magnesium sulfate

Trade name: Tis-U-Sol

Small moleculeapproved

Approved

Oct 6, 1981

Magnesium sulfate or magnesium sulphate is a chemical compound, a salt with the formula MgSO4, consisting of magnesium cations Mg2+ (20.19% by mass) and sulfate anions SO2−4. It is a white crystalline solid, soluble in water. — Wikipedia

Clinical trial activity

435 trials · 296 clinical orgs · 29 marketing orgs

Phase 1
46
Phase 2
125
Phase 3
104
Phase 4
106

Earliest trial started Aug 1, 1987 (NCT00065949)

Timeline

1980s

  1. Oct 6, 1981

    Earliest FDA Approval

  2. Oct 6, 1981

    Baxalta — Marketing Organization

  3. Oct 6, 1981

    Baxter — NDA Secondary Org

  4. Sep 8, 1986

    Fresenius — NDA Secondary Org

  5. Jan 1, 1987

    Earliest Phase 3 Sponsor(trial)

1990s

  1. Jun 24, 1994

    Hospira — NDA Secondary Org

  2. Sep 27, 1996

    Lukare Medical — Marketing Organization

  3. Sep 27, 1996

    Lukare Medical — NDA Secondary Org

2000s

  1. Jan 1, 2004

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2008

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Aug 5, 2010

    Braintree Laboratories — Marketing Organization

  2. Aug 5, 2010

    Braintree Laboratories — NDA Secondary Org

  3. Dec 18, 2014

    Exela Pharma Sciences, LLC. — Marketing Organization

  4. May 14, 2015

    Hospira — Marketing Organization

  5. May 14, 2015

    Pfizer — Marketing Organization

  6. Mar 2, 2016

    Hq Speciality Pharma — Marketing Organization

  7. Mar 7, 2016

    Fresenius — Marketing Organization

  8. Aug 18, 2016

    Paddock Laboratories — Marketing Organization

  9. Aug 18, 2016

    Perrigo — Marketing Organization

  10. Nov 14, 2016

    Esteve Labs — Marketing Organization

  11. Dec 27, 2016

    Gator Pharmaceuticals — Marketing Organization

  12. Dec 27, 2016

    Gator Pharmaceuticals — NDA Secondary Org

  13. Feb 23, 2017

    Novel Anti-Infective Technologies, LLC — Marketing Organization

  14. Sep 10, 2018

    Mylan — Marketing Organization

  15. Oct 26, 2018

    Taro Pharmaceuticals — Marketing Organization

  16. Oct 26, 2018

    Sun Pharmaceuticals — Marketing Organization

2020s

  1. Jun 1, 2020

    Takeda — Marketing Organization

  2. Jul 10, 2020

    Gland Pharma Ltd — Marketing Organization

  3. Jul 10, 2020

    Fosun — Marketing Organization

  4. Oct 27, 2020

    B. Braun — Marketing Organization

  5. Jun 15, 2021

    Annora Pharma — Marketing Organization

  6. Nov 8, 2021

    Milla Pharms — Marketing Organization

  7. Nov 8, 2021

    Pts Consulting — Marketing Organization

  8. Feb 15, 2023

    Amneal Pharmaceuticals — Marketing Organization

  9. Nov 22, 2023

    Strides Pharma Science — Marketing Organization

  10. Dec 29, 2023

    Alkem Labs Ltd — Marketing Organization

  11. Jun 24, 2024

    Bionpharma Inc — Marketing Organization

  12. Jul 15, 2024

    Lannett Company, Inc. — Marketing Organization

Indications

Studied for

Mechanism of action

  • Unspecified targetOTHER

    Unknown

Combination products

Approval history

  • approvedOct 6, 1981

Chemistry & pharmacology

Loading structure…

SMILES

O.O.O.O.O.O.O.O=S(=O)([O-])[O-].[Mg+2]
Mol. weight
246.47 g/mol
Chirality
Achiral Molecule
Inorganic
Yes
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Sources

Also known as

  • epsom salt
  • epsom salt
  • magesium sulphate
  • magnesium(ii) sulfate
  • magnesium(ii) sulfate
  • magnesiumsulfat
  • magnesiumsulfat
  • magnesium sulfate
  • magnesium sulfate
  • magnesium sulfate
  • magnesium sulfate
  • magnesium sulfate
  • magnesium sulfate
  • magnesium sulfate
  • magnesium sulfate
  • magnesium sulfate
  • magnesium sulfate
  • magnesium sulfate (1:1)
  • magnesium sulfate (1:1)
  • magnesium sulfate anhydrous
  • magnesium sulfate anhydrous
  • magnesium sulfate anhydrous
  • magnesium sulfate anhydrous
  • magnesium sulfate heptahydrate
  • magnesium sulfate mixture with potassium sulfate and sodium sulfate
  • magnesium sulfate, unspecified
  • magnesium sulphate
  • magnesium sulphate
  • magnesium sulphate
  • magnesium sulphate
  • magnesium sulphate
  • mag sulf
  • mgso4
  • mgso4
  • original andrews salts
  • sulfuric acid magnesium salt

