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magnesium

Small moleculeapproved

Approved

Dec 7, 1953

Magnesium aspartate dihydrate is one of the most absorbable forms of magnesium. It is used as a source of magnesium in dietary foods for special medical purposes, was not of safety concern at the established levels of usage and that there would be no safety concern from aspartate at the established usage levels. Magnesium is often suggested to be taken with calcium supplements. — NCATS

Clinical trial activity

75 trials · 82 clinical orgs · 41 marketing orgs

Phase 1
10
Phase 2
22
Phase 3
12
Phase 4
16

Earliest trial started Nov 1, 2005 (NCT00242164)

Timeline

1950s

  1. Dec 7, 1953

    Evidence of US Marketing

  2. Dec 7, 1953

    Earliest FDA Approval

  3. Dec 7, 1953

    DAVA Pharmaceuticals — Marketing Organization

  4. Dec 7, 1953

    Strides Pharma Science — Marketing Organization

  5. Aug 10, 1959

    Hospira — NDA Secondary Org

1970s

  1. Sep 24, 1971

    B. Braun — First NDA Organization

  2. Sep 24, 1971

    B. Braun — NDA Organization

  3. Aug 13, 1975

    ICU Medical Inc — NDA Secondary Org

  4. Mar 24, 1976

    Baxter — NDA Secondary Org

  5. Feb 1, 1979

    Baxalta — NDA Secondary Org

  6. Sep 5, 1979

    Bristol-Myers — Marketing Organization

1980s

  1. Aug 5, 1980

    B. Braun — NDA Secondary Org

  2. Sep 3, 1980

    Fresenius — NDA Secondary Org

  3. Oct 28, 1981

    Nestle — NDA Secondary Org

  4. Feb 14, 1985

    Bristol-Myers Squibb — Marketing Organization

  5. May 9, 1986

    Norbrook — Marketing Organization

  6. Jun 13, 1986

    Abraxis — Marketing Organization

  7. Sep 16, 1986

    West-Ward Pharmaceutical — Marketing Organization

  8. Dec 16, 1986

    Abbott — NDA Secondary Org

  9. Jul 8, 1988

    Pharmachemie Bv — Marketing Organization

1990s

  1. Oct 15, 1990

    Barr Laboratories — Marketing Organization

  2. Aug 23, 1991

    Pharmacia & Upjohn — Marketing Organization

  3. Nov 27, 1991

    Akorn, Inc. — NDA Secondary Org

  4. Nov 27, 1991

    Epic Pharma Llc — NDA Secondary Org

  5. Aug 1, 1994

    Hikma — Marketing Organization

  6. Feb 26, 1999

    Fresenius — Marketing Organization

  7. Jun 17, 1999

    Duramed Research — Marketing Organization

2000s

  1. Apr 21, 2000

    Baxter — Marketing Organization

  2. Jan 1, 2005

    Earliest Phase 2 Sponsor(trial)

  3. Jul 26, 2006

    Henry Schein, Inc — NDA Secondary Org

  4. Jul 26, 2006

    Watson Pharmaceuticals — NDA Secondary Org

  5. Sep 27, 2006

    Akorn, Inc. — Marketing Organization

  6. Apr 30, 2007

    Accord Research — Marketing Organization

  7. Jul 24, 2008

    Alcon — NDA Secondary Org

  8. Mar 31, 2009

    Sandoz — Marketing Organization

2010s

  1. Feb 3, 2010

    B. Braun — Marketing Organization

  2. Mar 29, 2012

    Rising Pharmaceuticals — Marketing Organization

  3. Mar 29, 2012

    Mylan — Marketing Organization

  4. Mar 29, 2012

    EXTROVIS — Marketing Organization

  5. Jan 1, 2013

    Earliest Phase 1 Sponsor(trial)

  6. Jan 1, 2014

    Earliest Phase 3 Sponsor(trial)

