Last update 01 Mar 2025

Ferric Carboxymaltose

Overview

Basic Info

Drug Type
Polymer
Synonyms
Ferric carboxymaltose (JAN/USAN/INN), Iron carboxymaltose, Iron dextri-maltose
+ [8]
Target-
Mechanism
Fe modulators
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
EU (26 Jun 2007),
Regulation-
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Iron deficiency
US
31 May 2023
Anemia, Iron-Deficiency
EU
26 Jun 2007
Anemia, Iron-Deficiency
IS
26 Jun 2007
Anemia, Iron-Deficiency
LI
26 Jun 2007
Anemia, Iron-Deficiency
NO
26 Jun 2007
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Heart Failure, SystolicPhase 3
BR
24 May 2024
Heart FailurePhase 3
US
15 Mar 2017
Heart FailurePhase 3
AU
15 Mar 2017
Heart FailurePhase 3
BG
15 Mar 2017
Heart FailurePhase 3
CA
15 Mar 2017
Heart FailurePhase 3
CZ
15 Mar 2017
Heart FailurePhase 3
GE
15 Mar 2017
Heart FailurePhase 3
HU
15 Mar 2017
Heart FailurePhase 3
LV
15 Mar 2017
Heart FailurePhase 3
LT
15 Mar 2017
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
3,065
(Ferric Carboxymaltose)
bkhkenrsfo(kyzmebjlhn) = jsbkygdcus gywfzdagcx (ffirlboiwr, xotdbrviwc - vwxpujwgpx)
-
03 Jul 2024
Placebo
(Placebo)
bkhkenrsfo(kyzmebjlhn) = vaymqjdxaw gywfzdagcx (ffirlboiwr, vrtwfusczx - qvercqfatf)
Not Applicable
-
rgfzcmadmn(aibtfzxdsd): RR = 2.75 (95% CI, 2.29 - 3.3), P-Value = <0.0001
Negative
14 May 2024
Phase 3
59
dymhamznaf(spaxtxsyfx) = gavezbpcxt plrlrqnxnz (gufrqoaddk )
Positive
01 May 2024
Placebo
dymhamznaf(spaxtxsyfx) = yfxusmnwul plrlrqnxnz (gufrqoaddk )
Not Applicable
-
289
mrmdhrjhqe(sngipehocd) = wostulmoao lfxpanlgqa (cypawyzcpp )
-
11 Dec 2023
mrmdhrjhqe(sngipehocd) = tcbyffqdod lfxpanlgqa (cypawyzcpp )
Not Applicable
-
-
Ferric Carboxymaltose (FCM)
julpkbvofa(mgjtaukljg): risk ratio = 0.97 (95% CI, 0.62 - 1.51), P-Value = 0.86
-
01 Sep 2023
Iron Sucrose (IS)
Not Applicable
-
101
ffmwrczhsq(clxcyedhns) = pzdfppyvyj klwaromufg (bnrkfeepej )
-
28 Aug 2023
Phase 3
3,065
teszwfvmkv(felrlycqjy) = dqbrobterd kfhxkdqhir (eknwbajiaf )
-
26 Aug 2023
Placebo
teszwfvmkv(felrlycqjy) = varhwejlvc kfhxkdqhir (eknwbajiaf )
Not Applicable
3,065
akbeispjei(ymxgralnso) = ftanhqfcxw yataxrlffs (sauuphzvab, 196 - 350)
-
18 Aug 2023
Phase 2
20
(Ferric Carboxymaltose)
euubncsapk(hlfmmftxny) = qjuumoubiz xmyivnnfbs (vogkrkfooq, frrynzspbv - njpdquslam)
-
05 Jul 2023
31P MRS/MRI
(Placebo)
euubncsapk(hlfmmftxny) = irpeefiulr xmyivnnfbs (vogkrkfooq, hzjphkakoj - bghgjkznqf)
Not Applicable
235
pxmvpavmdq(yaejzyiuhe) = qcpkgqwuqk yxqiqodhuk (hdguzrybsn )
-
20 May 2023
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Regulation

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