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sodium sulfate

Small moleculeapproved

Approved

Jul 13, 1984

SULFATE (as sodium sulfate, potassium sulfate, and magnesium sulfate) is a component of SUPREP Bowel Prep Kit. It is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults. Sulfate salts provide sulfate anions, which are poorly absorbed. The osmotic effect of unabsorbed sulfate anions and the associated cations causes water to be retained within the gastrointestinal tract. SUPREP Bowel Prep Kit, when ingested with a large volume of water, produces copious watery diarrhea. — NCATS

Clinical trial activity

27 trials · 34 clinical orgs · 19 marketing orgs

Phase 1
2
Phase 2
14
Phase 3
12
Phase 4
8

Earliest trial started Jul 1, 2007 (NCT00503607)

Timeline

1980s

  1. Jul 13, 1984

    Braintree Laboratories — Earliest FDA Approval

  2. Jul 13, 1984

    Braintree Laboratories — NDA Secondary Org

  3. Jul 13, 1984

    Braintree Laboratories — NDA Organization

  4. Oct 26, 1984

    Mylan — NDA Secondary Org

  5. Apr 30, 1986

    Hospira — NDA Secondary Org

  6. Apr 20, 1988

    Dynapharm — Marketing Organization

  7. Dec 23, 1988

    Goldline — Marketing Organization

1990s

  1. Jan 28, 1992

    Vintage — Marketing Organization

2000s

  1. Jan 1, 2007

    Braintree Laboratories — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2007

    Braintree Laboratories — Earliest Phase 3 Sponsor(trial)

  3. Jun 1, 2009

    Novel Anti-Infective Technologies, LLC — Marketing Organization

2010s

  1. Jan 28, 2010

    Mylan — Marketing Organization

  2. Feb 25, 2010

    Paddock Laboratories — Marketing Organization

  3. Jan 1, 2014

    Braintree Laboratories — Earliest Phase 2 Sponsor(trial)

  4. Aug 18, 2016

    Perrigo — Marketing Organization

  5. Nov 14, 2016

    Esteve Labs — Marketing Organization

  6. Dec 27, 2016

    Gator Pharmaceuticals — NDA Secondary Org

  7. May 4, 2018

    Salix — NDA Secondary Org

  8. May 4, 2018

    Bausch Health Companies — NDA Secondary Org

  9. Oct 26, 2018

    Taro Pharmaceuticals — Marketing Organization

  10. Oct 26, 2018

    Sun Pharmaceuticals — Marketing Organization

  11. Dec 21, 2018

    Strides Pharma Science — Marketing Organization

2020s

  1. Jun 15, 2021

    Annora Pharma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

  • Unspecified targetOTHER

    Laxative

    Induces catharsis by the osmotic effects of the unabsorbed sulfate salts and polyethylene glycol (PEG) in the GI tract.

  • Unspecified targetSupplementation

    supplementation

Combination products

Approval history

  • approvedJul 13, 1984

Chemistry & pharmacology

Loading structure…

SMILES

O.O.O.O.O.O.O.O.O.O.O=S(=O)([O-])[O-].[Na+].[Na+]
Mol. weight
322.19 g/mol
Chirality
Achiral Molecule
Inorganic
Yes
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • anhydrous sodium sulfate
  • anhydrous sodium sulfate
  • bli800
  • disodium sulfate
  • disodium sulfate
  • e514
  • e514
  • glauber's salt
  • glaubers salt
  • glaubers salt
  • golytely
  • golytely
  • magnesium sulfate mixture with potassium sulfate and sodium sulfate
  • mangxiao
  • mirabilitum
  • natrii sulphas
  • puxiao
  • sodium bisulfate
  • sodium bisulfate, monohydrate
  • sodium hydrosulfate
  • sodium sulfate
  • sodium sulfate
  • sodium sulfate
  • sodium sulfate
  • sodium sulfate
  • sodium sulfate
  • sodium sulfate
  • sodium sulfate
  • sodium sulfate
  • sodium sulfate, 35s-labeled cpd
  • sodium sulfate anhydrous
  • sodium sulfate anhydrous
  • sodium sulfate anhydrous
  • sodium sulfate anhydrous
  • sodium sulfate, anhydrous
  • sodium sulfate, anhydrous
  • sodium sulfate, decahydrate
  • sodium sulfate, dried
  • sodium sulfate, dried
  • sodium sulfates
  • sodium sulphate
  • sodium sulphate
  • sodium sulphate anhydrous
  • sodium sulphate anhydrous
  • sodium sulphate anhydrous
  • sodium sulphate, anhydrous
  • sodium sulphate, anhydrous
  • sulfuric acid disodium salt
  • sulfuric acid disodium salt, anhydrous
  • sulfuric acid disodium salt, anhydrous
  • sulfuric acid, monosodium salt
  • thenardite

