Drugs / Ferrous Sulfate
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Ferrous Sulfate

Diagnostic / imaging agent

Developed for
iron deficiency anemia · anemia · disorder of iron metabolism and transport · pregnancy disorder · chronic kidney disease · Crohn disease · heart failure · inflammatory bowel disease
+26 more · iron metabolism disease · ulcerative colitis · anemia due to chronic disorder · aregenerative anemia · craniosynostosis · hereditary hemorrhagic telangiectasia · insomnia · lead poisoning · schistosomiasis · systolic heart failure · X-linked erythropoietic protoporphyria · chemotherapy-induced toxicity · chronic renal failure syndrome · cognitive impairment with or without cerebellar ataxia · colon carcinoma · colorectal carcinoma · cystic fibrosis · deficiency anemia · diastolic heart failure · microcytic anemia · myocardial infarction · periodic limb movement disorder · post-surgical hypoinsulinemia · postgastrectomy syndrome · restless legs syndrome · uterine disorder
Investigated by
Baylor College of Medicine · GlaxoSmithKline · Rockwell Medical Technologies, Inc. · University of Ulm · Watson Pharmaceuticals · Weill Medical College of Cornell University
+78 more · Academic Medical Center - University of Amsterdam · Academy of Finland · AdventHealth · Ain Shams Maternity Hospital · Akebia Therapeutics · Astellas Pharma Inc · Autism Treatment Network · Build Healthy India Movement · Centers for Disease Control and Prevention · Chengdu Maternal and Children's Health Care Hospital · Children's Hospital of Philadelphia · Cornell University · Crohn's and Colitis Foundation · DBL -Institute for Health Research and Development · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · FHI 360 · Federal University of Goiás · Federal University of São Paulo · Fluminense Federal University · Ghana Health Services · Goiania Municipal Health Department · Health Resources and Services Administration (HRSA) · Hospital de Clinicas de Porto Alegre · Icahn School of Medicine at Mount Sinai · Imperial College London · Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri · Iowa State University · Istanbul University - Cerrahpasa · Kyntra Bio · Leiden University Medical Center · Liverpool University Hospitals NHS Foundation Trust · Luzerner Kantonsspital · Maastricht University Medical Center · Martini Hospital Groningen · Massachusetts General Hospital · Ministry of Health, Brazil · Ministry of Science and Technology, India · National Cardiovascular Center Harapan Kita Hospital Indonesia · National Heart, Lung, and Blood Institute (NHLBI) · National Institute for Health and Welfare, Finland · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Netherlands Overseas Agency · Pakistan Air Force (PAF) Hospital Islamabad · Peterborough Hospitals Hip Fracture Project · Peterborough and Stamford Hospitals NHS Foundation Trust · Phramongkutklao College of Medicine and Hospital · Pierre Fabre Laboratories · Prince of Songkla University · Queen Mary University of London · Radboud University Medical Center · Sao Jose do Rio Preto Medical School · Shahida Islam Medical Complex · Shengjing Hospital · Southern Illinois University · Southern Medical University, China · Stony Brook University · Sunnybrook Health Sciences Centre · Swiss Federal Institute of Technology · Swiss National Science Foundation · Swiss Tropical & Public Health Institute · Texas Tech University · The Emmes Company, LLC · The Thai Society of Hematology · The University of Texas Health Science Center, Houston · The University of Texas Medical Branch, Galveston · Thrasher Research Fund · Unity Health Toronto · University Health Network, Toronto · University Hospital, Montpellier · University Medical Center Groningen · University of Child Health Sciences and Children's Hospital, Lahore · University of Colorado, Denver · University of Missouri-Columbia · University of North Texas Health Science Center · all 84 on the full record

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) FOLVRON — 1946-08-13 fda.gov ↗

