Drug ID:Drug182
Drug Name:Ferric carboxymaltose
CID:139266768
DrugBank ID:DB08917
Modality:Small Molecule
Groups:approved
US Approved:YES
Other Approved:YES
Identifier: NCT02517151, , NCT04587141, , NCT00810030
Molecular Formula:C24H44FeO25-
Molecular Weight:788.4 g/mol
Isomeric SMILES:C(C1C(C(C(C(O1)OC2C(OC(C(C2O)O)OC3C(OC(C(C3O)O)OC(C(CO)O)C(C(C(=O)[O-])O)O)CO)CO)O)O)O)O.O.[OH-].[O-2].[Fe+3]
Synonyms:Ferric carboxymaltose; 9007-72-1; Injectafer; Injectafer;Iron Dextri-Maltose; BCP30646
Phase 0: 0
Phase 1: 7
Phase 2: 18
Phase 3: 51
Phase 4: 59
Description:Ferric Carboxymaltose is an iron replacement product and chemically, an iron carbohydrate complex. FDA approved on July 25, 2013.

Molecular Structure

2D Molecular Structure

Knowledge Graph

dtIDCIDCompound NameGene IDGene NameSpeciesPubMed IDsAction
No data available

  • No data available

Phase Distribution
Phase Description
  • Phase 0: Exploratory trials to assess drug behavior in humans
  • Phase 1: Safety trials to determine safe dosage range
  • Phase 2: Efficacy trials to evaluate therapeutic effects
  • Phase 3: Large-scale trials to confirm efficacy and safety
  • Phase 4: Post-marketing surveillance for long-term safety and efficacy

