CDEK
← All drugs Report issue

ferrous sulfate

Small moleculeapproved

Approved

Aug 13, 1946

Iron(II) sulfate or ferrous sulfate (British English: sulphate instead of sulfate) denotes a range of salts with the formula FeSO4·xH2O. These compounds exist most commonly as the heptahydrate (x = 7), but several values for x are known. The hydrated form is used medically to treat or prevent iron deficiency, and also for industrial applications. Known since ancient times as copperas and as green vitriol (vitriol is an archaic name for hydrated sulfate minerals), the blue-green heptahydrate (hydrate with 7 molecules of water) is the most common form of this material. All the iron(II) sulfates dissolve in water to give the same aquo complex [Fe(H2O)6]2+, which has octahedral molecular geometry and is paramagnetic. The name copperas dates from times when the copper(II) sulfate was known as blue copperas, and perhaps in analogy, iron(II) and zinc sulfate were known respectively as green and white copperas. — Wikipedia

Clinical trial activity

171 trials · 186 clinical orgs · 2 marketing orgs

Phase 1
9
Phase 2
54
Phase 3
39
Phase 4
36

Earliest trial started Feb 1, 1995 (NCT00497471)

Timeline

1940s

  1. Aug 13, 1946

    American Cyanamid — Earliest FDA Approval

  2. Aug 13, 1946

    Lederle — NDA Secondary Org

  3. Aug 13, 1946

    American Cyanamid — NDA Secondary Org

  4. Aug 13, 1946

    American Cyanamid — NDA Organization

2000s

  1. Jan 1, 2001

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2004

    Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2004

    Earliest Phase 2 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

  • IronSupplementation

    Iron supplementation

Combination products

Approval history

  • approvedAug 13, 1946

Chemistry & pharmacology

Loading structure…

SMILES

[Fe+2].[O-]S(=O)(=O)[O-]
Mol. weight
151.91 g/mol
Chirality
Achiral Molecule
Inorganic
Yes
Polymer
No
Delivery
Oral
Availability
Discontinued

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • aktiferrin
  • apo-ferrous sulfate
  • biofer
  • biofer
  • biofer
  • ceferro
  • conferon
  • eisendragees-ratiopharm
  • eisenkapseln intermuti
  • eisensulfat stada
  • fe-cap
  • feosol
  • feosol
  • feospan
  • feospan
  • feospan
  • feratab
  • fer-gen-sol
  • fer-in-sol
  • fer-in-sol
  • fer-in-sol
  • ferodan
  • ferogradumet
  • fero-gradumet
  • fero-gradumet
  • fero-gradumet
  • ferrocontin
  • ferrocontin continus
  • ferrocontin continus
  • ferrocontin continus
  • ferrogamma
  • ferroglycine sulfate
  • ferrograd
  • ferrograd
  • ferrograd
  • ferrograd
  • ferro-gradumet
  • ferroinfant
  • ferro sanol
  • ferrous glycine sulfate
  • ferrous glycine sulfate
  • ferrous glycine sulfate
  • ferrous glycine sulphate
  • ferrous sulfate
  • ferrous sulfate
  • ferrous sulfate
  • ferrous sulfate
  • ferrous sulfate
  • ferrous sulfate
  • ferrous sulfate
  • ferrous sulfate, dried
  • ferrous sulfate glycine complex
  • ferrous sulfate, heptahydrate
  • ferrous sulphate
  • ferrous sulphate
  • ferrous sulphate
  • ferr sulf, dried
  • glutaferro gotas
  • glycine-ferrous sulfate complex
  • haemoprotect
  • hämatopan
  • hemobion
  • hemofer
  • ionic iron
  • iron(ii) sulfate heptahydrate
  • kelferon
  • kendural
  • mol-iron
  • mol-iron
  • mol-iron
  • monsels solution
  • natabec
  • plastufer
  • plesmet
  • plesmet
  • plesmet
  • slow-fe
  • slow-fe
  • slow-fe
  • sulfuric acid, iron(2+) salt (1:1)
  • vitaferro kapseln

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07061470Phase 1/Phase 2 (Phase 2)Mar 1, 2026Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
NCT06884280Phase 3Oct 31, 2025Hull University Teaching Hospitals NHS Trust, Pharmacosmos
NCT07263529N/ASep 1, 2025Istanbul University
NCT06942208N/ASep 1, 2025Mitacs, Natural Sciences and Engineering Research Council, Canada, University of Calgary
NCT07081152N/AJul 24, 2025North-West University, University of London, University of Zurich
NCT07053475Phase 4Apr 2, 2025American Regent, Inc., Western Kentucky Heart and Lung Research Foundation and Educational Trust
NCT06851130N/AFeb 25, 2025Swiss Federal Institute of Technology
NCT07267975Phase 3Jan 7, 2025University of Child Health Sciences and Children's Hospital, Lahore
NCT06742528N/AJan 10, 2024Khyber Medical University Peshawer
NCT06176430Phase 4Jan 1, 2024Shaheed Zulfiqar Ali Bhutto Medical University
NCT06042699N/ADec 1, 2023Columbia University, National Institute of General Medical Sciences (NIGMS)
NCT06366698Phase 3Nov 21, 2023University of California, Irvine
NCT07078630N/AOct 5, 2023University of Westminster
NCT05985070N/AJul 17, 2023Liaquat University of Medical & Health Sciences
NCT05299411Phase 2Apr 20, 2023Korea University, Pharmbio Korea
NCT05349630Early Phase 1 (Phase 1)Jan 31, 2023University of Colorado, Denver
NCT05304442Phase 3Sep 30, 2022Baylor University, Pharmacosmos
NCT05423249N/AAug 12, 2022Stony Brook University
NCT05462704Phase 3Aug 1, 2022Brown University, Oregon Health and Science University, University of Alabama, Birmingham, University of Michigan, University of Utah, Washington University in St. Louis
NCT05544513Phase 2Aug 1, 2022Fluminense Federal University
Showing 20 of 171 trials
Page 1 / 9

Organizations

Research & Development (186)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Swiss Federal Institute of TechnologyAcademic/Hospital171712009
Daiichi SankyoFor profit11932001
University of LondonAcademic/Hospital7442004
University of ZurichAcademic/Hospital7022009
AMAG Pharmaceuticals, Inc.For profit6142011
Cornell UniversityAcademic/Hospital5532000
National Institutes of Health (NIH)Government5322001
Baylor UniversityAcademic/Hospital4322007
Iowa State UniversityAcademic/Hospital4412013
Ain Shams UniversityAcademic/Hospital3322017
Auerbach Hematology and OncologyAcademic/Hospital3232014
Columbia UniversityAcademic/Hospital3212009
J. W. Goethe UniversityAcademic/Hospital3322015
PharmacosmosFor profit3022021
Pierre FabreFor profit3222008
University of MichiganAcademic/Hospital3032008
University of Sao PauloAcademic/Hospital3122005
Vifor Inc.For profit3222009
Watson PharmaceuticalsFor profit3322003
Antistress AGFor profit2012018
186 organizations
Page 1 / 10

Marketing (3)

OrganizationOrg typeRelationshipDate
American CyanamidFor profitNDA2Aug 13, 1946
American CyanamidFor profitNDAAug 13, 1946
LederleFor profitNDA2Aug 13, 1946