Drugs / Iron dextran

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) IRON DEXTRAN 1957-04-25 fda.gov

Trials 14 · a red edge is where a trial was stopped

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/22 trials
Phase 1/2 NCT07110935 Sep 2018 → Feb 2019 Federal Teaching Hospital Abakaliki Completed No outcome recorded
Phase 1/2 NCT03279536 Nov 2017 → Dec 2018 iron deficiency anemia Woman's Health University Hospital, Egypt Completed No outcome recorded
Phase 26 trials
Phase 2 NCT06508827 May 2025 → Jun 2026 iron deficiency anemia, melanoma Indiana University Withdrawn No outcome recorded
Phase 2 NCT05960227 Jan 2023 → Sep 2024 acute kidney injury, iron deficiency anemia Hospital Civil de Guadalajara Completed No outcome recorded
Phase 2 NCT05340465 Nov 2022 → Jan 2027 expected disorder of iron metabolism and transport, iron deficiency anemia University of Washington Recruiting No outcome recorded
Phase 2 NCT05167734 Nov 2021 → Mar 2024 anemia Mayo Clinic Completed No outcome recorded
Phase 2 NCT02038023 Jul 2013 → Jul 2015 pregnancy disorder Auerbach Hematology Oncology Associates P C Completed No outcome recorded
Phase 2 NCT00401544 Dec 2006 → Dec 2007 anemia, neoplasm Amgen Completed No outcome recorded
Phase 31 trial
Phase 3 NCT03212781 Jun → Sep 2016 anemia Assiut University Completed No outcome recorded
Phase 45 trials
Phase 4 NCT05714176 Feb 2023 → Jan 2024 chronic kidney disease Menoufia University Unknown No outcome recorded
Phase 4 NCT05292001 Jun 2022 → May 2026 overdue anemia Oregon Health and Science University Recruiting No outcome recorded
Phase 4 NCT05047211 Oct 2021 → Mar 2023 iron deficiency anemia The University of Texas Medical Branch, Galveston Completed No outcome recorded
Phase 4 NCT03438227 Apr 2018 → Dec 2019 disorder of mineral absorption and transport, iron deficiency anemia Indiana University Completed No outcome recorded
Phase 4 NCT02731378 Dec 2016 → Apr 2019 aregenerative anemia Shanghai East Hospital Unknown No outcome recorded
Also used as a comparator or background therapy in 10 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 24 trials
Phase 2 NCT07706582 Comparator Nov 2025 → Sep 2026 expected end stage renal failure, iron deficiency anemia Beni-Suef University Active not recruiting No outcome recorded
Phase 2 NCT01447628 Comparator Mar 2011 → Dec 2017 disorder of iron metabolism and transport, pulmonary arterial hypertension Imperial College London Completed No outcome recorded
Phase 2 NCT01307007 Comparator Sep 2010 → May 2011 iron deficiency anemia American Regent, Inc. Completed No outcome recorded
Phase 2 NCT01290315 Comparator Aug 2009 → Mar 2013 iron deficiency anemia American Regent, Inc. Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT01203514 Background Aug 1997 → Aug 1998 fetal growth restriction, neonatal anemia NICHD Neonatal Research Network Completed No outcome recorded
Phase 32 trials
Phase 3 NCT00704353 Comparator Jun 2008 → Jul 2009 anemia American Regent, Inc. Completed No outcome recorded
Phase 3 NCT00704028 Comparator Jun 2008 → Jan 2010 anemia American Regent, Inc. Completed No outcome recorded
Phase 42 trials
Phase 4 NCT02086838 Comparator Jul 2013 → Dec 2014 Ain Shams University Completed No outcome recorded
Phase 4 NCT00593619 Comparator Jan 2008 → Dec 2009 iron deficiency anemia London Health Sciences Centre Suspended No outcome recorded
Phase not applicable1 trial
NCT02889133 Comparator Jan 2017 → Oct 2021 disorder of iron metabolism and transport Columbia University Completed No outcome recorded

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 25 sources stand behind the page.

FieldValueCited text
Known as iron dextran “Patients are randomised to receive either a single dose infusion of low-molecular weight iron dextran (1000 mg) or placebo (normal saline) postoperatively during their hospital...” PMID 36944463 Mar 2023
20

“a weekly intravenous infusion of 5 mg/kg iron dextran until they had an enteral intake of 60 mL/kg/d” NCT01203514

“intravenous iron dextranNCT07110935

iron dextran (Cosmofer)” PMID 33735594 Jun 2021

NCT05960227

NCT03438227

NCT00704028

NCT05167734

NCT06508827

NCT05047211

NCT03212781

NCT01290315

NCT05714176

NCT02889133

NCT02038023

NCT01307007

NCT03279536

NCT07706582

NCT02086838

NCT00593619

NCT02731378

Known as CosmoFer ClinicalTrials.gov intervention name — accepted as the source's own label NCT01447628
Known as Dexferrum “Ferrous Sulfate, Venofer, Ferrlecit, Infed, DexferrumNCT00704353
Known as infed “Low molecular weight iron dextran (infed) 1000mg in sodium chloride 0.9% 500mL IV infusion over 1 hour preceded by test dose 25 mg IV low molecular weight iron dextran infusion...” NCT05047211
2

“single dose of 1000mg of low molecular weight iron dextran(infed).” NCT02038023

“Ferrous Sulfate, Venofer, Ferrlecit, Infed, Dexferrum” NCT00704353

Known as Iron Dextran(InFed) Iron Dextran(InFed)NCT02038023
Known as IV iron dextran ClinicalTrials.gov intervention name — accepted as the source's own label NCT00401544
Known as Low Molecular Weight Iron Dextran ClinicalTrials.gov intervention name — accepted as the source's own label NCT05340465
Route Intravenous Intravenous Iron Dextran Versus Iron Sucrose” NCT00593619