Trials 59

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT02767128 Apr 2016 IRIDA syndrome Rockwell Medical Technologies, Inc. Completed No outcome recorded
Phase 1 NCT02327546 Dec 2014 — Akebia Therapeutics Completed No outcome recorded
Phase 1 NCT01757119 Jan 2013 → Mar 2014 iron deficiency anemia Pierre Fabre Laboratories Completed No outcome recorded
Phase 1 NCT01762995 Dec 2012 → Mar 2013 HIV infectious disease ViiV Healthcare Completed No outcome recorded
Phase 29 trials · 2 missed
Phase 2 NCT05544513 Aug 2022 → Dec 2026 expected anemia due to chronic disorder, chronic kidney disease, immune dysregulation, neurodevelopmental defects, and colitis, iron deficiency anemia Fluminense Federal University Active not recruiting No outcome recorded
Phase 2 NCT03457701 Jul 2019 → Jul 2022 anemia GlaxoSmithKline Completed Missed primary
Phase 2 NCT03481790 Sep 2017 → Mar 2018 iron deficiency anemia Ain Shams Maternity Hospital Completed No outcome recorded
Phase 2 NCT02905981 Jan 2017 → Mar 2018 IRIDA syndrome Rockwell Medical Technologies, Inc. Terminated No outcome recorded
Phase 2 NCT01745497 Dec 2012 → Aug 2015 autism spectrum disorder, insomnia University of Colorado, Denver Completed No outcome recorded
Phase 2 NCT01414075 Jul 2011 → Jan 2013 anemia Kyntra Bio Completed Missed primary
Phase 2 NCT00374790 Oct 2006 → May 2008 lead poisoning Cornell University Completed No outcome recorded
Phase 2 NCT00450177 Jan 2006 → Dec 2007 aregenerative anemia Weill Medical College of Cornell University Completed No outcome recorded
Phase 2 NCT00152841 Jun 2002 → Feb 2009 Crohn disease, anemia, ulcerative colitis University Health Network, Toronto Terminated No outcome recorded
Phase 2/33 trials · 1 met primary
Phase 2/3 NCT02998697 Jan → Oct 2016 iron deficiency anemia, systolic heart failure National Cardiovascular Center Harapan Kita Hospital Indonesia Completed Met primary
Phase 2/3 NCT00386126 Aug 2006 → ? anemia, heart failure Hospital de Clinicas de Porto Alegre Unknown No outcome recorded
Phase 2/3 NCT00223977 Dec 2003 → Nov 2004 iron deficiency anemia Watson Pharmaceuticals Completed No outcome recorded
Phase 310 trials · 2 missed
Phase 3 NCT07661602 Jul → Aug 2026 overdue anemia Southern Medical University, China Not yet recruiting No outcome recorded
Phase 3 NCT07708025 Sep 2025 → Feb 2026 anemia, heart failure University of Porto Completed No outcome recorded
Phase 3 NCT07267975 Jan → Mar 2025 iron deficiency anemia University of Child Health Sciences and Children's Hospital, Lahore Completed No outcome recorded
Phase 3 NCT06321887 Oct 2023 → Oct 2024 inflammatory bowel disease, iron deficiency anemia Liverpool University Hospitals NHS Foundation Trust Unknown No outcome recorded
Phase 3 NCT04371536 Jul 2021 → Feb 2022 iron deficiency anemia Baylor College of Medicine Completed No outcome recorded
Phase 3 NCT04130828 Jan 2020 → Jan 2022 iron deficiency anemia Prince of Songkla University Completed No outcome recorded
Phase 3 NCT03725384 Jan 2019 → Jan 2022 iron deficiency anemia Sunnybrook Health Sciences Centre Completed No outcome recorded
Phase 3 NCT00364104 Mar 2007 → Dec 2008 iron metabolism disease The University of Texas Health Science Center, Houston Completed Missed primary
Phase 3 NCT00136266 Mar → Dec 2005 iron deficiency anemia Centers for Disease Control and Prevention Completed Missed primary
Phase 3 NCT00919230 Jul 2004 → Jul 2009 — Peterborough and Stamford Hospitals NHS Foundation Trust Completed No outcome recorded
Phase 412 trials · 1 met primary
Phase 4 NCT06492512 May 2025 → Jul 2028 expected iron deficiency anemia, pregnancy disorder Southern Illinois University Recruiting No outcome recorded
Phase 4 NCT06238895 Mar 2024 → Nov 2025 iron deficiency anemia, iron metabolism disease Luzerner Kantonsspital Completed No outcome recorded
