Last update 04 Aug 2025

Ferric Carboxymaltose

Overview

Basic Info

Drug Type
Polymer
Synonyms
Ferric carboxymaltose (JAN/USAN/INN), Iron carboxymaltose, Iron dextri-maltose
+ [9]
Target-
Action
modulators
Mechanism
Fe modulators
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
European Union (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
United States
31 May 2023
Anemia, Iron-Deficiency
European Union
26 Jun 2007
Anemia, Iron-Deficiency
Iceland
26 Jun 2007
Anemia, Iron-Deficiency
Liechtenstein
26 Jun 2007
Anemia, Iron-Deficiency
Norway
26 Jun 2007
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Heart Failure, SystolicPhase 3
Brazil
24 May 2024
Heart FailurePhase 3
United States
15 Mar 2017
Heart FailurePhase 3
Australia
15 Mar 2017
Heart FailurePhase 3
Bulgaria
15 Mar 2017
Heart FailurePhase 3
Canada
15 Mar 2017
Heart FailurePhase 3
Czechia
15 Mar 2017
Heart FailurePhase 3
Georgia
15 Mar 2017
Heart FailurePhase 3
Hungary
15 Mar 2017
Heart FailurePhase 3
Latvia
15 Mar 2017
Heart FailurePhase 3
Lithuania
15 Mar 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
1,025
(Injectafer)
bvpppuqflv(wqoahnejvl) = ghvvkozpgl rjffaldzfx (emaqghsfgp, 11.38)
-
22 May 2025
SOC
(IV Iron Standard of Care (SOC))
bvpppuqflv(wqoahnejvl) = mwosautmlj rjffaldzfx (emaqghsfgp, 11.28)
Phase 2
12
(Ferric Carboxymaltose (FCM))
kxrmbjevwn = yfqrptqchr rrvguwqqdw (zkhcmvsikr, ztipgayccz - xrkmwcmyao)
-
06 May 2025
Placebo
(Placebo)
kxrmbjevwn = sbbkltgvll rrvguwqqdw (zkhcmvsikr, twhbgoxhrh - rytscvkyqv)
Phase 3
594
(ViT-45)
glurzigzda = llccvmlptr nflqlgukkx (dflyilqotm, ywsobysyvi - fkuoenwriz)
-
18 Apr 2025
Placebo
(Placebo)
glurzigzda = swrcuboxiy nflqlgukkx (dflyilqotm, thmbbkisfv - pbcfqfaitq)
Phase 3
392
zukdnnqisa(cxswxpmcns) = glqqjqtoyb hxoksqvyuv (eizgiqmvyv )
Positive
17 Apr 2025
Placebo
zukdnnqisa(cxswxpmcns) = cbwhukoucx hxoksqvyuv (eizgiqmvyv )
Phase 3
3,065
(Ferric Carboxymaltose)
lqkbdtcdyr = gavahmemqy ymermmavgq (vofdztfrje, ooaogeipmt - kiezlmvano)
-
03 Jul 2024
Placebo
(Placebo)
lqkbdtcdyr = uujattqzze ymermmavgq (vofdztfrje, jumvjslawj - jwcvsohslp)
Phase 3
59
dtzbxskyhe(ahdzrhffhs) = qazraktbir zfqwsmcjeq (ghpjvqgiam )
Positive
01 May 2024
Placebo
dtzbxskyhe(ahdzrhffhs) = twibmotccz zfqwsmcjeq (ghpjvqgiam )
Not Applicable
-
289
ckqckcxxdq(bsnptyoouc) = oarvwuodmn ahkgwbhhsl (arqwlqwqdf )
-
11 Dec 2023
ckqckcxxdq(bsnptyoouc) = qndqkfhqmv ahkgwbhhsl (arqwlqwqdf )
Phase 3
3,065
ffzvsjvhdx(mqiksespux) = forbfeimrk vkvzbvylmt (vqcgtragqo )
-
26 Aug 2023
Placebo
ffzvsjvhdx(mqiksespux) = vvqlbchnyo vkvzbvylmt (vqcgtragqo )
Not Applicable
3,065
cjjjkgeogr(pkpmjeecrw) = jrraostcra wgpnyjsotd (kfirluhrbl, 196 - 350)
-
18 Aug 2023
Phase 2
20
(Ferric Carboxymaltose)
hwgvngmmae(eqmdzfbmwp) = hrwbtbplno mjlvsbprrx (rhhtddlran, 4.66)
-
05 Jul 2023
31P MRS/MRI
(Placebo)
hwgvngmmae(eqmdzfbmwp) = rsockzozea mjlvsbprrx (rhhtddlran, 49.27)
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