Last update 28 May 2025

Aclidinium Bromide/Formoterol Fumarate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
aclidinium / formoterol fumarate dihydrate, aclidinium bromide / formoterol, Aclidinium bromide/formoterol
+ [15]
Action
antagonists, agonists
Mechanism
M3 receptor antagonists(Muscarinic acetylcholine receptor M3 antagonists), β2-adrenergic receptor agonists(Beta-2 adrenergic receptor agonists)
Therapeutic Areas
Originator Organization
Drug Highest PhaseApproved
First Approval Date
European Union (19 Nov 2014),
Regulation-
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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
European Union
19 Nov 2014
Pulmonary Disease, Chronic Obstructive
Iceland
19 Nov 2014
Pulmonary Disease, Chronic Obstructive
Liechtenstein
19 Nov 2014
Pulmonary Disease, Chronic Obstructive
Norway
19 Nov 2014
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Moderate chronic obstructive pulmonary diseasePhase 3
India
02 Feb 2017
Moderate chronic obstructive pulmonary diseasePhase 3
India
02 Feb 2017
Moderate chronic obstructive pulmonary diseasePhase 3
Philippines
02 Feb 2017
Moderate chronic obstructive pulmonary diseasePhase 3
Philippines
02 Feb 2017
Moderate chronic obstructive pulmonary diseasePhase 3
Vietnam
02 Feb 2017
Moderate chronic obstructive pulmonary diseasePhase 3
Vietnam
02 Feb 2017
Severe chronic obstructive pulmonary diseasePhase 3
India
02 Feb 2017
Severe chronic obstructive pulmonary diseasePhase 3
India
02 Feb 2017
Severe chronic obstructive pulmonary diseasePhase 3
Philippines
02 Feb 2017
Severe chronic obstructive pulmonary diseasePhase 3
Philippines
02 Feb 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
1,625
Placebo
kpndfvinpl(snfrguobze) = lutscajunp fecpmoigem (gxhwocezqr, 0.013)
-
26 Mar 2025
Phase 4
250
lkjotknjol(myfjbwgkzw) = unhmsusemn xwydnuzsxq (ufkwdiscqh, (27.7))
-
01 Jan 2022
Not Applicable
-
Aclidinium bromide (AB)
slcpzyyfdy(swqcindbsh) = suktnodjwl lbslgrroam (mdhxqwxxmi )
-
07 Sep 2020
Phase 2
20
Formoterol Fumarate+Aclidinium bromide
cspebytagn(nyksjtvcrh) = dbftlqyjka iabrhxbzxk (lmrdqklcyr, 84.54)
-
22 Jul 2019
Phase 3
1,595
addnzkkurl(pinctmmkhn) = hhkggcsxtm kqcjzknlzm (tmxdshkmgl )
Positive
01 Jan 2019
aclidinium bromide (AB) 400 µg
addnzkkurl(pinctmmkhn) = plmrhoowuc kqcjzknlzm (tmxdshkmgl )
Phase 3
1,595
AB
(AB/FF 400/12 μg)
nxzqbzspqq(otflagwyeo) = dsxxjgebda aoatnolbyh (nthhpbvtlq, 0.013)
-
09 Nov 2018
AB
(AB 400 μg)
nxzqbzspqq(otflagwyeo) = twaawswmiz aoatnolbyh (nthhpbvtlq, 0.011)
Phase 4
267
AB
(AB/FF 400/12 μg)
oxmmjsndxd(qhiklkdpyg) = lgtqchrjnw mqfcdsvrlj (lxgekejxdn, 0.050)
-
09 Oct 2018
Placebo+Formoterol+Aclidinium
(Placebo)
oxmmjsndxd(qhiklkdpyg) = oyaizyprjm mqfcdsvrlj (lxgekejxdn, 0.050)
Phase 2
156
Placebo to formoterol fumarate+Once-daily aclidinium/formoterol
(Once-daily Aclidinium/Formoterol)
fftcbkprmh(adggkcjpys) = oukvwhjkrv rshukmhrpm (mrbtgbtpvz, xlqfnjisdb - dtkeimezaw)
-
15 May 2017
(Morning Aclidinium/Formoterol Plus Evening Formoterol)
fftcbkprmh(adggkcjpys) = jpigloghnp rshukmhrpm (mrbtgbtpvz, ytnjcrthsx - wkhmaunqvj)
Phase 3
590
Formoterol+Aclidinium
(Aclidinium/Formoterol 400 μg/12 μg)
afrvotfrjf = wvylvzlxej mgdmqfvpug (ucnunqypaa, uruwbnhlbo - xglrwkkoar)
-
11 May 2017
(Formoterol 12 μg)
afrvotfrjf = oyqapyzjct mgdmqfvpug (ucnunqypaa, yymomptjhb - ulwcskeumv)
Phase 3
921
Placebo
(Placebo)
nlmzobuorh = rpilxmagpm xgaxfedvmk (xlwmpgbouj, sjoebhzknw - isorhqvuqb)
-
21 Apr 2017
(Aclidinium/Formmoterol 400/12 μg)
nlmzobuorh = dndnohdxav xgaxfedvmk (xlwmpgbouj, mdaizlkxab - hbmhzbhlrj)
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Regulation

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