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07298564N/AJan 30, 2026Azad University
NCT07220902Phase 3Jan 1, 2026Nebraska Methodist Health System
NCT07309640N/AJan 1, 2026Univerisiti Sains Malaysia
NCT07126795Phase 1Jan 1, 2026Hennepin Healthcare
NCT06904287Phase 3Dec 31, 2025Wake Forest University
NCT07149649Phase 2/Phase 3 (Phase 3)Dec 31, 2025Swiss Cancer Institute
NCT07252505Early Phase 1 (Phase 1)Nov 30, 2025Assiut University
NCT07173855Phase 4Nov 25, 2025Scarborough General Hospital
NCT07213037Phase 3Nov 1, 2025Assiut University
NCT07139847N/AOct 30, 2025Ondokuz Mayıs University
NCT07199595N/AOct 20, 2025Assiut University
NCT07258628N/AOct 10, 2025Ankara Yildirim Beyazıt University
NCT06959251N/AOct 2, 2025Instituto Nacional de Enfermedades Respiratorias
NCT06785272Phase 3Sep 30, 2025McMaster University, St. Justine's Hospital, University of Alberta, University of Calgary, University of Toronto
NCT07181564N/ASep 11, 2025University of Patras
NCT07105618N/AAug 10, 2025Zagazig University
NCT07082894N/AJul 25, 2025Tanta University
NCT06975072Phase 4Jul 1, 2025University of California, San Francisco
NCT07248540N/AJul 1, 2025Gaziosmanpasa University
NCT06956521Phase 1Jun 30, 2025Baylor University
Showing 20 of 435 trials
Page 1 / 22

Organizations

Research & Development (296)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Assiut UniversityAcademic/Hospital525252015
Cairo UniversityAcademic/Hospital373652012
Seoul National UniversityAcademic/Hospital191822010
Ain Shams UniversityAcademic/Hospital171652013
Mansoura UniversityAcademic/Hospital8732016
University of Sao PauloAcademic/Hospital8842004
Queen's University, BelfastAcademic/Hospital6622006
University of MonastirAcademic/Hospital6622005
Zagazig UniversityAcademic/Hospital6632018
Beni Suef UniversityAcademic/Hospital5542019
Braintree LaboratoriesFor profit5522007
National Cancer Institute, EgyptGovernment5532015
National Cancer Institute (NCI)Government5222006
Hamad Medical CorporationFor profit4432012
Mayo ClinicAcademic/Hospital4222006
Tanta UniversityAcademic/Hospital4422023
University Clermont AuvergneAcademic/Hospital4442004
University of British ColumbiaAcademic/Hospital4412007
University of GenevaAcademic/Hospital4422006
University of TorontoAcademic/Hospital4422006
296 organizations
Page 1 / 15

Marketing (38)

OrganizationOrg typeRelationshipDate
Alkem Labs LtdFor profitMKTGDec 29, 2023
Amneal PharmaceuticalsFor profitMKTGFeb 15, 2023
Annora PharmaFor profitMKTGJun 15, 2021
B. BraunFor profitMKTGOct 27, 2020
BaxaltaFor profitSYNJun 1, 2020
BaxaltaFor profitNDA
BaxaltaFor profitMKTGOct 6, 1981
BaxterFor profitNDA2Oct 6, 1981
Bionpharma IncFor profitMKTGJun 24, 2024
Braintree LaboratoriesFor profitMKTGAug 5, 2010
Braintree LaboratoriesFor profitNDA2Aug 5, 2010
Esteve LabsFor profitMKTGNov 14, 2016
Exela Pharma Sciences, LLC.For profitMKTGDec 18, 2014
Exela Pharma Sciences, LLC.For profitSYNDec 18, 2014
FosunFor profitMKTGJul 10, 2020
FreseniusFor profitNDA2Sep 8, 1986
FreseniusFor profitMKTGMar 7, 2016
Gator PharmaceuticalsFor profitMKTGDec 27, 2016
Gator PharmaceuticalsFor profitNDA2Dec 27, 2016
Gland Pharma LtdFor profitMKTGJul 10, 2020
HospiraFor profitNDA2Jun 24, 1994
HospiraFor profitMKTGMay 14, 2015
Hq Speciality PharmaFor profitMKTGMar 2, 2016
Lannett Company, Inc.For profitMKTGJul 15, 2024
Lukare MedicalFor profitMKTGSep 27, 1996
Lukare MedicalFor profitNDA2Sep 27, 1996
Milla PharmsFor profitMKTGNov 8, 2021
MylanFor profitMKTGSep 10, 2018
Novel Anti-Infective Technologies, LLCFor profitMKTGFeb 23, 2017
Paddock LaboratoriesFor profitMKTGAug 18, 2016
PerrigoFor profitMKTGAug 18, 2016
PfizerFor profitMKTGMay 14, 2015
Pts ConsultingFor profitMKTGNov 8, 2021
Strides Pharma ScienceFor profitMKTGNov 22, 2023
Sun PharmaceuticalsFor profitMKTGOct 26, 2018
TakedaFor profitMKTGJun 1, 2020
Taro PharmaceuticalsFor profitMKTGOct 26, 2018
Taro PharmaceuticalsFor profitSYNMar 19, 2024