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sodium benzoate

Trade name: AMMONUL

Small moleculeapprovedOrphan Drug FDA

Approved

Dec 23, 1987

Sodium benzoate also known as benzoate of soda is the sodium salt of benzoic acid, widely used as a food preservative and a pickling agent. It appears as a white crystalline chemical with the formula C6H5COONa. — Wikipedia

Clinical trial activity

25 trials · 21 clinical orgs · 6 marketing orgs

Phase 1
1
Phase 2
16
Phase 3
3
Phase 4
0

Earliest trial started Jan 1, 1985 (NCT00004767)

Timeline

1980s

  1. Jan 1, 1985

    Earliest Phase 2 Sponsor(trial)

  2. Jan 21, 1986

    Orphan Drug Designation

  3. Dec 23, 1987

    B. Braun — Earliest FDA Approval

  4. Dec 23, 1987

    B. Braun — NDA Secondary Org

  5. Dec 23, 1987

    B. Braun — NDA Organization

2000s

  1. Jan 1, 2005

    Earliest Phase 1 Sponsor(trial)

  2. Feb 17, 2005

    Medicis — NDA Secondary Org

  3. Feb 17, 2005

    Bausch Health Companies — NDA Secondary Org

2010s

  1. Feb 24, 2016

    Ailex Pharmaceuticals — Marketing Organization

  2. Aug 4, 2016

    Navinta — Marketing Organization

  3. May 8, 2017

    Maia Pharms Inc — Marketing Organization

2020s

  1. Jun 10, 2021

    Maia Pharms Inc — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

  • Unspecified targetOTHER

    Unknown

Combination products

Approval history

  • approvedPriority reviewDec 23, 1987

Chemistry & pharmacology

Loading structure…

SMILES

O=C([O-])c1ccccc1.[Na+]
Mol. weight
144.1 g/mol
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Sources

Also known as

  • amzoate
  • daoi-b
  • e211
  • e211
  • mthwsh
  • naben
  • sodium benzoate
  • sodium benzoate
  • sodium benzoate
  • sodium benzoate
  • sodium benzoate
  • sodium benzoate
  • sodium benzoate

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06467539Phase 2Jun 19, 2024Chang Gung University
NCT06340789Phase 2Apr 10, 2024National Cheng Kung University
NCT05181189Phase 2Aug 1, 2023Chang Gung University
NCT05764538Phase 2Feb 27, 2023Chang Gung University
NCT05582161Phase 2Oct 3, 2022Chang Gung University
NCT05006781Phase 2Aug 20, 2021Chang Gung University
NCT04737096Phase 2Jan 1, 2020Chang Gung University
NCT04736355Phase 2Jan 1, 2020Chang Gung University
NCT03510741Phase 2Jun 1, 2018Pakistan Institute of Living and Learning, Ziauddin University
NCT03190785N/AJul 1, 2017East Carolina University
NCT04022941N/AApr 1, 2017Institute of Liver and Biliary Sciences, India
NCT03094429Phase 2/Phase 3 (Phase 3)Mar 29, 2017Amarex Clinical Research, SyneuRx International (Taiwan) Corp
NCT02261519Phase 2/Phase 3 (Phase 3)Mar 29, 2017SyneuRx International (Taiwan) Corp
NCT03752463Phase 2May 22, 2015Chang Gung University, Government of Taiwan
NCT02111200N/ASep 1, 2014Baylor University
NCT01908192Phase 2/Phase 3 (Phase 3)Jun 1, 2014Hugo W. Moser Research Institute at Kennedy Krieger, Inc., SyneuRx International (Taiwan) Corp
NCT02103673Phase 2Feb 1, 2014Chang Gung University, China Medical University
NCT02026947Phase 2Feb 1, 2014Karolinska Institute, Niuvanniemi Hospital
NCT02239003Phase 2Jan 1, 2012Chang Gung University, China Medical University
NCT01600469Phase 2Jan 1, 2012Chang Gung University, China Medical University
Showing 20 of 25 trials
Page 1 / 2

Organizations

Research & Development (21)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Chang Gung UniversityAcademic/Hospital111112012
China Medical UniversityAcademic/Hospital3012012
SyneuRx International (Taiwan) CorpFor profit3312014
Horizon PharmaFor profit2222005
Amarex Clinical ResearchFor profit1012017
Baylor UniversityAcademic/Hospital1112014
East Carolina UniversityAcademic/Hospital1112017
Government of TaiwanGovernment1012015
Hillel Yaffe Medical CenterAcademic/Hospital1112009
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.Academic/Hospital1012014
Institute of Liver and Biliary Sciences, IndiaAcademic/Hospital1112017
Johns Hopkins UniversityAcademic/Hospital1011985
Karolinska InstituteAcademic/Hospital1012014
Memorial Hermann Health SystemAcademic/Hospital1012010
National Center for Research Resources (NCRR)Government1111985
National Cheng Kung UniversityAcademic/Hospital1112024
Niuvanniemi HospitalAcademic/Hospital1112014
Pakistan Institute of Living and LearningAcademic/Hospital1112018
UcyclydFor profit1012005
University of Texas at HoustonAcademic/Hospital1112010
21 organizations
Page 1 / 2

Marketing (8)

OrganizationOrg typeRelationshipDate
Ailex PharmaceuticalsFor profitMKTGFeb 24, 2016
B. BraunFor profitNDA2Dec 23, 1987
B. BraunFor profitNDADec 23, 1987
Bausch Health CompaniesFor profitNDA2Feb 17, 2005
Maia Pharms IncFor profitMKTGMay 8, 2017
Maia Pharms IncFor profitNDA2Jun 10, 2021
MedicisFor profitNDA2Feb 17, 2005
NavintaFor profitMKTGAug 4, 2016