iron dextran
Trade name: INFeD
Approved
Apr 25, 1957
Sucroferric oxyhydroxide, sold under the brand name Velphoro, is a non-calcium, iron-based phosphate binder used for the control of serum phosphorus levels in adults with chronic kidney disease (CKD) on hemodialysis (HD) or peritoneal dialysis (PD). It is used in form of chewable tablets. — Wikipedia
Clinical trial activity
118 trials · 116 clinical orgs · 12 marketing orgs
Earliest trial started Feb 1, 2001 (NCT00236964)
Timeline
1950s
- Apr 25, 1957
Earliest FDA Approval
- Apr 25, 1957
Sanofi-Aventis — NDA Secondary Org
- Apr 25, 1957
Sanofi-Aventis — Marketing Organization
1980s
- Mar 26, 1981
New River Pharmaceuticals — NDA Secondary Org
- Mar 26, 1981
New River Pharmaceuticals — Marketing Organization
1990s
2000s
2010s
- Mar 31, 2011
West-Ward Pharmaceutical — Marketing Organization
- Mar 31, 2011
Hikma — Marketing Organization
- Nov 27, 2013
Fresenius — Marketing Organization
- Nov 27, 2013
Fresenius — NDA Secondary Org
2020s
- Aug 8, 2025
International Medication — Marketing Organization
- Aug 8, 2025
Mylan — Marketing Organization
- Aug 8, 2025
Sandoz — Marketing Organization
Indications
Approved for
Studied for
- Acute Kidney Injury · Phase 2
- Anemia · Phase 4
- Anemia, Iron-Deficiency · Phase 4
- Aortic Valve Stenosis · Phase 4
- Arthropathy, Neurogenic · Phase 2
- Asthma · Phase 4
- Bariatric Surgery · Phase 4
- Blood Loss, Surgical · Phase 4
- Chronic Kidney Disease-Mineral and Bone Disorder · Phase 4
- Colitis, Ulcerative · Phase 3
- Colorectal Neoplasms · Phase 4
- Critical Illness · Phase 2
- Crohn Disease · Phase 3
- Delivery, Obstetric · Phase 4
- Dialysis · Phase 4
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Endometrial Neoplasms · Phase 4
- Fatigue · Phase 3
- Fractures, Bone · Phase 4
- Gastric Bypass · Phase 4
- General Surgery · Phase 4
- Hamartoma · Phase 4
- Healthy Volunteers · Phase 4
- Heart Diseases · Phase 1/Phase 2
- Heart Failure · Phase 4
- Hematologic Neoplasms · Phase 2/Phase 3
- Hip Fractures · Phase 4
- Hyperphosphatemia · Phase 4
- Hypertension, Pulmonary · Phase 2
- Hypoalbuminemia · Phase 4
- Infant, Premature, Diseases · Phase 2
- Inflammatory Bowel Diseases · Phase 4
- Iron Deficiencies · Phase 4
- Iron Overload · Phase 4
- Kidney Diseases · Phase 4
- Kidney Failure, Chronic · Phase 4
- Leukemia · Phase 3
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 3
- Lymphoma · Phase 3
- Lymphoma, Non-Hodgkin · Phase 3
- Lymphoproliferative Disorders · Phase 3
- Malnutrition · Phase 4
- Multiple Myeloma · Phase 3
- Neoplasms · Phase 3
- Osteoarthritis · Phase 4
- Precancerous Conditions · Phase 3
- Pregnancy · Phase 2
- Pregnancy Complications · Phase 4
- Preoperative Exercise · Phase 4
- Puerperal Disorders · Phase 4
- Renal Dialysis · Phase 4
- Renal Insufficiency · Phase 3
- Renal Insufficiency, Chronic · Phase 4
- Restless Legs Syndrome · Phase 2
- Weight Loss · Phase 3
- Wounds and Injuries · Phase 2
Mechanism of action
- PhosphateBINDING AGENT
Phosphate binding agent
- Unspecified targetOTHER
Supplement
- PhosphateSEQUESTERING AGENT
Phosphate sequestering agent
It is a phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis
- IronSupplementation
Iron supplementation
Approval history
- approvedPriority reviewApr 25, 1957
Chemistry & pharmacology
- Mol. weight
- 398.14 g/mol
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaSucroferric oxyhydroxide ↗