Phase 4 NCT05456932 Aug 2022 → Aug 2023 disorder of iron metabolism and transport, inflammatory bowel disease, iron deficiency anemia Leiden University Medical Center Unknown No outcome recorded
Phase 4 NCT05278793 Jan → Dec 2022 iron deficiency anemia, pregnancy disorder Martini Hospital Groningen Unknown No outcome recorded
Phase 4 NCT04975074 Jul → Dec 2021 iron deficiency anemia Shengjing Hospital Unknown No outcome recorded
Phase 4 NCT05007899 Dec 2020 → Jun 2022 iron deficiency anemia Baylor College of Medicine Completed No outcome recorded
Phase 4 NCT04594070 Oct 2020 → Jan 2024 iron deficiency anemia, pregnancy disorder The University of Texas Medical Branch, Galveston Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT03991169 Apr 2019 → Dec 2028 expected chronic kidney disease Weill Medical College of Cornell University Recruiting No outcome recorded
Phase 4 NCT03359447 Aug 2017 → Mar 2019 iron deficiency anemia Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri Unknown No outcome recorded
Phase 4 NCT01991314 Dec 2011 → Jun 2015 Crohn disease, ulcerative colitis Queen Mary University of London Completed No outcome recorded
Phase not applicable21 trials · 1 missed
— NCT07657455 Sep → Dec 2026 expected iron deficiency anemia Pakistan Air Force (PAF) Hospital Islamabad Not yet recruiting No outcome recorded
— NCT07816601 May 2026 → Nov 2027 expected iron deficiency anemia AdventHealth Recruiting No outcome recorded
— NCT07263529 Sep 2025 → Jan 2026 overdue disorder of iron metabolism and transport Istanbul University - Cerrahpasa Recruiting No outcome recorded
— NCT07014371 Jun 2025 → Dec 2027 expected iron deficiency anemia Phramongkutklao College of Medicine and Hospital Recruiting No outcome recorded
— NCT07340450 Feb → Aug 2025 — Shahida Islam Medical Complex Completed No outcome recorded
— NCT05233956 Oct 2023 → Dec 2026 expected anemia FHI 360 Active not recruiting No outcome recorded
— NCT05423249 Aug 2022 → Nov 2024 disorder of iron metabolism and transport Stony Brook University Completed No outcome recorded
— NCT03231085 Oct 2017 → Apr 2024 craniosynostosis University Hospital, Montpellier Completed No outcome recorded
— NCT02979249 Dec 2016 → Jul 2019 X-linked erythropoietic protoporphyria Icahn School of Medicine at Mount Sinai Completed No outcome recorded
— NCT02839096 Jun 2016 → Jun 2019 iron deficiency anemia University of Missouri-Columbia Terminated No outcome recorded Stop: Business
Comparator or background therapy100 trials
Phase 0 NCT05349630 Comparator Mar 2028 → Dec 2029 expected — University of Colorado, Denver Not yet recruiting No outcome recorded
Phase 0 NCT02005588 Comparator Dec 2013 → Jun 2015 iron deficiency anemia Cairo University Completed No outcome recorded
Phase 1 NCT00535561 Comparator Jun → Sep 2007 hypothyroidism, iron deficiency anemia Duzce University Completed No outcome recorded
Phase 1 NCT00867867 Comparator Oct 2003 → Jun 2008 Helicobacter pylori infectious disease International Centre for Diarrhoeal Disease Research, Bangladesh Completed No outcome recorded
Phase 1/2 NCT03484845 Comparator Nov 2018 → Dec 2019 iron deficiency anemia Assiut University Unknown No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2026-07-28 Shield Therapeutics Results Shield Therapeutics - ACCRUFeR® Phase 3 pediatric trial published shieldtherapeutics.com ↗
2025-10-01 Shield Therapeutics Results Shield Therapeutics - Positive efficacy and tolerance in pediatric trial shieldtherapeutics.com ↗
Clinically and statistically significant Hb improvements vs. baseline were observed across all groups (ferric maltol arms and ferrous sulfate arm (P<0.0001)

All press releases naming this drug 2 releases

DateIssuerRelease

Evidence & citations 23 cited values

Every value below carries the sentence it was read from. 162 sources stand behind the page.

