Drugs / Iron sucrose
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Iron sucrose

Developed for
anemia · iron deficiency anemia · chronic kidney disease · anemia due to chronic disorder · heart failure · acute kidney injury · disorder of iron metabolism and transport · end stage renal failure
+19 more · inflammatory bowel disease · postural orthostatic tachycardia syndrome · pulmonary hypertension · acute mountain sickness · chronic renal failure syndrome · colorectal neoplasm · critical illness polyneuropathy · female reproductive organ cancer · myalgic encephalomeyelitis/chronic fatigue syndrome · nutritional deficiency disease · osteoarthritis · osteoporosis · pregnancy disorder · restless legs syndrome · symptomatic heart failure · systolic heart failure · hematopoietic and lymphoid cell neoplasm · impaired renal function disease · puerperal disorder
Investigated by
American Regent, Inc. · University of Oxford · Assiut University · Mayo Clinic · Papageorgiou General Hospital · Renibus Therapeutics, Inc.
+57 more · Second Affiliated Hospital, School of Medicine, Zhejiang University · 4th Military Clinical Hospital with Polyclinic, Poland · Affiliated Hospital of Nanjing University of Chinese Medicine · Anemia Working Group Romania · Assistance Publique - Hôpitaux de Paris · Central Park Medical College · Cheng-Hsin General Hospital · Chiang Mai University · Children's Hospital of Michigan · Chulalongkorn University · Denver Health and Hospital Authority · Duke University · Federal University of São Paulo · First Affiliated Hospital of Chongqing Medical University · First Affiliated Hospital of Wenzhou Medical University · Fox Chase Cancer Center · Fundación Canaria Rafael Clavijo para la Investigación Biomédica · He Qifei · Hospital Aleman · Hospital Clinic of Barcelona · Hospital Universitari Vall d'Hebron Research Institute · Hospital de Clinicas de Porto Alegre · Indiana University · J. Uriach and Company · Kaohsiung Medical University Chung-Ho Memorial Hospital · Konkuk University Medical Center · Kunshan First People's Hospital Affiliated to Jiangsu University · Mahidol University · Melbourne Health · Muhammad Aamir Latif · National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov · National Heart and Lung Institute · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · National Institute on Aging (NIA) · Richard Fedorak · Ruijin Hospital · Seoul National University Bundang Hospital · Sindh Institute of Urology and Transplantation · Soroka University Medical Center · Sundsvall Hospital · Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University · The Central Hospital of Lishui City · The Fourth Affiliated Hospital of Zhejiang University School of Medicine · The Guthrie Clinic · The University of Hong Kong · Unity Health Toronto · Universidad Peruana Cayetano Heredia · University Hospital Muenster · University of Oregon · University of Saskatchewan · University of Zurich · Vifor Pharma · Watson Pharmaceuticals · Wayne State University · Wexham Park Hospital · Zhejiang Provincial People's Hospital · Zhejiang University

Regulatory milestones approvals, filings & regulatory actions · 5 recorded

MilestoneJurisdictionBrandIndicationDateSentence 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 62