Trial IDTitlePhaseStatusSponsorIndicationsInterventions
NCT00810030 FERINJECT for Correction of Anaemia in IBD Patients, FER-IBD-COR PHASE3 COMPLETED Vifor Pharma Inflammatory Bowel Disease|Anemia|Iron Deficiency… DRUG: Ferric carboxymaltose|DRUG: Iron Sucrose Details
NCT02517151 Iron Supplementation in Inflammatory Bowel Disease (IBD) Patients With Chronic Fatigue PHASE2 UNKNOWN Istituto Clinico Humanitas Chronic Fatigue|Inflammatory Bowel Disease DRUG: Ferric carboxymaltose|DRUG: Placebo Details
EUCTR2022-000894-16-NL Predicting Response to Iron Supplementation in Patients with active Inflammatory Bowel Disease_ - PRIme PHASE4 Not Recruiting Leiden University Medical Center Inflammatory Bowel Disease MedDRA version: 20.0_… Trade Name: Feraccru Pharmaceutical Form: Capsule… Details
NCT03466983 A Randomized, Double-blinded, Comparative Trial Comparing the Incidence of Hypophosphatemia in Relation to Repeated Treatment Courses of Iron Isomaltoside and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia Due to Inflammatory Bowel Disease PHASE4 Not recruiting Pharmacosmos A/S IBD Drug: Iron Isomaltoside;Drug: Ferric Carboxymalto… Details
EUCTR2012-005644-26-BE Prospective Open Label study of Parenteral vs Enteral iron in Young IBD patients and Effect on physical fitness - POPEYE study PHASE4 Authorised Atrium Medical Centre Anemia and fatigue in children with Inflammatory … Trade Name: Injectafer /ferinject. Pharmaceutical… Details
EUCTR2017-002452-87-GB A randomized, double-blinded, comparative trial comparing the incidence of hypophosphatemia in relation to repeated treatment courses of iron isomaltoside and ferric carboxymaltose in subjects with iron deficiency anaemia due to inflammatory bowel disease - hypophosphatemia following IV iron therapy in IDA due to IBD PHASE4 Not Recruiting Pharmacosmos A/S Iron deficiency anaemia due to inflammatory bowel… Trade Name: Monofer 100mg/ml Product Name: Monofe… Details
EUCTR2015-002496-26-DE A phase 3b, randomized, controlled, multicentre study with oral ferric maltol (Feraccru) or intravenous iron (ferric carboxymaltose; FCM), for the treatment of iron deficiency anaemia in subjects with inflammatory bowel disease - ST10 versus IV iron for IDA in IBD PHASE3 Not Recruiting Shield TX (UK) Ltd. Iron deficiency anaemia with inflammatory bowel d… Trade Name: Feraccru Product Name… Details
EUCTR2011-004561-33-AT A randomized, controlled, single-blinded, phase II study to investigate the safety and efficacy of intravenous infusions of FERINJECT versus placebo on platelet activity in patients with iron deficiency and chronic inflammatory bowel disease. The ThromboAct trial - ThromboAct PHASE2 Not Recruiting Medizinische Universit Wien, Klinik f Innere Medizin III, Abteilung f Gastroenterologie und Hepatologie iron deficiency in chronic inflammatory bowel dis… Trade Name: Ferinject Product Name: Ferinject Pha… Details
EUCTR2012-005644-26-NL Administration of intranvenous ferric carboxymaltose to children with IBD - AFCI Not Available Authorised Atrium Medical Centre Anemia in children with Inflammatory Bowel Diseas… Trade Name: Ferinject Product Name: ferinject Pha… Details
ACTRN12613000751774 In children with inflammatory bowel disease and iron deficiency, does intravenous iron therapy with Ferric Carboxymaltose signficantly improve cognitive function, quality of life and iron status. PHASE4 Not Recruiting Gastroenterology Department, Royal Children's Hospital - Brisbane Paediatric Inflammatory Bowel Disease;Iron defici… In Inflammatory bowel disease patients with iron … Details
NCT00882414 A Multi-centre, Randomized, Controlled, Single-blinded, Phase II Study to Investigate the Safety and Efficacy of Intravenous Infusions of FERINJECT Versus Placebo in Patients With Thrombocytosis Secondary to Iron Deficiency and Chronic Inflammatory Bowel Disease PHASE2 Not recruiting Vifor Inc. Thrombocytosis;Iron-Deficiency Anemia Drug: FERINJECT (Ferric carboxymaltose);Drug: Pla… Details
NCT00810004 A Multi-centre, Randomised, Prospective, Single-blinded, Controlled Study to Investigate the Efficacy and Safety of a Standardised Maintenance Dosage Regimen of Intravenous Ferric Carboxymaltose (FERINJECT) Versus Placebo in Patients With Iron Deficiency Caused by Inflammatory Bowel Disease PHASE3 Not recruiting Vifor Inc. Iron Deficiency;Inflammatory Bowel Disease Drug: Ferinject Details
EUCTR2008-002333-75-DE A multi-centre, randomised, prospective, open-label study to investigate the efficacy and safety of a standardised correction dosage regimen of intravenous ferric carboxymaltose (FERINJECT) versus iron sucrose (VENOFER) for treatment of iron deficiency anaemia in patients with inflammatory bowel disease Not Available Not Recruiting Vifor (International) Inc. Iron deficiency anaemia in patients with inflamma… Trade Name: FERINJECT 50 mg iron/ml solution for … Details
EUCTR2008-003591-22-DE A multi-centre, randomised, prospective, single-blinded, controlled study to investigate the efficacy and safety of a standardised maintenance dosage regimen of intravenous ferric carboxymaltose (FERINJECT) versus placebo in patients with iron deficiency caused by inflammatory bowel disease Not Available Not Recruiting Vifor (International) Inc. Iron deficiency anaemia in patients with inflamma… Trade Name: FERINJECT 50 mg iron/ml solution for … Details
NCT04587141 Clinical Burden of Anemia in Inflammatory Bowel Disease: Therapeutic Trial PHASE3 UNKNOWN Fondazione IRCCS Policlinico San Matteo di Pavia Iron Deficiency Anemia|Inflammatory Bowel Diseases DRUG: Sucrosomial iron|DRUG: Ferric Gluconate|DRU… Details
NCT02086968 Multicenter Randomized Open-label Controlled Study to Investigate Treatment Response of IV Injectafer vs Oral Iron to Baseline Hepcidin Levels in Patients With Iron Deficiency Anemia Secondary to Inflammatory Bowel Disease or Gastric Bypass PHASE4 Not recruiting American Regent, Inc. Iron Deficiency Anemia Secondary to IBD or Gastri… Drug: Injectafer;Drug: Ferrous Sulfate tablets Details

Disease IDDisease NameDefinitionCategoryRelated DrugsMechanism
No data available

Strategy IDTherapeutic StrategySynonymsRelated DrugsMechanism
No data available

Intravenous Ferric Carboxymaltose in Children with Iron Deficiency Anemia Who R…

PMID: 27776750
Year: 2017
Relationship Type: Treatment Score: 6.3

OBJECTIVE: To assess the benefits and risks of intravenous (IV) ferric carboxymaltose (FCM) in children with iron deficiency anemia (IDA). STUDY DESI…

TREATMENT OF ANEMIA AND IMPROVEMENT OF QUALITY OF LIFE AMONG PATIENTS WITH CROH…

PMID: 26840464
Year: 2015
Relationship Type: Treatment Score: 6.3

OBJECTIVES: Anemia is the most common hematological alteration in patients with Crohn's disease, and is frequently related to intestinal inflammatory…

The role of ferric carboxymaltose in the treatment of iron deficiency anemia in…

PMID: 26770269
Year: 2016
Relationship Type: Treatment Score: 6.3

Iron deficiency anemia (IDA) is the most common form of nutritional anemia worldwide. Iron plays a pivotal role in vital functioning of almost every …

Effectiveness and safety of ferric carboxymaltose treatment in children and ado…

PMID: 25326048
Year: 2014
Relationship Type: Treatment Score: 6.3

BACKGROUND: The treatment of iron deficiency anemia in children with inflammatory bowel disease is a particular challenge and often insufficient. Abs…

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