Iron sucrose
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | VENOFER | — | 2003-06-02 – 2012-09-21 | fda.gov ↗ |
| Approved | US (FDA) | VENOFER | — | 2000-11-06 | fda.gov ↗ |
Trials 63 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 39 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02009943 Comparator | Feb → Aug 2017 | anemia, disorder of iron metabolism and transport | Denver Health and Hospital Authority | Withdrawn | No outcome recorded |
| Phase 1 | NCT00534144 Comparator | Sep 2007 → Nov 2008 | chronic renal failure syndrome, iron deficiency anemia | Watson Pharmaceuticals | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT07657091 Comparator | Jan → Jun 2027 expected | iron deficiency anemia | Kharadar General Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06487299 Comparator | Jul 2024 → Jan 2026 overdue | iron deficiency anemia | The Second Hospital of Nanjing Medical University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT02499354 Comparator | Aug 2014 → Sep 2021 | iron deficiency anemia, restless legs syndrome | Auerbach Hematology Oncology Associates P C | Completed | No outcome recorded |
| Phase 2 | NCT01052779 Comparator | Mar 2010 → Jul 2011 | anemia, disorder of iron metabolism and transport, kidney disorder | AMAG Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01290315 Comparator | Aug 2009 → Mar 2013 | iron deficiency anemia | American Regent, Inc. | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT00318812 Comparator | May 2007 → Dec 2011 | chronic kidney disease, iron deficiency anemia | Ottawa Hospital Research Institute | Completed | No outcome recorded |
| Phase 2/3 | NCT00557817 Comparator | Mar 2004 → Aug 2008 | hematopoietic and lymphoid cell neoplasm | University of Liege | Completed | No outcome recorded |
| Phase 315 trials | ||||||
| Phase 3 | NCT06366698 Comparator | Nov 2023 → Dec 2025 | iron deficiency anemia | Arrowhead Regional Medical Center | Unknown | 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 3 | NCT03893045 Comparator | Sep 2019 → Jul 2026 overdue | iron deficiency anemia | AMAG Pharmaceuticals, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT03619850 Comparator | Aug 2018 → Aug 2026 overdue | chronic kidney disease, iron deficiency anemia | AMAG Pharmaceuticals, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT03591406 Comparator | Jul 2017 → Feb 2019 | iron deficiency anemia | Vifor (International) Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02940860 Comparator | Nov 2016 → May 2018 | chronic kidney disease, iron deficiency anemia | Pharmacosmos A/S | Completed | No outcome recorded |
| Phase 3 | NCT02940886 Comparator | Nov 2016 → Mar 2018 | iron deficiency anemia | Pharmacosmos A/S | Completed | No outcome recorded |
| Phase 3 | NCT02130063 Comparator | May 2014 → Aug 2015 | iron deficiency anemia | Pharmacosmos A/S | Completed | No outcome recorded |
| Phase 3 | NCT02390102 Comparator | Jun 2012 → Jun 2015 | anemia, aortic valve stenosis | Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec | Completed | No outcome recorded |
| Phase 3 | NCT01222884 Comparator | Jun 2011 → Oct 2013 | end stage renal failure | Pharmacosmos A/S | Completed | No outcome recorded |
| Phase 3 | NCT01114204 Comparator | Aug 2010 → Nov 2011 | iron deficiency anemia | AMAG Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00981045 Comparator | Aug 2009 → Jul 2011 | impaired renal function disease, iron deficiency anemia | American Regent, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00810030 Comparator | Oct 2008 → Dec 2009 | Crohn disease, disorder of iron metabolism and transport, iron deficiency anemia, ulcerative colitis | Vifor Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00704353 Comparator | Jun 2008 → Jul 2009 | anemia | American Regent, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00236951 Comparator | Feb 2003 → Oct 2005 | anemia | American Regent, Inc. | Completed | No outcome recorded |
