CDEK by Data4ThePeople
Sign in Sign up
← All drugs Report issue

potassium citrate

Trade name: urocit-k

Small moleculeapprovedOrphan Drug FDA

Approved

Aug 30, 1985

Potassium citrate (also known as tripotassium citrate) is a potassium salt of citric acid with the molecular formula K3C6H5O7. It is a white, hygroscopic crystalline powder. It is odorless with a saline taste. It contains 38.28% potassium by mass. In the monohydrate form, it is highly hygroscopic and deliquescent. — Wikipedia

Clinical trial activity

38 trials · 50 clinical orgs · 14 marketing orgs

Phase 1
3
Phase 2
11
Phase 3
11
Phase 4
9

Earliest trial started Apr 1, 1995 (NCT00004284)

Timeline

1980s

  1. Nov 1, 1984

    Orphan Drug Designation

  2. Aug 30, 1985

    Mission Pharmacal — Earliest FDA Approval

  3. Aug 30, 1985

    Mission Pharmacal — NDA Organization

  4. Oct 13, 1988

    The University of Texas, Dallas — NDA Secondary Org

1990s

  1. Jan 1, 1995

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jun 8, 2006

    Rising Pharmaceuticals — Marketing Organization

  2. Jun 8, 2006

    Rocky Mountain Labs — Marketing Organization

  3. Jan 1, 2007

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Aug 6, 2014

    Zydus Discovery DMCC — Marketing Organization

  2. Sep 11, 2017

    Strides Pharma Science — Marketing Organization

  3. Mar 5, 2018

    Teva — Marketing Organization

2020s

  1. Jan 14, 2020

    Ani Pharmaceuticals — Marketing Organization

  2. Jun 29, 2020

    Bionpharma Inc — Marketing Organization

  3. Jan 1, 2021

    The University of Texas, Dallas — Earliest Phase 1 Sponsor(trial)

  4. Feb 5, 2021

    Ascent Pharmahealth — Marketing Organization

  5. Feb 5, 2021

    AbbVie — Marketing Organization

  6. Feb 19, 2021

    Eywa Pharma — Marketing Organization

  7. Feb 19, 2021

    HIBROW HLTHCARE — Marketing Organization

  8. Feb 6, 2024

    Torrent Pharmaceuticals Limited — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

  • CalciumBINDING AGENT

    Calcium binding agent

Approval history

  • approvedPriority reviewAug 30, 1985

Chemistry & pharmacology

Loading structure…

SMILES

O.O=C([O-])CC(O)(CC(=O)[O-])C(=O)[O-].[K+].[K+].[K+]
Mol. weight
324.41 g/mol
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • cymaclear
  • e332
  • e332
  • effercitrate
  • potassium citrate
  • potassium citrate
  • potassium citrate
  • potassium citrate
  • potassium citrate
  • potassium citrate
  • potassium citrate
  • potassium citrate
  • potassium citrate
  • potassium citrate anhydrous
  • potassium citrate anhydrous
  • potassium citrate anhydrous
  • potassium citrate anhydrous
  • potassium citrate anhydrous
  • pot cit
  • pot cit eff
  • sterofundin
  • sterofundin
  • tripotassium citrate
  • tripotassium citrate
  • tripotassium citrate
  • urocit-k
  • urocit-k
  • urocit-k
  • urocit-k 5meq

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07239713N/ANov 15, 2025CMH Lahore Medical College, Pakistan Army
NCT07202832N/AOct 15, 2025Assiut University
NCT06819111Phase 1Jul 1, 2025The University of Texas, Dallas
NCT06819553Phase 2/Phase 3 (Phase 3)Nov 3, 2024Zagazig University
NCT06335537Phase 1Oct 31, 2024University of California, Irvine
NCT06966635Phase 4Apr 10, 2024Fudan University
NCT05918029Phase 2/Phase 3 (Phase 3)Nov 30, 2023Columbia University, University of Pittsburgh, University of Utah, Yeshiva University
NCT06003348Phase 4Oct 11, 2023The University of Texas, Dallas
NCT05389995N/AAug 1, 2022Northwestern University
NCT04651088Early Phase 1 (Phase 1)Dec 1, 2021The University of Texas, Dallas
NCT04095975Phase 4Aug 28, 2019University of Wisconsin
NCT03831152Phase 3Aug 15, 2019Advicenne Pharma, Emory University
NCT04422184Phase 4Jul 29, 2019University of Sao Paulo
NCT03809884Phase 3Feb 28, 2019University of Ottawa
NCT04147871Phase 2/Phase 3 (Phase 3)Feb 1, 2019Advicenne Pharma
NCT04137978Phase 2/Phase 3 (Phase 3)Feb 1, 2019Advicenne Pharma
NCT03644706Phase 3Oct 30, 2018Advicenne Pharma, CTI Clinical Trial and Consulting Services, Emory University
NCT03342456Phase 4Dec 13, 2017Central South University, Livzon Pharmaceutical Group Inc., Yung Shin Pharm. Ind. Co., Ltd.
NCT03281928N/AOct 1, 2017University of Chicago
NCT03253172N/AJul 1, 2017Dutch Kidney Foundation, Erasmus University Rotterdam, Leiden University, University of Amsterdam
Showing 20 of 38 trials
Page 1 / 2

Organizations

Research & Development (50)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
The University of Texas, DallasAcademic/Hospital8641995
Advicenne PharmaFor profit4412018
Emory UniversityAcademic/Hospital2012018
Mahidol UniversityAcademic/Hospital2212014
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government2021995
Assiut UniversityAcademic/Hospital1112025
B. BraunFor profit1012003
Central South UniversityAcademic/Hospital1112017
CMH Lahore Medical CollegeAcademic/Hospital1112025
Columbia UniversityAcademic/Hospital1012023
Cornell UniversityAcademic/Hospital1112006
CTI Clinical Trial and Consulting ServicesFor profit1012018
Dawnrays Pharmaceutical (Holdings) LimitedAcademic/Hospital1112016
Dutch Kidney FoundationAcademic/Hospital1012017
Erasmus University RotterdamAcademic/Hospital1112017
Friedrich Schiller UniversityAcademic/Hospital1012003
Fudan UniversityAcademic/Hospital1112024
German Federal Ministry of Education and ResearchGovernment1012003
Huazhong University of Science and TechnologyAcademic/Hospital1012016
Johns Hopkins UniversityAcademic/Hospital1012006
50 organizations
Page 1 / 3

Marketing (16)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGFeb 5, 2021
Ani PharmaceuticalsFor profitMKTGJan 14, 2020
Ani PharmaceuticalsFor profitSYNJan 14, 2020
Ascent PharmahealthFor profitMKTGFeb 5, 2021
Bionpharma IncFor profitMKTGJun 29, 2020
Bionpharma IncFor profitSYNJun 29, 2020
Eywa PharmaFor profitMKTGFeb 19, 2021
HIBROW HLTHCAREFor profitMKTGFeb 19, 2021
Mission PharmacalFor profitNDAAug 30, 1985
Rising PharmaceuticalsFor profitMKTGJun 8, 2006
Rocky Mountain LabsAcademic/HospitalMKTGJun 8, 2006
Strides Pharma ScienceFor profitMKTGSep 11, 2017
TevaFor profitMKTGMar 5, 2018
The University of Texas, DallasAcademic/HospitalNDA2Oct 13, 1988
Torrent Pharmaceuticals LimitedFor profitMKTGFeb 6, 2024
Zydus Discovery DMCCFor profitMKTGAug 6, 2014