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06949176N/ADec 1, 2023University of Athens
NCT06051955N/AOct 1, 2023Pendopharm, Queen's University, Belfast
NCT05570669Phase 4May 25, 2021Azienda Ospedaliera Specializzata in Gastroenterologia IRCCS Saverio de Bellis, Societa Italiana di Endoscopia Digestiva, University of Bologna, University of Naples Frederico II, University of Roma La Sapienza
NCT04474002Phase 4Aug 31, 2020The University of Hong Kong
NCT04214301Phase 4Sep 24, 2019Braintree Laboratories
NCT04758156Phase 4Aug 1, 2019Seoul National University
NCT03992365Phase 3Jun 10, 2019China Medical University, Universal Integrated Corp.
NCT05465889Phase 3May 15, 2019Changhai Hospital, Hebei Medical University, Henan Provincal People's Hospital, Jiao Tong University, Jilin University, Nanchang University, Peking University, Shandong University, Xiamen University
NCT03562884Phase 3Jul 2, 2018Ipsen
NCT03437265Phase 1Apr 4, 2018Norgine, Quotient
NCT03520361Phase 4Nov 2, 2017KangWon National University
NCT03198221Phase 4Jul 1, 2017Ferring, University of Rochester
NCT02819323Phase 3Jun 1, 2016Braintree Laboratories
NCT03106922Phase 3Apr 1, 2016Alfa Wassermann, University of Roma La Sapienza
NCT02523911N/AMar 1, 2016Iowa Digestive Disease Center, Mercy Medical Center, Des Moines, Iowa, University of Florida
NCT02481219N/AMay 1, 2015Medtronic
NCT02321462Phase 3Mar 1, 2015Ipsen
NCT02189850Phase 2Jun 1, 2014Braintree Laboratories
NCT01786629Phase 4Dec 1, 2012Braintree Laboratories
NCT01719653Phase 4Oct 1, 2012Gastroenterology Services, Ltd.
Showing 20 of 27 trials
Page 1 / 2

Organizations

Research & Development (34)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Braintree LaboratoriesFor profit111132007
IpsenFor profit2212015
University of Roma La SapienzaAcademic/Hospital2022016
Alfa WassermannFor profit1112016
Azienda Ospedaliera Specializzata in Gastroenterologia IRCCS Saverio de BellisAcademic/Hospital1012021
Changhai HospitalAcademic/Hospital1112019
China Medical UniversityAcademic/Hospital1012019
FerringFor profit1012017
Gastroenterology Services, Ltd.Academic/Hospital1112012
Hebei Medical UniversityAcademic/Hospital1012019
Henan Provincal People's HospitalAcademic/Hospital1012019
Iowa Digestive Disease CenterAcademic/Hospital1012016
Jiao Tong UniversityAcademic/Hospital1012019
Jilin UniversityAcademic/Hospital1012019
KangWon National UniversityAcademic/Hospital1112017
MedtronicFor profit1112015
Mercy Medical Center, Des Moines, IowaAcademic/Hospital1112016
Nanchang UniversityAcademic/Hospital1012019
NorgineFor profit1112018
Peking UniversityAcademic/Hospital1012019
34 organizations
Page 1 / 2

Marketing (23)

OrganizationOrg typeRelationshipDate
Annora PharmaFor profitMKTGJun 15, 2021
Bausch Health CompaniesFor profitNDA2May 4, 2018
Braintree LaboratoriesFor profitNDA2Jul 13, 1984
Braintree LaboratoriesFor profitSYNAug 5, 2010
Braintree LaboratoriesFor profitNDAJul 13, 1984
DynapharmFor profitMKTGApr 20, 1988
E Z EMFor profitMKTG—
Esteve LabsFor profitMKTGNov 14, 2016
Gator PharmaceuticalsFor profitNDA2Dec 27, 2016
GoldlineFor profitMKTGDec 23, 1988
HospiraFor profitNDA2Apr 30, 1986
MylanFor profitMKTGJan 28, 2010
MylanFor profitNDA2Oct 26, 1984
Novel Anti-Infective Technologies, LLCFor profitMKTGJun 1, 2009
Paddock LaboratoriesFor profitMKTGFeb 25, 2010
PerrigoFor profitMKTGAug 18, 2016
SalixFor profitNDA2May 4, 2018
SalixFor profitSYNAug 2, 2006
SandozFor profitMKTG—
Strides Pharma ScienceFor profitMKTGDec 21, 2018
Sun PharmaceuticalsFor profitMKTGOct 26, 2018
Taro PharmaceuticalsFor profitMKTGOct 26, 2018
VintageFor profitMKTGJan 28, 1992