| Phase 412 trials | ||||||
| Phase 4 | NCT06911034 Comparator | Feb → Jul 2024 | iron deficiency anemia, pregnancy disorder | CMH Multan Institute of Medical Sciences | Completed | No outcome recorded |
| Phase 4 | NCT06061393 Comparator | Oct 2023 → Sep 2025 | iron deficiency anemia | Western Galilee Hospital-Nahariya | Unknown | No outcome recorded |
| Phase 4 | NCT05921968 Comparator | Jul 2023 → Jan 2024 | iron deficiency anemia | Ain Shams University | Unknown | No outcome recorded |
| Phase 4 | NCT05691257 Background | Feb → Aug 2023 | anemia, chronic kidney disease, heart failure | China-Japan Friendship Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT06556134 Comparator | Jul 2021 → Jul 2023 | anemia due to chronic disorder | Centre Hospitalier Hassan II - Fès | Completed | No outcome recorded |
| Phase 4 | NCT04225728 Comparator | Dec 2017 → Jun 2018 | disorder of iron metabolism and transport, heart failure | CN NGANOU-GNINDJIO, MD, MSc | Completed | No outcome recorded |
| Phase 4 | NCT02707757 Comparator | Jul 2015 → Dec 2016 | anemia | Imperial College Healthcare NHS Trust | Completed | No outcome recorded |
| Phase 4 | NCT03658876 Comparator | Jun 2015 → Dec 2016 | anemia, chronic renal failure syndrome | Imperial College London | Completed | No outcome recorded |
| Phase 4 | NCT02198495 Comparator | Sep 2014 → May 2019 | anemia due to chronic disorder | Medical University of Vienna | Completed | No outcome recorded |
| Phase 4 | NCT01227616 Comparator | Aug 2013 → Feb 2016 | chronic kidney disease, iron deficiency anemia | AMAG Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00593619 Comparator | Jan 2008 → Dec 2009 | iron deficiency anemia | London Health Sciences Centre | Suspended | No outcome recorded |
| Phase 4 | NCT00660933 Comparator | Sep 2005 → Sep 2007 | anemia, puerperal disorder | Hospital Clinic of Barcelona | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT01888003 Comparator | Apr 2013 → Jan 2015 | iron deficiency anemia | University of Alabama at Birmingham | Terminated | No outcome recorded |
| — | NCT01180894 Comparator | Jun 2011 → Sep 2013 | anemia | Denver Health and Hospital Authority | Completed | No outcome recorded |
| — | NCT01349699 Comparator | Feb → May 2010 | anemia, autoinflammatory syndrome | Radboud University Medical Center | Completed | No outcome recorded |
Press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-08-11 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Viatris Announces Approval of First Generic Iron Sucrose Injection in the U.S. viatris.com ↗ |
| 2019-01-22 | CSL Behring | Vifor Pharma Press Release Updated on Analysis of Venofer in High Dosage Study csl.com ↗ |
| 2018-10-29 | CSL Behring | Pivotal trial confirms long-term safety and efficacy of IV iron dosing strategy csl.com ↗ |
| 2008-07-09 | Daiichi Sankyo | Luitpold Pharmaceuticals/American Regent and Fresenius Medical Care sign agreements for exclusive sublicense of Venofer(R)in U.S. daiichisankyo.com ↗ |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 103 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | iron sucrose | “RBT-1 is a combination drug of stannic protoporfin (SnPP) and iron sucrose (FeS) that elicits a preconditioning response through activation of antioxidant, anti-inflammatory,...” PMID 38586479 ↗ Jan 202488“We developed an intraoperative novel method for distinguishing intersegmental planes of the lung via transbronchial injection of iron sucrose (ClinicalTrials.gov number, NCT03516500).” PMID 37096093 ↗ Jan 2023 “Other drugs to treat anemia include: Recombinant human eythropoietin (RH-EPO), iron agents (ferrous succinate, polysaccharide iron complex, iron sucrose, etc.)” NCT05691257 ↗ “12 healthy volunteers will be administered a single dose of 12 mg Iron Sucrose and 9 mg of Stannous Protoporphyrin and followed for seven days.” NCT03630029 ↗ “IV iron sucrose 200 mg over 2 hours baseline visit, week 2, week 