FieldValueCited text
Known as ferrous sulfate “The purpose of the study was to compare the efficacy of oral iron (ferrous sulfate) plus erythropoietin to Iron Sucrose plus erythropoietin for managing anemia patients with...” NCT00236964 ↗
91

“In the standard iron-folic acid supplementation group, participants diagnosed with iron deficiency anemia will receive ferrous sulfate tablets providing 60 mg of elemental iron...” NCT07661602 ↗

“Drug: FerroGrad by Abbott Dosage: one capsule three times /day containing150 mg of dried ferrous sulfate capsules (Ferrofol capsules, Eipico, Egypt), with placebo sachets.” NCT03202615 ↗

“oral ferrous iron preparations (ferrous sulfate), each providing 160 mg elemental iron once daily, administered on an empty stomatch with 200 mg vitamin c for 3 months.” NCT07366502 ↗

“either hydroxide polymaltose \[Ferrum Haussman®\] or ferrous sulfate \[Ferro Gradumet®\]” NCT07708025 ↗

“Oral iron supplementation with ferrous sulfate has been considered the standard of care” NCT03957057 ↗

“Ca. 200-300 mg of ferrous sulfate will be administered orally every day for 3 months.” NCT05060731 ↗

“Group II received ferrous sulfate (element Fe 1-2 mg/kg•day) once a day for 6 months” NCT01355263 ↗

“Participants given tablet Ferrous sulfate, 325 mg orally three times a day.” NCT07340450 ↗

“40 doses of 30 mg of ferrous sulfate during a 10-month intervention period” NCT00992823 ↗

“Oral ferrous sulfate 325 mg twice daily was administered for 12 months.” PMID 36406817 ↗ Nov 2022

Show 81 more sources

Known as Dried Ferrous Sulfate ClinicalTrials.gov intervention name — accepted as the source's own label NCT05299411 ↗
Known as Eisen-II-Sulfat “Oral iron supplementation with Eisen-II-Sulfat (Tardyferon ®) Every second day 2 x 80 mg Tardyferon® for a duration of 12 weeks.” NCT06238895 ↗
Known as FeFum “a complementary food (CF) fortified with sodium iron EDTA (NaFeEDTA) plus either ferrous fumarate (FeFum) or ferric pyrophosphate (FePP)” PMID 28708072 ↗ Jul 2017
Known as Fer-In-Sol ClinicalTrials.gov intervention name — accepted as the source's own label NCT02905981 ↗
1

NCT02767128 ↗

Known as Ferli-6 “3 ferrous fumarate tablets (Ferli-6®) everyday” NCT00746551 ↗
Known as Feroba-YOU “Ferrous sulfate(Feroba-YOU) per oral” NCT03229954 ↗
Known as Ferro Gradumet “either hydroxide polymaltose \[Ferrum Haussman®\] or ferrous sulfate \[Ferro Gradumet®\]” NCT07708025 ↗
Known as FerroGrad “Drug: FerroGrad by Abbott Dosage: one capsule three times /day containing150 mg of dried ferrous sulfate capsules (Ferrofol capsules, Eipico, Egypt), with placebo sachets.” NCT03202615 ↗
Known as Ferrous fumarate “LNG/ethinyl estradiol (EE)/ferrous fumarate combined oral contraceptive (COC) regimen” NCT05233956 ↗
32

“patients are randomized to 300 mg of ferrous fumarate or placebo for 4 weeks” NCT00152841 ↗

