sodium succinate

Small moleculeapproved

Approved

Nov 16, 1971

Succinic acid is a dicarboxylic acid, which has multiple biological roles as a metabolic intermediate being converted into fumarate by the enzyme succinate dehydrogenase in complex 2 of the electron transport chain which is involved in making ATP, and as a signaling molecule reflecting the cellular metabolic state. Succinate is generated in mitochondria via the tricarboxylic acid cycle (TCA), an energy-yielding process shared by all organisms. Succinate can exit the mitochondrial matrix and function in the cytoplasm as well as the extracellular space, changing gene expression patterns, modulating epigenetic landscape or demonstrating hormone-like signaling. Dysregulation of succinate synthesis, and therefore ATP synthesis, happens in some genetic mitochondrial diseases, such as Leigh's disease, and Mela's disease and degradation can lead to pathological conditions, such as malignant transformation, inflammation and tissue injury. Succinic acid is a precursor to some polyesters and a component of some alkyd resins. Succinic acid also serves as the bases of certain biodegradable polymers, which are of interest in tissue engineering applications. As a food additive and dietary supplement, succinic acid is generally recognized as safe by the U.S. Food and Drug Administration. Succinic acid is used primarily as an acidity regulator in the food and beverage industry. It is also available as a flavoring agent, contributing a somewhat sour and astringent component to umami taste.[11] As an excipient in pharmaceutical products, it is also used to control acidity or as a counter ion. Drugs involving succinate include metoprolol succinate, sumatriptan succinate, Doxylamine succinate or solifenacin succinate. — NCATS

Clinical trial activity

10 trials · 29 clinical orgs · 1 marketing orgs

Phase 1
0
Phase 2
9
Phase 3
9
Phase 4
0

Earliest trial started Jun 1, 2016 (NCT02930161)

Timeline

1970s

  1. Nov 16, 1971

    Earliest FDA Approval

  2. Nov 16, 1971

    Elkins Sinn — Marketing Organization

2010s

  1. Jan 1, 2016

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2017

    Earliest Phase 3 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedNov 16, 1971

Chemistry & pharmacology

Loading structure…

SMILES

OC(=O)CCC(O)=O
Mol. weight
118.088 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Discontinued

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • butanedioic acid
  • butanedioic acid
  • butanedioic acid
  • butanedioic acid
  • butanedioic acid
  • runihol
  • sodium succinate
  • sodium succinate
  • sodium succinate
  • succinic acid
  • succinic acid
  • succinic acid

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06183242Phase 2/Phase 3 (Phase 3)May 27, 2023Polysan, Ltd.
NCT05935787Phase 3Mar 23, 2023Polysan, Ltd.
NCT04631484Phase 3Oct 8, 2020Polysan, Ltd.
NCT04649203Phase 3Jun 29, 2020Polysan, Ltd.
NCT04134403Phase 3Dec 1, 2019Baqiyatallah Medical Sciences University, East Carolina University, Hamadan University of Medical Science, University of Tehran
NCT03401398Phase 3Jan 2, 2019Canadian Critical Care Trials Group, Canadian Institutes of Health Research (CIHR), Harvard University, National Institutes of Health (NIH), University of Cincinnati, University of Ottawa, University of Washington
NCT03849664Phase 3Jun 2, 2017Polysan, Ltd., St. Petersburg Research Institute of Emergency Medicine
NCT03418935Phase 3Apr 3, 2017BioEq, Irkutsk Regional Clinical Hospital, Leningrad Regional Clinical Hospital, Polysan, Ltd., State Budgetary Health Care Institution "City Hospital № 26", St. Petersburg Mechnikov State Medical Academy
NCT03416062Phase 3Apr 3, 2017Avicenna Medical Center, BioEq, Irkutsk Regional Clinical Hospital, Petrov Research Institute of Oncology, Polysan, Ltd., Regional Clinical oncologic center, Omsk region, State Budgetary Health Care Institution "City Hospital № 26", St. Petersburg Mechnikov State Medical Academy
NCT02930161Phase 2Jun 1, 2016BioEq, Government of Russia, Hepatologist Ltd., Military Medical Academy named after SM Kirov, the Russian Ministry of Defense, Hospital Therapeutic Department and Clinic, Moscow State University, Polysan, Ltd., Russian Military, State Novosibirsk Regional Clinical Hospital, St. Petersburg City Hospital of the Holy Martyr Elizabeth, St. Petersburg State Public Medical Institution
Showing 10 of 10 trials
Page 1 / 1

Organizations

Research & Development (29)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Polysan, Ltd.For profit8822016
BioEqFor profit3022016
Irkutsk Regional Clinical HospitalAcademic/Hospital2012017
State Budgetary Health Care Institution "City Hospital № 26"Academic/Hospital2012017
St. Petersburg Mechnikov State Medical AcademyAcademic/Hospital2012017
Avicenna Medical CenterAcademic/Hospital1012017
Baqiyatallah Medical Sciences UniversityAcademic/Hospital1112019
Canadian Critical Care Trials GroupAcademic/Hospital1012019
Canadian Institutes of Health Research (CIHR)Academic/Hospital1012019
East Carolina UniversityAcademic/Hospital1012019
Government of RussiaGovernment1012016
Hamadan University of Medical ScienceAcademic/Hospital1012019
Harvard UniversityAcademic/Hospital1012019
Hepatologist Ltd.Academic/Hospital1012016
Leningrad Regional Clinical HospitalAcademic/Hospital1012017
Military Medical Academy named after SM Kirov, the Russian Ministry of Defense, Hospital Therapeutic Department and ClinicGovernment1012016
Moscow State UniversityAcademic/Hospital1012016
National Institutes of Health (NIH)Government1012019
Petrov Research Institute of OncologyAcademic/Hospital1012017
Regional Clinical oncologic center, Omsk regionAcademic/Hospital1012017
29 organizations
Page 1 / 2

Marketing (1)

OrganizationOrg typeRelationshipDate
Elkins SinnFor profitMKTGNov 16, 1971