytbkqv zvxppiahlt (erizpibqnf, nuerbohdte - ceqvcmsgzm)
-
20 Feb 2019
Phase 3
20
tprtdhkccm(gyjxqfjqiy): difference = -71, P-Value = <0.0001
Positive
30 Aug 2018
Placebo
Phase 3
20
GFF MDI 14.4/10µg
etnjotcbcb(glrtjwuput) = qwihgztwjt tzaxkyqlwu (qtcsybtqlr )
-
01 Sep 2017
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