  7. May 21, 2015

    Sun Pharmaceuticals — Marketing Organization

  8. Jan 13, 2017

    Zydus Discovery DMCC — Marketing Organization

  9. Apr 25, 2017

    Silvergate Pharmaceuticals — Marketing Organization

  10. Apr 25, 2017

    Azurity — Marketing Organization

  11. Dec 22, 2017

    Amneal Pharmaceuticals — Marketing Organization

  12. Aug 9, 2018

    Sagent Pharmaceuticals, Inc. — Marketing Organization

2020s

  1. Jan 30, 2020

    Eugia Pharma — Marketing Organization

  2. Apr 23, 2021

    Lotus Pharmaceutical — Marketing Organization

  3. Aug 7, 2023

    Daito Pharmaceuticals — Marketing Organization

  4. May 16, 2024

    Elite Laboratories, Inc — Marketing Organization

  5. Jun 3, 2024

    Alembic — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

  • magnesiumSupplementation

    magnesium supplementation

  • ElectrolyteSupplementation

    Electrolyte supplementation

  • Unspecified targetUnclear

    unclear

Combination products

Approval history

  • approvedPriority reviewDec 7, 1953
  • approvedPriority reviewDec 7, 1953

Chemistry & pharmacology

Loading structure…

SMILES

CC(=O)[O-].CC(=O)[O-].O.O.O.O.[Mg+2]
Mol. weight
214.45 g/mol
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Discontinued

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • acetic acid, magnesium salt, tetrahydrate
  • acetic acid, magnesium salt, tetrahydrate
  • anhydrous magnesium chloride
  • anhydrous magnesium chloride
  • cromosan
  • dialysate magnesium
  • e511
  • e511
  • magnesia calcinada
  • magnesium acetate
  • magnesium acetate
  • magnesium acetate
  • magnesium acetate tetrahydrate
  • magnesium acetate tetrahydrate
  • magnesium acetate tetrahydrate
  • magnesium acetate tetrahydrate
  • magnesium chloride
  • magnesium chloride
  • magnesium chloride
  • magnesium chloride
  • magnesium chloride
  • magnesium chloride
  • magnesium chloride
  • magnesium chloride
  • magnesium chloride anhydrous
  • magnesium chloride anhydrous
  • magnesium chloride hydrate
  • magnesium chloride hydrate
  • magnesium diacetate
  • magnesium diacetate tetrahydrate
  • magnesium diacetate tetrahydrate
  • magnesium salt
  • magnogene
  • magnogene
  • magnogene

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07147972Phase 3Aug 20, 2025Fayoum University
NCT06386211Phase 1Jul 3, 2024Sanofi
NCT05837104Phase 2Dec 13, 2023Mclean Hospital
NCT05586009Phase 2Oct 31, 2022Tanta University
NCT05558969N/ASep 28, 2022Eskisehir Osmangazi University
NCT05449171N/ASep 1, 2022Lo.Li. Pharma, Ltd.
NCT05253209Phase 3Jun 29, 2022Asklepion, Indiana University
NCT05598307N/AJun 1, 2022Aretaieion University, National Kapodistrian University of Athens
NCT05339308N/AMay 1, 2022Masaryk University, University of Ljubljana
NCT05294367Early Phase 1 (Phase 1)Apr 15, 2022Mayo Clinic, National Cancer Institute (NCI)
NCT05642182Phase 1Mar 31, 2022SFA Therapeutics
NCT05271838N/AFeb 8, 2022Aarhus University, University of Copenhagen
NCT05630339N/AJan 30, 2022Consejo de Ciencia y Tecnología del Estado de Durango, Government of Mexico, Instituto Mexicano del Seguro Social
NCT05523791N/AJan 1, 2022Ospedale generale di Zona Moriggia-Pelascini
NCT05282693N/ADec 17, 2021Colorado State University
NCT04651205N/AOct 31, 2021University of Glasgow
NCT05067270Phase 1Oct 22, 2021Eli Lilly
NCT05091138N/AOct 12, 2021Wayne State University
NCT05032781Phase 1Jun 1, 2021Northwell Health
NCT04747171N/AApr 30, 2021Benha University
Showing 20 of 75 trials
Page 1 / 4