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT03630029 Sep → Nov 2018 acute kidney injury Renibus Therapeutics, Inc. Withdrawn No outcome recorded
Phase 1 NCT01265108 Nov 2010 → Jan 2015 — University of Oxford Completed No outcome recorded
Phase 1/22 trials · 1 missed
Phase 1/2 NCT01978535 Dec 2014 → Sep 2017 postural orthostatic tachycardia syndrome Mayo Clinic Terminated No outcome recorded Stop: Enrollment
Phase 1/2 NCT00125996 Jul 2004 → Feb 2006 iron deficiency anemia, symptomatic heart failure National Heart and Lung Institute Unknown Missed primary
Phase 212 trials · 1 met primary
Phase 2 NCT05800600 Mar 2023 → Feb 2027 expected anemia Fox Chase Cancer Center Recruiting No outcome recorded
Phase 2 NCT04564833 Aug 2021 → Nov 2022 acute kidney injury Renibus Therapeutics, Inc. Completed Met primary
Phase 2 NCT04855266 Apr 2021 → May 2023 iron deficiency anemia, postural orthostatic tachycardia syndrome Mayo Clinic Withdrawn No outcome recorded Stop: Enrollment
Phase 2 NCT03528564 Jul 2019 → May 2021 anemia due to chronic disorder, arthropathy, iron deficiency anemia Unity Health Toronto Terminated No outcome recorded
Phase 2 NCT02977611 Jan → May 2017 iron deficiency anemia The Guthrie Clinic Withdrawn No outcome recorded
Phase 2 NCT02047552 Jan 2015 → Dec 2017 anemia, disorder of iron metabolism and transport Denver Health and Hospital Authority Withdrawn No outcome recorded Stop: Enrollment
Phase 2 NCT01438372 Nov 2011 → Feb 2012 inflammatory bowel disease, iron deficiency anemia Wayne State University Withdrawn No outcome recorded Stop: Enrollment
Phase 2 NCT01309659 May 2011 → Feb 2013 anemia Duke University Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT00721188 Jan 2006 → Jul 2008 anemia American Regent, Inc. Completed No outcome recorded
Phase 2 NCT00895232 Nov 2003 → Aug 2005 restless legs syndrome American Regent, Inc. Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT00386126 Aug 2006 → ? anemia, heart failure Hospital de Clinicas de Porto Alegre Unknown No outcome recorded
Phase 311 trials · 2 met primary · 1 missed
Phase 3 NCT06248749 Feb 2024 → Dec 2028 expected anemia University of Saskatchewan Not yet recruiting No outcome recorded
Phase 3 NCT04464850 Jul 2020 → Jan 2021 iron deficiency anemia Chiang Mai University Unknown No outcome recorded
Phase 3 NCT03009578 Feb 2017 → Apr 2018 anemia Assiut University Completed No outcome recorded
Phase 3 NCT01857011 Apr 2014 → Apr 2016 iron deficiency anemia Federal University of São Paulo Completed Missed primary
Phase 3 NCT01435200 Jun 2011 → Oct 2012 female reproductive organ cancer Chulalongkorn University Completed Met primary
Phase 3 NCT00384657 Jan 2008 → Dec 2017 anemia, chronic kidney disease, heart failure Anemia Working Group Romania Withdrawn No outcome recorded Stop: Business
Phase 3 NCT00202345 Aug 2004 → Feb 2007 anemia, kidney failure Melbourne Health Completed No outcome recorded
Phase 3 NCT00145652 Dec 2003 → Dec 2005 B-cell chronic lymphocytic leukemia, anemia, plasma cell myeloma Sundsvall Hospital Completed No outcome recorded
Phase 3 NCT00236977 Aug 2003 → Oct 2004 anemia American Regent, Inc. Completed Met primary
Phase 3 NCT00236938 Jul 2002 → Sep 2004 anemia American Regent, Inc. Completed No outcome recorded
Phase 421 trials · 2 missed
Phase 4 NCT06703411 May 2023 → Oct 2024 disorder of iron metabolism and transport, systolic heart failure Cheng-Hsin General Hospital Completed No outcome recorded
Phase 4 NCT05489952 Sep 2022 → Feb 2025 osteoporosis He Qifei Unknown No outcome recorded
Phase 4 NCT05734716 Feb 2021 → Aug 2022 acute mountain sickness University of Oregon Completed No outcome recorded
Phase 4 NCT02787824 May → Oct 2016 anemia due to chronic disorder Papageorgiou General Hospital Completed No outcome recorded
Phase 4 NCT02544828 Nov 2015 → Jul 2016 osteoarthritis Konkuk University Medical Center Unknown No outcome recorded
Phase 4 NCT02390921 Feb → Oct 2015 iron metabolism disease Hospital Universitari Vall d'Hebron Research Institute Completed No outcome recorded
Phase 4 NCT02060851 Feb → Jun 2014 nutritional deficiency disease Kunshan First People's Hospital Affiliated to Jiangsu University Completed No outcome recorded
Phase 4 NCT01084122 May 2010 → Dec 2012 — Hospital Clinic of Barcelona Unknown No outcome recorded
Phase 4 NCT01067547 Mar 2010 → Dec 2013 inflammatory bowel disease, iron deficiency anemia Richard Fedorak Completed No outcome recorded
Phase 4 NCT00746551 Sep 2008 → Mar 2010 anemia, pregnancy disorder Mahidol University Completed No outcome recorded
Phase not applicable12 trials
— NCT06994065 Apr → Sep 2025 iron deficiency anemia Sindh Institute of Urology and Transplantation Completed No outcome recorded
— NCT07115121 Feb → Jul 2025 anemia Muhammad Aamir Latif Completed No outcome recorded
— NCT06012760 Jan 2025 → Jan 2028 expected iron deficiency anemia Second Affiliated Hospital, School of Medicine, Zhejiang University Recruiting No outcome recorded
— NCT05353348 Mar 2023 → Apr 2025 overdue iron deficiency anemia Second Affiliated Hospital, School of Medicine, Zhejiang University Recruiting No outcome recorded
— NCT06596161 Feb 2023 → Feb 2024 myalgic encephalomeyelitis/chronic fatigue syndrome Central Park Medical College Completed No outcome recorded
— NCT04491916 Apr 2020 → Dec 2022 anemia, end stage renal failure Kaohsiung Medical University Chung-Ho Memorial Hospital Unknown No outcome recorded
— NCT03610230 Feb 2019 → Mar 2021 iron deficiency anemia The University of Hong Kong Terminated No outcome recorded Stop: Enrollment
— NCT03516500 May 2018 → Jan 2021 lung neoplasm Ruijin Hospital Completed No outcome recorded
— NCT01443624 Oct 2011 → Jan 2013 critical illness polyneuropathy Assistance Publique - Hôpitaux de Paris Completed No outcome recorded
— NCT00952302 Oct → Nov 2008 chronic mountain sickness, pulmonary hypertension University of Oxford Completed Mixed
Phase not stated1 trial
— NCT05151679 — iron deficiency anemia Assiut University Available No outcome recorded
Comparator or background therapy38 trials
Phase 1 NCT02009943 Comparator Feb → Aug 2017 anemia, disorder of iron metabolism and transport Denver Health and Hospital Authority Withdrawn No outcome recorded Stop: Business
Phase 1 NCT00534144 Comparator Sep 2007 → Nov 2008 chronic renal failure syndrome, iron deficiency anemia Watson Pharmaceuticals Completed No outcome recorded
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 NCT01052779 Comparator Mar 2010 → Jul 2011 anemia, disorder of iron metabolism and transport, kidney disorder AMAG Pharmaceuticals, Inc. Completed No outcome recorded