“Calcium Carbonate 150 mg/day Ferrous Fumarate 27 mg/day Zinc Oxide 25 mg/day” NCT02620345 ↗

“3 ferrous fumarate tablets (Ferli-6®) everyday” NCT00746551 ↗

“ferrous fumarate or ferrous gluconate” NCT01414075 ↗

“Ferrous fumarate” NCT01155375 ↗

NCT05581420 ↗

NCT01634945 ↗

NCT00136266 ↗

NCT07014371 ↗

NCT06321887 ↗

Show 22 more sources

Known as ferrous succinate “Other drugs to treat anemia include: Recombinant human eythropoietin (RH-EPO), iron agents (ferrous succinate, polysaccharide iron complex, iron sucrose, etc.)” NCT05691257 ↗
7

“If necessary, oral ferrous succinate, vitamins B12 and folic acid will be administered.” NCT03010579 ↗

“ferrous succinate” NCT04975074 ↗

NCT03891277 ↗

NCT05784870 ↗

NCT05714007 ↗

NCT06830941 ↗

NCT02631668 ↗

Known as ferrous sulphate “Directly Observed Home based Daily Iron( ferrous sulphate) therapy (DOHBIT) will be provided to the anemic women by the local village volunteers.” NCT01129843 ↗
31

“200 mg of dried ferrous sulphate tablet once daily for 30 days on empty stomach but may be taken with meals to avoid stomach upset” NCT03759353 ↗

“after single oral administration of 2 tablets of L0008 80 mg (as ferrous sulphate) in women with iron deficiency anaemia.” NCT01757119 ↗

“The pregnant women randomized to the control arm (FS) will be given one 200mg tablet of ferrous sulphate” NCT04976179 ↗

“oral ferrous sulphate 325 mg thrice daily for a total of 195 mg elemental iron daily for 56 days” PMID 20929915 ↗ Oct 2010

“Routine group: 60 mg per day of ferrous sulphate (combination with folic acid) daily.” NCT00488579 ↗

“either oral Ferrous Sulphate (FS) 200 mg three times a day or placebo” PMID 36578916 ↗ Nov 2022

“ferrous sulphate oral in the form of syrup” NCT06176430 ↗

“oral iron(ferrous Sulphate)” NCT07110935 ↗

NCT01701310 ↗

NCT01628770 ↗

Show 21 more sources

Known as Ferrous sulphate tablets “Drug: Ferrous sulphate tablets” NCT00919230 ↗
Known as FeSO(4) “ferrous sulfate (FeSO(4)) 325 mg orally thrice daily for 6 weeks.” PMID 17666600 ↗ Aug 2007
Known as Hema-caps “75 pregnant women will recommended to take ferrous fumarate e.g. Hema-caps (ferrous fumarate 350 mg with elemental iron 115mg) prepared by another egyptian pharmaceutical...” NCT03830034 ↗
Known as Iron “Iron (ferrous sulfate)” NCT00459225 ↗
Known as L0008 “after single oral administration of 2 tablets of L0008 80 mg (as ferrous sulphate)” NCT01757119 ↗
Known as Oral Iron “Oral Iron (Ferrous sulphate)” NCT07659184 ↗
Known as Tardyfer “ferrous sulphate (Tardyfer®) 160 mg daily for 6 weeks” NCT03957057 ↗
Known as Tardyferon “Oral iron supplementation with Eisen-II-Sulfat (Tardyferon ®) Every second day 2 x 80 mg Tardyferon® for a duration of 12 weeks.” NCT06238895 ↗
Known as Upsher-Smith ferrous sulfate 325 mg tablets NDC# 00245-0108-11 “Upsher-Smith ferrous sulfate 325 mg tablets NDC# 00245-0108-11” NCT01438372 ↗
Modality Diagnostic / imaging agent “For assessment of incorporation of iron into erythrocytes, participants will be administered ferrous sulfate containing a stable isotope of iron (57Fe) orally” NCT03457701 ↗
Route Oral “Oral Iron” NCT00223938 ↗