Drugs / Ferric derisomaltose
Ferric derisomaltose
also known as
iron isomaltoside · Monoferric · iron isomaltoside 1000 · FDI · IIM · Iron isomaltoside/ferric derisomaltose · Monofer · Ferric Derisomaltose Injection · +1 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | MONOFERRIC | — | 2020-01-16 | fda.gov ↗ |
Trials 27
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05763043 | Jan 2024 → Oct 2028 expected | dystocia | Oregon Health and Science University | Recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07643818 | Jun 2026 → Jul 2029 expected | diastolic heart failure | Government of Jersey | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT06287619 | Apr 2025 → Dec 2026 expected | iron deficiency anemia | University Health Network, Toronto | Recruiting | No outcome recorded |
| Phase 311 trials · 3 met primary | ||||||
| Phase 3 | NCT06929806 | May 2025 → Dec 2027 expected | disorder of iron metabolism and transport, symptomatic heart failure | Pharmacosmos A/S | Recruiting | No outcome recorded |
| Phase 3 | NCT05407987 | Apr 2025 → Dec 2026 expected | female reproductive organ cancer, iron deficiency anemia | AHS Cancer Control Alberta | Recruiting | No outcome recorded |
| Phase 3 | NCT05768997 | Mar 2023 → Dec 2025 | anemia | Hallym University Medical Center | Unknown | No outcome recorded |
| Phase 3 | NCT05462704 | Jan 2023 → Mar 2027 expected | iron deficiency anemia, pregnancy disorder | Women and Infants Hospital of Rhode Island | Recruiting | No outcome recorded |
| Phase 3 | NCT05179226 | Nov 2022 → Apr 2026 overdue | iron deficiency anemia | Pharmacosmos A/S | Recruiting | No outcome recorded |
| Phase 3 | NCT05467319 | Sep 2022 → Sep 2023 | female reproductive organ cancer, iron deficiency anemia | Alberta Health Services, Calgary | Unknown | No outcome recorded |
| Phase 3 | NCT05304442 | Sep 2022 → Mar 2025 overdue | iron deficiency anemia, uterine disorder | Baylor College of Medicine | Recruiting | No outcome recorded |
| Phase 3 | NCT03237065 | Oct 2017 → May 2018 | iron deficiency anemia | Pharmacosmos A/S | Completed | Met primary |
| Phase 3 | NCT02962648 | Jan 2017 → Jun 2018 | iron deficiency anemia | Pharmacosmos A/S | Completed | No outcome recorded |
| Phase 3 | NCT02940860 | Nov 2016 → May 2018 | chronic kidney disease, iron deficiency anemia | Pharmacosmos A/S | Completed | Met primary |
| Phase 3 | NCT02940886 | Nov 2016 → Mar 2018 | iron deficiency anemia | Pharmacosmos A/S | Completed | Met primary |
| Phase 412 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT07686692 | Aug 2026 → Aug 2030 expected | diastolic heart failure, disorder of iron metabolism and transport | Duke University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07238972 | Dec 2025 → Aug 2030 expected | heart valve disorder, iron deficiency anemia, iron metabolism disease | Yonsei University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05929729 | Dec 2023 → Sep 2028 expected | iron deficiency anemia | Children's Hospital Los Angeles | Recruiting | No outcome recorded |
| Phase 4 | NCT06427343 | Oct 2023 → Sep 2026 overdue | disorder of iron metabolism and transport, heart failure | China-Japan Friendship Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT05714007 | Aug 2023 → Dec 2025 overdue | anemia | Peking Union Medical College Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT05991128 | Aug 2023 → Aug 2024 | diastolic heart failure, disorder of iron metabolism and transport | China-Japan Friendship Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05971732 | Aug 2023 → Aug 2024 | disorder of iron metabolism and transport, symptomatic heart failure | China-Japan Friendship Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05258825 | Nov 2022 → Mar 2023 | anemia | Brigham and Women's Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04913649 | Sep 2021 → Nov 2026 expected | iron deficiency anemia | dr. P. Noordzij | Recruiting | No outcome recorded |
| Phase 4 | NCT04608539 | May 2021 → Jun 2023 | aregenerative anemia | Michael Kremke | Completed | No outcome recorded |
| Phase 4 | NCT03188445 | Jul 2017 → Jun 2020 | iron deficiency anemia | Pharmacosmos A/S | Completed | Met primary |
| Phase 4 | NCT02642562 | Aug 2016 → Aug 2022 | disorder of iron metabolism and transport, systolic heart failure | University of Glasgow | Completed | Missed primary |
| Phase not applicable1 trial | ||||||
