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citric acid

Small moleculeapproved

Approved

Jun 22, 1982

Potassium citrate is indicated for the management of renal tubular acidosis with calcium stones, hypocitraturic calcium oxalate nephrolithiasis of any etiology, uric acid lithiasis with or without calcium stones. WhenPotassium citrate is given orally, the metabolism of absorbed citrate produces an alkaline load. The induced alkaline load in turn increases urinary pH and raises urinary citrate by augmenting citrate clearance without measurably altering ultrafilterable serum citrate. Thus, potassium citrate therapy appears to increase urinary citrate principally by modifying the renal handling of citrate, rather than by increasing the filtered load of citrate. Potassium citrate is used as a food additive (E 332) to regulate acidity. — NCATS

Clinical trial activity

51 trials · 64 clinical orgs · 11 marketing orgs

Phase 1
5
Phase 2
17
Phase 3
8
Phase 4
15

Earliest trial started Sep 30, 2003 (NCT00586131)

Timeline

1980s

  1. Jun 22, 1982

    Baxter — Earliest FDA Approval

  2. Jun 22, 1982

    Baxalta — NDA Secondary Org

  3. Jun 22, 1982

    Baxter — NDA Secondary Org

  4. Jun 22, 1982

    Baxter — NDA Organization

  5. Mar 15, 1984

    Hospira — NDA Secondary Org

1990s

  1. Oct 2, 1990

    United Guardian — NDA Secondary Org

2000s

  1. Dec 17, 2002

    Exalenz Bioscience LTD. — NDA Secondary Org

  2. Dec 17, 2002

    Meridien Research — NDA Secondary Org

  3. Jan 1, 2006

    Earliest Phase 2 Sponsor(trial)

  4. Jan 1, 2008

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Earliest Phase 3 Sponsor(trial)

  2. Jul 16, 2012

    Ferring — NDA Secondary Org

  3. Nov 21, 2016

    Par Pharmaceuticals — Marketing Organization

  4. Nov 21, 2016

    Bristol-Myers Squibb — Marketing Organization

2020s

  1. May 22, 2020

    Evofem Inc. — NDA Secondary Org

  2. Jul 18, 2022

    Hetero Labs Ltd — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedJun 22, 1982

Chemistry & pharmacology

Loading structure…

SMILES

O=C(O)CC(O)(CC(=O)O)C(=O)O
Mol. weight
192.12 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral, Topical
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

Yes

Sources

Also known as

  • 2-hydroxytricarballylic acid
  • 2-hydroxytricarballylic acid
  • 3-carboxy-3-hydroxypentane-1,5-dioic acid
  • 3-carboxy-3-hydroxypentane-1,5-dioic acid
  • anhydrous citric acid
  • citrasate
  • citrate
  • citrate
  • citric acid
  • citric acid
  • citric acid
  • citric acid
  • citric acid
  • citric acid
  • citric acid
  • citric acid
  • citric acid
  • citric acid, anhydrous
  • citric acid, anhydrous
  • citric acid monohydrate
  • citronensäure
  • citronensäure
  • e330
  • e330
  • urologic g

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06987968Phase 2Aug 25, 2025Versantis AG
NCT06580366Phase 4Aug 22, 2024Hitit University
NCT05900050Phase 2Jul 2, 2023Versantis AG
NCT05148494Phase 4Feb 1, 2022Government of Canada
NCT05846139N/AJan 17, 2022Tuscan Dental Institute
NCT04700475N/ASep 4, 2020Cairo University
NCT04035070Phase 4May 31, 2020Cairo University
NCT04161599Phase 4Feb 29, 2020Universidad Autonoma de Barcelona
NCT04483037Phase 4Jan 1, 2020Changhua Christian Hospital
NCT04113382Phase 1/Phase 2 (Phase 2)Oct 31, 2019Ferring
NCT04033250N/AAug 31, 2019Technion University
NCT04741620N/AJan 17, 2019Hospital de Mataró
NCT03716609N/AOct 23, 2018Academia Sinica, Taiwan, Government of Taiwan, Institute of Biomedical Sciences, Academia Sinica, Taipei Veteran General hospital
NCT03593252N/ASep 1, 2018McMaster University
NCT03423329N/AOct 20, 2017Ain Shams University
NCT03999203N/AOct 4, 2017Queen's University, Belfast, University of London
NCT03243305Phase 3Jul 27, 2017Evofem Inc., Parexel
NCT03107377Phase 2May 1, 2017Clinical Research Management, Inc., Evofem Inc.
NCT03017235Phase 3Feb 20, 2017Ferring
NCT02905981Phase 2Oct 1, 2016Rockwell Medical Inc
Showing 20 of 51 trials
Page 1 / 3

Organizations

Research & Development (64)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
FerringFor profit4432014
Ain Shams UniversityAcademic/Hospital2222016
Cairo UniversityAcademic/Hospital2222020
Evofem Inc.For profit2222017
Rockwell Medical IncFor profit2222016
University of BurgundyAcademic/Hospital2212013
University of California, San DiegoAcademic/Hospital2122006
Versantis AGFor profit2212023
Academia Sinica, TaiwanAcademic/Hospital1112018
Apices Soluciones S.L.For profit1012010
AzidusFor profit1112011
British Columbia Cancer AgencyAcademic/Hospital1112014
Brock UniversityAcademic/Hospital1112012
Changhua Christian HospitalAcademic/Hospital1112020
Clinical Research Management, Inc.For profit1012017
CorMedixFor profit1112015
Davita Clinical ResearchFor profit1012015
DentaidAcademic/Hospital1012013
Eyegate Pharmaceuticals, Inc.For profit1112008
Frenova Renal ResearchFor profit1012015
64 organizations
Page 1 / 4

Marketing (12)

OrganizationOrg typeRelationshipDate
BaxaltaFor profitNDA2Jun 22, 1982
BaxterFor profitNDA2Jun 22, 1982
BaxterFor profitNDAJun 22, 1982
Bristol-Myers SquibbFor profitMKTGNov 21, 2016
Evofem Inc.For profitNDA2May 22, 2020
Exalenz Bioscience LTD.For profitNDA2Dec 17, 2002
FerringFor profitNDA2Jul 16, 2012
Hetero Labs LtdFor profitMKTGJul 18, 2022
HospiraFor profitNDA2Mar 15, 1984
Meridien ResearchFor profitNDA2Dec 17, 2002
Par PharmaceuticalsFor profitMKTGNov 21, 2016
United GuardianFor profitNDA2Oct 2, 1990