IRON ISOMALTOSIDE 1000
drugOn this page
Also known as DiaferIsoferJilazoMonoferMonofer (isomaltoside)
Summary
Iron Isomaltoside 1000 (CHEMBL4298046) is a phase-3 clinical-stage unknown; indicated across 7 conditions including inflammatory bowel disease and chronic kidney disease.
At a glance
- Status: Max clinical phase 3 (not approved)
- Modality: Unknown
- Indications: 7 conditions
- Clinical trials: 30
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL4298046 |
| Name | IRON ISOMALTOSIDE 1000 |
| Type | Unknown |
| Max phase | 3 |
Also known as: Diafer, Iron isomaltoside 1000, Isofer, Jilazo, Monofer, Monofer (isomaltoside), IRON ISOMALTOSIDE 1000
Targets
Targets
No target linkage available.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
7 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| inflammatory bowel disease | 3 | MONDO:0005265 | EFO:0003767 |
| chronic kidney disease | 3 | MONDO:0005300 | EFO:0003884 |
| iron deficiency anemia | 3 | MONDO:0001356 | HP:0001891 |
| restless legs syndrome | 2 | MONDO:0005391 | EFO:0004270 |
| anemia | 1 | MONDO:0002280 | EFO:0004272 |
| neoplasm | 1 | MONDO:0005070 | MONDO:0004992 |
1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 30.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE3 | 11 |
| Not specified | 7 |
| PHASE4 | 5 |
| PHASE1 | 3 |
| PHASE2 | 2 |
| PHASE2/PHASE3 | 1 |
| EARLY_PHASE1 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT05719376 | PHASE4 | NOT_YET_RECRUITING | The Effect of Intravenous Iron Therapy and Erythropoiesis-stimulation Agent Combination on Renal Transplant Outcomes |
| NCT01927328 | PHASE4 | UNKNOWN | Iron Replacement in Oesophagogastric Neoplasia |
| NCT02905539 | PHASE4 | COMPLETED | A Study Comparing the Iron Substitution With the Medicinal Products Ferinject or Monofer |
| NCT03188445 | PHASE4 | COMPLETED | Intravenous Iron Isomaltoside Versus Oral Iron Supplementation for Treatment of Iron Deficiency in Pregnancy. |
| NCT04505514 | PHASE4 | UNKNOWN | Single Dose Intravenous Iron Isomaltoside in Combination With Oral Iron vs Oral Iron Monotherapy in Patients With Anemia After Postpartum Haemorrhage |
| NCT05251493 | PHASE3 | RECRUITING | Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy |
| NCT01017614 | PHASE3 | COMPLETED | Iron Oligosaccharide in Inflammatory Bowel Disease Subjects With Iron Deficiency Anaemia |
| NCT01102413 | PHASE3 | COMPLETED | Iron Isomaltoside 1000 (Monofer®) in Non-Dialysis Dependent Chronic Kidney Disease and With Renal-Related Anaemia |
| NCT01145638 | PHASE3 | COMPLETED | A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA) |
| NCT01222884 | PHASE3 | COMPLETED | A Randomized, Comparative, Open-label Study of IV Monofer® Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison With IV Iron Sucrose in Subjects With CKD-5D |
| NCT01410435 | PHASE3 | COMPLETED | Safety and Efficacy Extension Study of Iron Isomaltoside 1000 (Monofer®) in Subjects With Inflammatory Bowel Disease |
| NCT01599702 | PHASE3 | COMPLETED | Iron Isomaltoside 1000 (Monofer®) Administered by a High Dosing Regimen in Subjects With Inflammatory Bowel Disease |
| NCT01895205 | PHASE3 | COMPLETED | Treatment of Women After Severe Postpartum Haemorrhage |
| NCT01895218 | PHASE3 | COMPLETED | Treatment of Women After Postpartum Haemorrhage |
| NCT02172001 | PHASE3 | WITHDRAWN | A Randomized, Double-blind, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Against Placebo |
| NCT02972294 | PHASE3 | TERMINATED | HiFIT Study : Hip Fracture: Iron and Tranexamic Acid |
| NCT03662789 | PHASE2/PHASE3 | COMPLETED | Intravenous Iron Supplement for Iron Deficiency in Cardiac Transplant Recipients |
| NCT05913414 | PHASE2 | RECRUITING | Iron Isomaltide for Iron-deficiency Anemia Patients With Locally Advanced Nasopharyngeal Carcinoma |
| NCT02484768 | PHASE2 | WITHDRAWN | IV Iron Treatment of Restless Legs Syndrome |
| NCT01213680 | PHASE1 | COMPLETED | Open-label PK Study of Iron Isomaltoside 1000 (Monofer) Administered by 500 mg IV Injection or 1000 mg IV Infusion to Patients With Inflammatory Bowel Disease |
| NCT01213979 | PHASE1 | COMPLETED | Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 500 mg IV Bolus Injection or 1000 mg Intravenous Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia (CIA) |
| NCT01213992 | PHASE1 | COMPLETED | Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 500 mg IV Bolus Injection or 1000 mg Intravenous to Patients With CKD |
| NCT04061655 | EARLY_PHASE1 | COMPLETED | Effect of Intravenous Iron Supplementation in Reducing Allogenic Blood Transfusion |
| NCT01628770 | Not specified | COMPLETED | Use of Iron Isomaltoside 1000 (Monofer) in Postpartum Anemia |
| NCT03094182 | Not specified | UNKNOWN | Efficacy of Intravenous Iron Therapy in Maintaining Hemoglobin Concentration on Patients Undergoing Bimaxillary Orthognathic Surgery |
| NCT03346213 | Not specified | COMPLETED | CArdio PulmOnary Exercise Testing and IntRAvenous Iron- ‘CAPOEIRA-I STUDY’ |
| NCT03470649 | Not specified | COMPLETED | Effect of IV Iron Isomaltoside on Postoperative Anemia in Total Knee Arthroplasty Patients |
| NCT03888768 | Not specified | UNKNOWN | ProPBM : A Modified Patient Blood Management Protocol |
| NCT04318405 | Not specified | COMPLETED | Real Life Study on Iron Isomaltoside 1000 in the Treatment of ID in CKD, Heart Failure, ObGyn, IBD, Cancer and Elective Surgery (Real-CHOICE). |
| NCT05581420 | Not specified | UNKNOWN | Oral Versus Intravenous Iron in IBD Patients With Anti-inflammatory Therapy. |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).