Organizations

Research & Development (82)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
B. BraunFor profit4412010
Yuria-PharmFor profit4412016
AlconFor profit3222008
FreseniusFor profit3012011
Aarhus UniversityAcademic/Hospital2212011
Allegro Ophthalmics, LLCFor profit2212014
Bangladesh Medical UniversityAcademic/Hospital2222019
Duke UniversityAcademic/Hospital2112014
European Society of AnaesthesiologyAcademic/Hospital2012017
Instituto Mexicano del Seguro SocialGovernment2122006
Maastricht UniversityAcademic/Hospital2012017
National Cancer Institute, EgyptGovernment2212017
Thomas Jefferson UniversityAcademic/Hospital2212009
University Clermont AuvergneAcademic/Hospital2222006
University of CopenhagenAcademic/Hospital2122016
University of GuadalajaraAcademic/Hospital2212016
University of Sao PauloAcademic/Hospital2212008
Wayne State UniversityAcademic/Hospital2212020
Aretaieion UniversityAcademic/Hospital1112022
Aristotle University of ThessalonikiAcademic/Hospital1112020
82 organizations
Page 1 / 5

Marketing (57)

OrganizationOrg typeRelationshipDate
AbbottFor profitNDA2Dec 16, 1986
AbraxisFor profitMKTGJun 13, 1986
Accord ResearchFor profitMKTGApr 30, 2007
Akorn, Inc.For profitNDA2Nov 27, 1991
Akorn, Inc.For profitMKTGSep 27, 2006
AlconFor profitNDA2Jul 24, 2008
AlconFor profitSYNOct 28, 1981
AlembicFor profitMKTGJun 3, 2024
Amneal PharmaceuticalsFor profitMKTGDec 22, 2017
AzurityFor profitMKTGApr 25, 2017
B. BraunFor profitNDA2Aug 5, 1980
B. BraunFor profitMKTGFeb 3, 2010
B. BraunFor profitNDASep 24, 1971
Barr LaboratoriesFor profitMKTGOct 15, 1990
BaxaltaFor profitNDA2Oct 25, 2006
BaxaltaFor profitSYNMar 24, 1976
BaxaltaFor profitNDA2Feb 1, 1979
BaxterFor profitNDA2Mar 24, 1976
BaxterFor profitMKTGApr 21, 2000
Bristol-MyersFor profitMKTGSep 5, 1979
Bristol-Myers SquibbFor profitSYNApr 14, 1989
Bristol-Myers SquibbFor profitMKTGFeb 14, 1985
DAVA PharmaceuticalsFor profitMKTGDec 7, 1953
Daito PharmaceuticalsFor profitMKTGAug 7, 2023
Duramed ResearchFor profitMKTGJun 17, 1999
EXTROVISFor profitMKTGMar 29, 2012
Elite Laboratories, IncFor profitMKTGMay 16, 2024
Epic Pharma LlcFor profitNDA2Nov 27, 1991
Eugia PharmaFor profitSYNMar 29, 2012
Eugia PharmaFor profitMKTGJan 30, 2020
FreseniusFor profitSYNJun 13, 1994
FreseniusFor profitMKTGFeb 26, 1999
FreseniusFor profitNDA2Sep 3, 1980
Henry Schein, IncFor profitNDA2Jul 26, 2006
HikmaFor profitMKTGAug 1, 1994
HikmaFor profitSYNSep 16, 1986
HospiraFor profitSYNJan 3, 1978
HospiraFor profitNDA2Aug 10, 1959
ICU Medical IncFor profitNDA2Aug 13, 1975
Lotus PharmaceuticalFor profitMKTGApr 23, 2021
MylanFor profitMKTGMar 29, 2012
MylanFor profitSYNMay 15, 1992
NestleFor profitNDA2Oct 28, 1981
NorbrookFor profitMKTGMay 9, 1986
Pharmachemie BvFor profitMKTGJul 8, 1988
Pharmachemie BvFor profitSYNJan 8, 2010
Pharmacia & UpjohnFor profitMKTGAug 23, 1991
Rising PharmaceuticalsFor profitMKTGMar 29, 2012
Sagent Pharmaceuticals, Inc.For profitMKTGAug 9, 2018
SandozFor profitMKTGMar 31, 2009
SandozFor profitSYNMar 31, 2009
Silvergate PharmaceuticalsFor profitMKTGApr 25, 2017
Strides Pharma ScienceFor profitMKTGDec 7, 1953
Sun PharmaceuticalsFor profitMKTGMay 21, 2015
Watson PharmaceuticalsFor profitNDA2Jul 26, 2006
West-Ward PharmaceuticalFor profitMKTGSep 16, 1986
Zydus Discovery DMCCFor profitMKTGJan 13, 2017