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2025-08-11 Pfizer's Upjohn has merged with Mylan to form Viatris Inc. Regulatory Viatris Announces Approval of First Generic Iron Sucrose Injection in the U.S. viatris.com ↗
Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced the U.S. Food and Drug Administration (FDA) has approved Iron Sucrose Injection, USP, an intravenous iron replacement product used to treat iron deficiency anemia (IDA) in adult and pediatric patients (2 years of age and older) with chronic kidney disease (CKD).
2025-08-11 Amphastar Pharmaceuticals, Inc. Regulatory Amphastar Announces FDA Approval for Iron Sucrose Injection, USP amphastar.com ↗
2019-01-22 CSL Behring Results Vifor Pharma Press Release Updated on Analysis of Venofer in High Dosage Study csl.com ↗
The re-analysis of the data revealed a statistically significant improvement in the treatment effects of a higher dose of Venofer® (i.v. iron sucrose) compared with a lower dose.
2018-10-29 CSL Behring Results Pivotal trial confirms long-term safety and efficacy of IV iron dosing strategy csl.com ↗
The trial met its primary endpoint of noninferiority as assessed by a composite of death and cardiovascular events, demonstrating that a liberal, proactive intravenous (IV) iron dosing regimen did not expose patients to an increased level of harm

Evidence & citations 16 cited values

Every value below carries the sentence it was read from. 101 sources stand behind the page.

FieldValueCited 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 2024
88

“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 ↗

“The study group received 200mg of intravenous iron sucrose immediately after each chemotherapy infusion.” PMID 24099839 ↗ Oct 2013

“Iron sucrose will be given by continuous infusion for 1 hour during the last 1 hour of dialysis session.” NCT04464850 ↗

“Iron Sucrose, Iron Gluconate or Iron Isomaltoside (Treatment group A) versus No Iron Infusion treatment” NCT06248749 ↗

“5 mg/kg of intravenous iron sucrose supplied as Venofer (TM) with a maximum dose of 200mg.” NCT01978535 ↗

“5 mg/kg of intravenous iron sucrose (maximum dose of 200 mg). Iron sucrose will be diluted” NCT04855266 ↗

“500 mg iron sucrose (Venofer®, Vifor International AG, St. Gallen, Switzerland)” NCT00746551 ↗

Show 78 more sources

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 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 2024
1

“FeS (Iron Sucrose) SnPP (Stannous Protoporpyhrin” NCT03630029 ↗

Known as Iron saccharate ClinicalTrials.gov intervention name — accepted as the source's own label NCT00557817 ↗
1

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 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 ↗

“IV Iron Saccharate (Venofer)100 mg” NCT00560976 ↗

“Venofer (intravenous iron sucrose)” NCT00125996 ↗

“Venofer (iron sucrose injection)” NCT00239642 ↗

“Drug: Iron sucrose (Venofer)” NCT05734716 ↗

“iron sucrose (Venofer®)” NCT02130063 ↗

“Iron sucrose = Venofer” NCT01265108 ↗

“Iron Sucrose (Venofer)” NCT00981045 ↗

Show 10 more sources

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 ↗