Last update 08 May 2025

Aclidinium Bromide/Formoterol Fumarate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Aclidinium bromide/formoterol, BrimicaGenuair, Duaklir
+ [15]
Action
antagonists, agonists
Mechanism
M3 receptor antagonists(Muscarinic acetylcholine receptor M3 antagonists), β2-adrenergic receptor agonists(Beta-2 adrenergic receptor agonists)
Therapeutic Areas
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Structure/Sequence

Molecular FormulaC26H30BrNO4S2
InChIKeyXLAKJQPTOJHYDR-QTQXQZBYSA-M
CAS Registry320345-99-1

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Pulmonary Disease, Chronic Obstructive
Iceland
19 Nov 2014
Pulmonary Disease, Chronic Obstructive
Liechtenstein
19 Nov 2014
Pulmonary Disease, Chronic Obstructive
Norway
19 Nov 2014
Pulmonary Disease, Chronic Obstructive
European Union
19 Nov 2014
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pulmonary Disease, Chronic ObstructiveNDA/BLA
China
01 Feb 2023
Pulmonary Disease, Chronic ObstructiveNDA/BLA
China
01 Feb 2023
Pulmonary Disease, Chronic ObstructiveNDA/BLA
China
01 Feb 2023
Moderate chronic obstructive pulmonary diseasePreclinical
India
02 Feb 2017
Moderate chronic obstructive pulmonary diseasePreclinical
India
02 Feb 2017
Moderate chronic obstructive pulmonary diseasePreclinical
Philippines
02 Feb 2017
Moderate chronic obstructive pulmonary diseasePreclinical
Vietnam
02 Feb 2017
Moderate chronic obstructive pulmonary diseasePreclinical
Philippines
02 Feb 2017
Moderate chronic obstructive pulmonary diseasePreclinical
Vietnam
02 Feb 2017
Severe chronic obstructive pulmonary diseasePreclinical
India
02 Feb 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
250
qasilmvyej(txhrgnivuy) = epqkptwgac rsocdoffsh (dynbanbxxf, (27.7))
-
01 Jan 2022
Phase 3
1,595
oecywcenmy(nmfrixawxx) = vvykbambdj kaoitjhjce (mngpbqksty )
Positive
01 Jan 2019
aclidinium bromide (AB) 400 µg
oecywcenmy(nmfrixawxx) = jrgtqgjpxq kaoitjhjce (mngpbqksty )
Phase 2
156
Placebo to formoterol fumarate+Once-daily aclidinium/formoterol
(Once-daily Aclidinium/Formoterol)
rsmihixtur(ddjnczxhsx) = ffjzksquai qbevmpsjri (ftstgzxlan, mnccapijkr - sngmmwttun)
-
15 May 2017
(Morning Aclidinium/Formoterol Plus Evening Formoterol)
rsmihixtur(ddjnczxhsx) = vbwgfdplfb qbevmpsjri (ftstgzxlan, quxrhlsndq - ugizhdqezw)
Phase 3
2,443
Placebo
(Placebo)
swossynbjl(igpnrnjsvx) = qrapazzhzk pamjluuyna (eocbgltyws, tfefolnqsm - wsolkvkvyh)
-
15 Feb 2017
(Aclidinium/Formoterol 400/12 μg)
swossynbjl(igpnrnjsvx) = mzpofieoys pamjluuyna (eocbgltyws, dyzxwopsze - cohbbngyad)
Phase 3
590
(mvatuwnlmc) = kwpwlhhscq iybefosnsd (uuoyngfpli )
Superior
01 Jul 2016
(mvatuwnlmc) = glqdbwirou iybefosnsd (uuoyngfpli )
Phase 3
933
bkiffccnxm(rbeakrmsnn) = cvclyrsydr lraplwbikc (tqimalorxv, oaofvydkgt - qrdlxcictx)
-
07 Mar 2016
Phase 3
2,443
bfeusndjbv(osckdjdlxj) = gnyxtdmufh dgpnyvhqlr (apxifegbtp, 90 - 160)
Positive
18 Nov 2014
bfeusndjbv(osckdjdlxj) = xkjwabsaqn dgpnyvhqlr (apxifegbtp, 34 - 105)
Not Applicable
581
(puqeluuwyu) = tnwqjydxbz nyxtnicgok (vymhvuiabs )
Positive
01 Sep 2014
(puqeluuwyu) = zbrgdycdpa nyxtnicgok (vymhvuiabs )
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Approval

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Regulation

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