4, week 6 and week 8 for a total of 1000mg total dose.” NCT00830037 ↗ “Iron sucrose will be given by continuous infusion for 1 hour during the last 1 hour of dialysis session.” NCT04464850 ↗ “The study group received 200mg of intravenous iron sucrose immediately after each chemotherapy infusion.” PMID 24099839 ↗ Oct 2013 “Iron Sucrose, Iron Gluconate or Iron Isomaltoside (Treatment group A) versus No Iron Infusion treatment” NCT06248749 ↗ “5 mg/kg of intravenous iron sucrose (maximum dose of 200 mg). Iron sucrose will be diluted” NCT04855266 ↗ “5 mg/kg of intravenous iron sucrose supplied as Venofer (TM) with a maximum dose of 200mg.” NCT01978535 ↗ “500 mg iron sucrose (Venofer®, Vifor International AG, St. Gallen, Switzerland)” NCT00746551 ↗ “five doses of 200 mg of iron sucrose (Venofer, American Regent, Shirley, NJ)” NCT05800600 ↗ “Combinaison drug of darboepoetin 0.75µg/Kg + 200mg intravenous iron sucrose” NCT02390102 ↗ “iron sucrose, 200 μg/kg per day, was given everyday with PN,” NCT02060851 ↗ “100mg/week of Venofer â (iron sucrose) from week 0 to 6” NCT00145652 ↗ “Treatment with iron sucrose with orginal guideline” NCT04491916 ↗ “one 500 mg IV iron sucrose infusion” NCT00895232 ↗ “Iron sucrose” NCT00952302 ↗ |
| Known as | FERIV | “Iron sucrose FERIV® (20 mg/ml).” NCT01084122 ↗ |
| Known as | ferric sucrose | “intravenous iron (ferric sucrose product Venofer® 2%, 5mL/ampoule)” NCT00384657 ↗ |
| Known as | Ferumoxytol intravenous | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02499354 ↗ |
| Known as | FeS | “RBT-1 is a combination drug of stannic protoporfin (SnPP) and iron sucrose (FeS) that elicits a preconditioning response through activation of antioxidant, anti-inflammatory,...” PMID 38586479 ↗ Jan 20241“FeS (Iron Sucrose) SnPP (Stannous Protoporpyhrin” NCT03630029 ↗ |
| Known as | Iron Saccharate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00560976 ↗ |
| Known as | iron sucrose DIN 02502917 | “iron sucrose DIN 02502917” NCT05251493 ↗ |
| Known as | Iron Sucrose Injection | “Venofer (Iron Sucrose Injection)” NCT00721188 ↗ |
| Known as | iron sucrose injection - Venofer | “iron sucrose injection - Venofer” NCT00895232 ↗ |
| Known as | iron sucrose injection, USP | “iron sucrose injection, USP, 100 mg intravenously (IV) per week, for 5 weeks” NCT00534144 ↗ |
| Known as | iron(III)-hydroxide sucrose complex | “Group I (n = 54): intravenous iron(III)-hydroxide sucrose complex, three doses of 100 mg/24 h during pre- and postoperative hospitalization and 1 pill/24 h of oral placebo in...” PMID 22940889 ↗ Aug 2012 |
| Known as | IV iron | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03214627 ↗ |
| Known as | sacrofer | “Women will receive iron sucrose (sacrofer ampules 100 mg/5ml)” NCT03009578 ↗ |
| Known as | Venofer | “A Randomized Open-label Trial Cross-over Trial of Iron Isomaltoside 1000 (Monofer®) Compared With Iron Sucrose (Venofer®) in Peritoneal Dialysis Patients” NCT03610230 ↗20“500 mg iron sucrose (Venofer®, Vifor International AG, St. Gallen, Switzerland)” NCT00746551 ↗ “intravenous iron (ferric sucrose product Venofer® 2%, 5mL/ampoule)” NCT00384657 ↗ “Ferrous Sulfate, Venofer, Ferrlecit, Infed, Dexferrum” NCT00704353 ↗ “Venofer (intravenous iron sucrose)” NCT00125996 ↗ “IV Iron Saccharate (Venofer)100 mg” NCT00560976 ↗ “Venofer (iron sucrose injection)” NCT00239642 ↗ “Drug: Iron sucrose (Venofer)” NCT05734716 ↗ “iron sucrose (Venofer®)” NCT02130063 ↗ “Iron Sucrose (Venofer)” NCT00981045 ↗ “Iron sucrose = Venofer” NCT01265108 ↗ |
| Known as | Venofer (iron sucrose) | “Venofer (iron sucrose)” NCT00960921 ↗ |
| Known as | Venofer (TM) | “5 mg/kg of intravenous iron sucrose supplied as Venofer (TM) with a maximum dose of 200mg.” NCT01978535 ↗ |
| Known as | Venofer Luitpold Pharmaceuticals, NDC # 00517-2340-10 | “Venofer Luitpold Pharmaceuticals, NDC # 00517-2340-10” NCT01438372 ↗ |
| Route | Intravenous | “intravenous (IV) iron supplementation” NCT00125996 ↗ |