| — | NCT05911438 | Jul 2023 → Dec 2024 | — | West China Hospital | Unknown | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 2/3 | NCT04945707 Comparator | Nov 2021 → Jun 2026 | heart failure, iron metabolism disease | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 3 | NCT05251493 Comparator | Jun 2022 → Dec 2026 expected | iron deficiency anemia | Saskatchewan Health Authority - Regina Area | Recruiting | No outcome recorded |
| Phase 4 | NCT07659184 Comparator | Oct 2026 → Sep 2028 expected | anemia | University of Aarhus | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06898814 Comparator | Jun 2025 → Jun 2027 expected | anemia | Soren Overgaard | Recruiting | No outcome recorded |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 37 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ferric derisomaltose | “METHODS: In this randomised comparative, open-label, single-centre, phase IV trial, 200 pregnant women between 14 and 21 weeks of gestation who have iron deficiency after...” PMID 32843079 ↗ Aug 202027“Ferric derisomaltose will be prepared by an unblinded research pharmacist/delegated staff as per standard of care procedures.” NCT06287619 ↗ |
| Known as | FDI | “The primary objective is to compare the effect of a single dose of ferric derisomaltose (FDI) (20 mg/kg body weight) relative to placebo on patients' recovery of functional...” NCT06898814 ↗1“Intravenous iron therapy with ferric derisomaltose (FDI) has been shown to improve outcomes in patients with heart failure with reduced ejection fraction (HFrEF) and iron deficiency.” PMID 39938943 ↗ Jun 2025 |
| Known as | Ferric Derisomaltose Injection | “Ferric Derisomaltose Injection (Monoferric): 1000 mg, intravenous infusion 6±2 days before surgery” NCT05911438 ↗ |
| Known as | IIM | “The FERWON-NEPHRO trial evaluated the safety and efficacy of iron isomaltoside 1000/ferric derisomaltose (IIM) in patients with non-dialysis-dependent chronic kidney disease...” PMID 32049331 ↗ Jan 20211“The present trial (FERWON-IDA) is part of the FERWON program with iron isomaltoside 1000/ferric derisomaltose (IIM), evaluating safety and efficacy of high dose IIM in IDA...” PMID 31243803 ↗ Jul 2019 |
| Known as | iron (III) isomaltoside 1000 | “Iron to be administered as iron (III) isomaltoside 1000 / ferric derisomaltose.” NCT02642562 ↗ |
| Known as | iron isomaltoside | “The FERWON-NEPHRO trial evaluated the safety and efficacy of iron isomaltoside 1000/ferric derisomaltose (IIM) in patients with non-dialysis-dependent chronic kidney disease...” PMID 32049331 ↗ Jan 20213“a single 1000 mg dose of intravenously administered ferric derisomaltose/iron isomaltoside 1000 or a fixed dose of 100 mg oral ferrous fumarate containing 60 mg ascorbic acid.” PMID 32843079 ↗ Aug 2020 “iron isomaltoside (now known as ferric derisomaltose)” PMID 32016310 ↗ Feb 2020 “Ferric derisomaltose/iron isomaltoside (as iron)” NCT05768997 ↗ |
| Known as | iron isomaltoside 1000 | “The FERWON-NEPHRO trial evaluated the safety and efficacy of iron isomaltoside 1000/ferric derisomaltose (IIM) in patients with non-dialysis-dependent chronic kidney disease...” PMID 32049331 ↗ Jan 20212“The present trial (FERWON-IDA) is part of the FERWON program with iron isomaltoside 1000/ferric derisomaltose (IIM), evaluating safety and efficacy of high dose IIM in IDA...” PMID 31243803 ↗ Jul 2019 “The subjects will receive ferric derisomaltose/iron isomaltoside 1000 (Monoferric®) at single doses of 10 mg/kg or 20 mg/kg with a maximal dose of 1000 mg.” NCT05179226 ↗ |
| Known as | Iron isomaltoside/ferric derisomaltose | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02940886 ↗ |
| Known as | Monofer | “Ferric derisomaltose (Monofer) administered as a single intravenous infusion at a dose up to a maximum of 20 mg/kg diluted in 0.9% sodium chloride.” NCT07643818 ↗1“Iron isomaltoside (Monofer) Administered iv” NCT03188445 ↗ |
| Known as | Monoferric | “1000 mg ferric derisomaltose (Monoferric) diluted in 100 mL of 0.9 % sodium chloride solution, via intravenous infusion over 1 hour using an opaque IV bag and tubing for blinding.” NCT06287619 ↗3“Ferric Derisomaltose Injection (Monoferric): 1000 mg, intravenous infusion 6±2 days before surgery” NCT05911438 ↗ “Ferric Derisomaltose 1000 Mg in 10 mL INTRAVENOUS SOLUTION [Monoferric]” NCT05304442 ↗ |
| Action | Restore | “correction of functional iron deficiency by administering a single dose of intravenous iron” NCT04945707 ↗ |
| Route | Intravenous | “Participants were randomly assigned (1:1) using a web-based system to intravenous ferric derisomaltose or usual care.” PMID 36347265 ↗ Nov 2022 |