ferric derisomaltose
Trade name: Monoferric
Small moleculeapproved
Approved
Jan 16, 2020
Ferric derisomaltose, sold under the brand name Monoferric among others, is a medication for the treatment of iron deficiency anemia in adults who have intolerance to oral iron or have had unsatisfactory response to oral iron or who have non-hemodialysis dependent chronic kidney disease (NDD-CKD). It was approved for use in the United States in January 2020. It is given intravenously. — Wikipedia
Clinical trial activity
78 trials · 73 clinical orgs · 1 marketing orgs
Phase 1
8
Phase 2
35
Phase 3
30
Phase 4
24
Earliest trial started Oct 1, 2009 (NCT01017614)
Timeline
2000s
- Jan 1, 2009
Pharmacosmos — Earliest Phase 3 Sponsor(trial)
2010s
- Jan 1, 2011
Pharmacosmos — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2015
Pharmacosmos — Earliest Phase 2 Sponsor(trial)
2020s
- Jan 16, 2020
Pharmacosmos — Earliest FDA Approval
- Jan 16, 2020
Evidence of US Marketing
- Jan 16, 2020
Pharmacosmos — Marketing Organization
- Jan 16, 2020
Pharmacosmos — NDA Secondary Org
- Jan 16, 2020
Pharmacosmos — NDA Organization
Indications
Studied for
- Adult · Phase 4
- Anemia · Phase 4
- Anemia, Iron-Deficiency · Phase 4
- Aortic Stenosis, Subvalvular · Phase 4
- Bronchiectasis · Phase 3
- Chronic Kidney Disease-Mineral and Bone Disorder · Phase 1
- Colonic Neoplasms · Phase 2
- Colorectal Neoplasms · Phase 4
- Colorectal Surgery · Phase 4
- Deficiency Diseases · Phase 1
- Dialysis · Phase 4
- Drug Misuse · Phase 4
- Drug-Related Side Effects and Adverse Reactions · Phase 3
- Esophageal Neoplasms · Phase 4
- Gastric Bypass · Phase 4
- General Surgery · Phase 4
- Genital Neoplasms, Female · Phase 3
- Heart Failure · Phase 4
- Heart Failure, Diastolic · Phase 4
- Heart Failure, Systolic · Phase 4
- Heart Transplantation · Phase 2/Phase 3
- Heart Valve Diseases · Phase 4
- Hematologic Diseases · Phase 1
- Hip Fractures · Phase 4
- Hypertrophy, Left Ventricular · Phase 4
- Hypophosphatemia · Phase 4
- Infant, Low Birth Weight · Phase 4
- Inflammatory Bowel Diseases · Phase 4
- Iron Deficiencies · Phase 4
- Iron Metabolism Disorders · Phase 1
- Kidney Diseases · Phase 4
- Kidney Failure, Chronic · Phase 4
- Nasopharyngeal Carcinoma · Phase 2
- Neoplasms · Phase 3
- Obstetric Labor Complications · Early Phase 1
- Peritoneal Dialysis · Phase 3
- Postoperative Complications · Phase 4
- Postpartum Hemorrhage · Phase 4
- Pregnancy · Phase 3
- Pregnancy Complications · Phase 4
- Renal Insufficiency, Chronic · Phase 3
- Restless Legs Syndrome · Phase 2
- Spinal Diseases · Phase 4
- Stomach Neoplasms · Phase 4
- Thoracic Surgery · Phase 4
- Uterine Hemorrhage · Phase 3
Mechanism of action
- Transferrin receptorAGONIST
Transferrin receptor agonist
- SerotransferrinBINDING AGENT
TF binding agent
Iron replacement product.
- Unspecified targetOTHER
Supplement
Iron replacement product.