- ChEMBLCHEMBL3833303 ↗
- ChEMBLCHEMBL3039566 ↗
- ChEMBLCHEMBL1201544 ↗
- ChEMBLCHEMBL1201494 ↗
- ChEMBLCHEMBL1200823 ↗
- ChEMBLCHEMBL4802224 ↗
- WikipediaSodium ferric gluconate complex ↗
Also known as
- apo-ferrous gluconate
- dextran iron
- dextriferron
- eisen-sandoz
- feg iron
- fergon
- fergon
- fergon
- ferric gluconate
- ferric gluconate anhydrous
- ferric gluconate, sodium salt
- ferric gluconate trihydrate
- ferric hydroxide sucrose complex
- ferric hydroxide sucrose complex
- ferric hydroxide sucrose complex
- ferric oxide saccharated
- ferric oxide, saccharated
- ferric oxide, saccharated
- ferric saccharate
- ferric sodium gluconate complex
- ferric sodium gluconate complex
- ferri-saccharate
- ferrlecit
- ferrlecit
- ferrlecit
- ferrlecit
- ferrlecit 100
- ferroglucon
- ferrogluconaat fna
- ferroglyconicum
- ferrous gluconate
- ferrous gluconate
- ferrous gluconate
- ferrous gluconate
- ferrous gluconate
- ferrous gluconate
- ferrum verla
- glucoferron
- hippiron
- iron dextran
- iron dextran
- iron dextran
- iron dextran
- iron dextran
- iron dextran
- iron dextran complex
- iron dextran complex
- iron gluconate
- iron(iii) hydroxide sucrose complex
- iron(iii) hydroxide sucrose complex
- iron(iii) hydroxide sucrose complex
- iron(iii)-hydroxide sucrose complex
- iron oxide saccharated
- iron oxide saccharated
- iron oxide saccharated
- iron oxide (saccharated)
- iron saccharate
- iron saccharate
- iron saccharate
- iron saccharate
- iron saccharate
- iron-saccharate
- iron sucrose
- iron sucrose
- iron sucrose
- iron sucrose
- iron sucrose
- iron sucrose
- iron sucrose complex
- iron sucrose complex
- iron sucrose complex
- iron sugar
- iron sugar
- iron sugar
- loesferron
- losferron
- low molecular weight iron dextran
- polysaccharide iron complex
- rulofer g
- saccharated ferric oxide
- saccharated ferric oxide
- saccharated ferric oxide
- saccharated ferric oxide
- saccharated iron
- saccharated iron
- saccharated iron
- saccharated iron oxide
- saccharated iron oxide
- saccharated iron oxide
- saccharated iron oxide
- saccharated iron oxide
- sideromal
- simron
- sodium ferric gluconate
- sodium ferric gluconate complex
- sodium ferric gluconate complex
- sodium ferric gluconate complex
- sodium ferric gluconate complex
- sodium ferric gluconate complex
- sodium ferric gluconate complex
- sodium ferric gluconate complex
- sodium ferric gluconate complex
- sodium ferric gluconate complex
- sodium ferric gluconate complex in sucrose
- sodium ferrigluconate
- sodium iron(iii)gluconate
- sucroferric oxyhydroxide
- sucroferric oxyhydroxide
- sucroferric oxyhydroxide
- sucroferric oxyhydroxide
- sucroferric oxyhydroxide
- sucroferric oxyhydroxide
- sucroferric oxyhydroxide
- sucroferric oxyhydroxide
- sucroferric oxyhydroxide
- velphoro
- velphoro
- venofer
- venofer
- venofer
- vitaferro brause
- xi-921
- xi-921
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06366698 | Phase 3 | Nov 21, 2023 | University of California, Irvine |
| NCT06061393 | Phase 4 | Oct 30, 2023 | Western Galilee Hospital |
| NCT06012760 | N/A | Aug 30, 2023 | Zhejiang University |
| NCT05714176 | Phase 4 | Feb 1, 2023 | Menoufia University, Tanta University |
| NCT05960227 | Phase 2 | Jan 6, 2023 | University of Guadalajara |
| NCT06049693 | Phase 4 | Jan 1, 2023 | University of Athens |
