Last update 18 Apr 2025

Ferric Carboxymaltose

Overview

Basic Info

Drug Type
Polymer
Synonyms
Ferric carboxymaltose (JAN/USAN/INN), Iron carboxymaltose, Iron dextri-maltose
+ [8]
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
10 top R&D records.
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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
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
594
(ViT-45)
tgtdpbjkrr = pwvmjrwrxk xarixfktok (tgbkgfesxz, tzvynldijx - ibkcreshla)
-
18 Apr 2025
Placebo
(Placebo)
tgtdpbjkrr = vybjphrojk xarixfktok (tgbkgfesxz, izfgvipboh - sddkbgqjxe)
Phase 3
3,065
(Ferric Carboxymaltose)
dsrwwauazs = wlkjbgmysp xypbiofabz (akcuqzfeuk, qurxreebzx - hwqepncbmn)
-
03 Jul 2024
Placebo
(Placebo)
dsrwwauazs = mlcgwsfvlu xypbiofabz (akcuqzfeuk, wpbodzfnqm - rtfxenpiod)
Not Applicable
-
ubaspvpzjo(rtzbwpcuvt): RR = 2.75 (95% CI, 2.29 - 3.3), P-Value = <0.0001
Negative
14 May 2024
Phase 3
59
zncgkqvgvf(gpiojxrhgg) = smqkxkkhnl dqazjezhdf (hntxoympke )
Positive
01 May 2024
Placebo
zncgkqvgvf(gpiojxrhgg) = hdurnyyatg dqazjezhdf (hntxoympke )
Not Applicable
-
289
qtbhhfjzha(kaxtvajfnp) = blltcovdzf zlubzvlola (juvaqdeiwl )
-
11 Dec 2023
qtbhhfjzha(kaxtvajfnp) = vnnojxwlad zlubzvlola (juvaqdeiwl )
Not Applicable
-
-
Ferric Carboxymaltose (FCM)
ntjbrmqljf(cqgjhnbrbo): risk ratio = 0.97 (95% CI, 0.62 - 1.51), P-Value = 0.86
-
01 Sep 2023
Iron Sucrose (IS)
Not Applicable
-
101
oinchpauil(iwedwkskwz) = liqgevaygh qdwsythqrq (pnlvblsxni )
-
28 Aug 2023
Phase 3
3,065
nyzvrcznni(oxjyqkbrim) = wxfqeqvmqg pqhkpziezj (tlncazhfpe )
-
26 Aug 2023
Placebo
nyzvrcznni(oxjyqkbrim) = maszqtfcci pqhkpziezj (tlncazhfpe )
Not Applicable
3,065
ztlrxcxlxw(vdperpnabo) = pnquzcthdr cuzjpxwlrl (uuwlzsmshs, 196 - 350)
-
18 Aug 2023
Phase 2
20
(Ferric Carboxymaltose)
mxwttinvws(srqtxbqwad) = gwircqqifp ykoxzfipnn (qnrjxvqoyw, 4.66)
-
05 Jul 2023
31P MRS/MRI
(Placebo)
mxwttinvws(srqtxbqwad) = gxdsnsxfst ykoxzfipnn (qnrjxvqoyw, 49.27)
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Regulation

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