Approval history
- approvedJan 16, 2020
- approvedJan 16, 2020
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Availability
- Prescription Only
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaFerric derisomaltose ↗
- NCATSAHU547PI9H ↗
- ChEMBLCHEMBL4298187 ↗
- ChEMBLCHEMBL4298046 ↗
Also known as
- iron isomaltoside
- isomaltoside
- isomaltoside
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07238972 | Phase 4 | Dec 31, 2025 | Yonsei University |
| NCT06884280 | Phase 3 | Oct 31, 2025 | Hull University Teaching Hospitals NHS Trust, Pharmacosmos |
| NCT06898814 | Phase 4 | Jun 9, 2025 | Svendborg Hospital, University of Copenhagen, University of Southern Denmark |
| NCT06929806 | Phase 3 | May 1, 2025 | Pharmacosmos |
| NCT07236788 | N/A | Mar 1, 2025 | Peking University |
| NCT06830941 | Phase 4 | Feb 15, 2025 | Jiao Tong University |
| NCT06287619 | Phase 2 | Sep 30, 2024 | Heart and Stroke Foundation of Canada, Queen's University, Belfast, University of Toronto |
| NCT06350955 | Phase 4 | May 2, 2024 | University of Lausanne |
| NCT05929729 | Phase 4 | Dec 1, 2023 | Children's Hospital Los Angeles |
| NCT05763043 | Early Phase 1 (Phase 1) | Nov 30, 2023 | Oregon Health and Science University |
| NCT06427343 | Phase 4 | Oct 1, 2023 | Peking University |
| NCT05714007 | Phase 4 | Aug 31, 2023 | Chinese Academy of Medical Sciences, Pharmacosmos |
| NCT05971732 | Phase 4 | Aug 1, 2023 | Peking University |
| NCT05991128 | Phase 4 | Aug 1, 2023 | Peking University |
| NCT05911438 | N/A | Jul 31, 2023 | Sichuan University |
| NCT05913414 | Phase 2 | May 5, 2023 | Sun Yat-Sen University |
| NCT05299411 | Phase 2 | Apr 20, 2023 | Korea University, Pharmbio Korea |
| NCT05804071 | Phase 4 | Mar 28, 2023 | Shandong Province Qianfoshan Hospital |
| NCT05768997 | Phase 3 | Mar 1, 2023 | Hallym University |
| NCT05719376 | Phase 4 | Feb 28, 2023 | Yonsei University |
Showing 20 of 78 trials
Page 1 / 4
Organizations
Research & Development (73)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Pharmacosmos | For profit | 38 | 27 | 4 | 2009 |
| Yonsei University | Academic/Hospital | 6 | 6 | 2 | 2016 |
| BioStata | For profit | 4 | 0 | 2 | 2013 |
| Peking University | Academic/Hospital | 4 | 4 | 2 | 2023 |
| University of Copenhagen | Academic/Hospital | 3 | 3 | 3 | 2022 |
| Harvard University | Academic/Hospital | 2 | 2 | 1 | 2021 |
| LabCorp | For profit | 2 | 0 | 2 | 2014 |
| Max Neeman International | For profit | 2 | 0 | 1 | 2009 |
| Oregon Health and Science University | Academic/Hospital | 2 | 1 | 2 | 2022 |
| University of Calgary | Academic/Hospital | 2 | 2 | 1 | 2022 |
| University of Malaya | Academic/Hospital | 2 | 1 | 2 | 2019 |
| University of Oslo | Academic/Hospital | 2 | 2 | 2 | 2018 |
| University of Southern Denmark | Academic/Hospital | 2 | 0 | 2 | 2022 |
| Aarhus University | Academic/Hospital | 1 | 1 | 1 | 2021 |
| Adrz, Goes | Academic/Hospital | 1 | 0 | 1 | 2022 |
| Ain Shams University | Academic/Hospital | 1 | 1 | 1 | 2019 |
| Baylor University | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Brown University | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Children's Hospital Los Angeles | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 1 | 1 | 1 | 2023 |
73 organizations
Page 1 / 4
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Pharmacosmos | For profit | SYN | Jan 16, 2020 |
| Pharmacosmos | For profit | MKTG | Jan 16, 2020 |
| Pharmacosmos | For profit | NDA2 | Jan 16, 2020 |
| Pharmacosmos | For profit | NDA | Jan 16, 2020 |