| 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
Knowledge Graph
| dtID | CID | Compound Name | Gene ID | Gene Name | Species | PubMed IDs | Action |
|---|---|---|---|---|---|---|---|
| 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 ID | Title | Phase | Status | Sponsor | Indications | Interventions | |
|---|---|---|---|---|---|---|---|
| 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 ID | Disease Name | Definition | Category | Related Drugs | Mechanism | |
|---|---|---|---|---|---|---|
| No data available | ||||||
| Strategy ID | Therapeutic Strategy | Synonyms | Related Drugs | Mechanism | |
|---|---|---|---|---|---|
| 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…