| NCT05340465 | Phase 2 | Oct 10, 2022 | National Institutes of Health (NIH), University of Washington |
| NCT05292001 | Phase 4 | May 2, 2022 | Collins Medical Trust, Oregon Health and Science University |
| NCT05167734 | Phase 2 | Nov 30, 2021 | Mayo Clinic, National Heart, Lung, and Blood Institute (NHLBI) |
| NCT05047211 | Phase 4 | Oct 7, 2021 | University of Texas, Galveston |
| NCT04797832 | Phase 4 | Oct 18, 2020 | Technion University |
| NCT04587141 | Phase 3 | Jan 1, 2020 | Italian Group for the study of Inflammatory Bowel Disease (IG-IBD), University of Pavia |
| NCT04063033 | Phase 4 | Sep 1, 2019 | Technion University |
| NCT04046263 | Phase 4 | Sep 1, 2019 | University of Colorado, Denver |
| NCT03915327 | N/A | Jun 1, 2019 | Sichuan University |
| NCT03528564 | Phase 2 | Oct 1, 2018 | University of Toronto |
| NCT03438227 | Phase 4 | Apr 15, 2018 | Washington University in St. Louis |
| NCT03279536 | Phase 1/Phase 2 (Phase 2) | Jul 1, 2017 | Assiut University |
| NCT02009943 | Phase 1 | Feb 1, 2017 | University of Colorado |
| NCT03009578 | Phase 3 | Feb 1, 2017 | Assiut University |
Organizations
Research & Development (116)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Daiichi Sankyo | For profit | 14 | 13 | 3 | 2001 |
| Watson Pharmaceuticals | For profit | 10 | 10 | 3 | 2002 |
| National Heart, Lung, and Blood Institute (NHLBI) | Government | 5 | 2 | 3 | 2004 |
| Pharmacosmos | For profit | 5 | 4 | 2 | 2011 |
| AMAG Pharmaceuticals, Inc. | For profit | 3 | 3 | 3 | 2010 |
| Assiut University | Academic/Hospital | 3 | 3 | 2 | 2016 |
| University of Colorado | Academic/Hospital | 3 | 3 | 3 | 2011 |
| University of Oxford | Academic/Hospital | 3 | 3 | 3 | 2008 |
| American National Red Cross | Academic/Hospital | 2 | 0 | 2 | 2011 |
| Amgen | For profit | 2 | 1 | 2 | 2004 |
| Ben Gurion University | Academic/Hospital | 2 | 2 | 2 | 2005 |
| Blood Center of Wisconsin | Academic/Hospital | 2 | 0 | 2 | 2011 |
| ClinStar, LLC | For profit | 2 | 0 | 1 | 2008 |
| Duke University | Academic/Hospital | 2 | 2 | 2 | 2011 |
| Emek Medical Center | Academic/Hospital | 2 | 2 | 1 | 2016 |
| Mayo Clinic | Academic/Hospital | 2 | 2 | 2 | 2006 |
| Papageorgiou General Hospital | Academic/Hospital | 2 | 2 | 1 | 2005 |
| Rijnstate Hospital | Academic/Hospital | 2 | 2 | 1 | 2014 |
| Technion University | Academic/Hospital | 2 | 2 | 1 | 2019 |
| University of Barcelona | Academic/Hospital | 2 | 2 | 1 | 2005 |
Marketing (17)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Allergan | For profit | NDA2 | Apr 29, 1974 |
| Allergan | For profit | MKTG | Apr 29, 1974 |
| Fresenius | For profit | MKTG | Nov 27, 2013 |
| Fresenius | For profit | NDA2 | Nov 27, 2013 |
| Hikma | For profit | MKTG | Mar 31, 2011 |
| International Medication | For profit | MKTG | Aug 8, 2025 |
| Lutipold | For profit | NDA2 | Feb 23, 1996 |
| Mylan | For profit | MKTG | Aug 8, 2025 |
| New River Pharmaceuticals | For profit | NDA2 | Mar 26, 1981 |
| New River Pharmaceuticals | For profit | MKTG | Mar 26, 1981 |
| Sandoz | For profit | MKTG | Aug 8, 2025 |
| Sankyo | For profit | MKTG | Feb 23, 1996 |
| Sankyo | For profit | NDA2 | Feb 23, 1996 |
| Sanofi | For profit | NDA | — |
| Sanofi-Aventis | For profit | NDA2 | Apr 25, 1957 |
| Sanofi-Aventis | For profit | MKTG | Apr 25, 1957 |
| West-Ward Pharmaceutical | For profit | MKTG | Mar 31, 2011 |