calcium gluconate

Small moleculeapproved

Approved

Jun 15, 2017

Calcium gluconate is the calcium salt of gluconic acid and is used as a mineral supplement and medication. As a medication it is used by injection into a vein to treat low blood calcium, high blood potassium, and magnesium toxicity. Supplementation is generally only required when there is not enough calcium in the diet. Supplementation may be done to treat or prevent osteoporosis or rickets. It can also be taken by mouth but is not recommended for injection into a muscle. — Wikipedia

Clinical trial activity

11 trials · 13 clinical orgs · 8 marketing orgs

Phase 1
3
Phase 2
4
Phase 3
3
Phase 4
1

Earliest trial started Oct 1, 2014 (NCT03473613)

Timeline

2010s

  1. Jan 1, 2014

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2017

    Earliest Phase 1 Sponsor(trial)

  3. Jun 15, 2017

    Fresenius — Earliest FDA Approval

  4. Jun 15, 2017

    Fresenius — Marketing Organization

  5. Jun 15, 2017

    Fresenius — NDA Organization

  6. Oct 29, 2018

    Hq Speciality Pharma — Marketing Organization

2020s

  1. Oct 14, 2022

    Nivagen Pharmaceuticals Inc. — Marketing Organization

  2. Aug 21, 2023

    B. Braun — Marketing Organization

  3. Sep 5, 2023

    Amneal Pharmaceuticals — Marketing Organization

  4. Oct 19, 2023

    Somerset Pharmaceuticals — Marketing Organization

  5. Jan 1, 2024

    Earliest Phase 2 Sponsor(trial)

  6. Dec 30, 2025

    Sagent Pharmaceuticals, Inc. — Marketing Organization

  7. May 4, 2026

    Caplin Point Laboratories — Marketing Organization

Indications

Mechanism of action

  • CalciumSupplementation

    Calcium supplementation

Approval history

  • approvedJun 15, 2017

Chemistry & pharmacology

Loading structure…

SMILES

O=C([O-])[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO.O=C([O-])[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO.[Ca+2]
Mol. weight
430.37 g/mol
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07217899Phase 2Oct 20, 2025University of Michigan
NCT06820645Phase 2/Phase 3 (Phase 3)May 1, 2025London Health Sciences Centre, University of Western Ontario
NCT05958342Phase 2Mar 31, 2024Department of Defense, University of Pittsburgh
NCT05953376Phase 3Jan 31, 2024University of California, Irvine
NCT06235749N/ANov 14, 2023Technion University
NCT05973747Early Phase 1 (Phase 1)Sep 1, 2023Stanford University
NCT06333691N/AOct 1, 2022Minia University
NCT04958044Phase 1Jul 12, 2021University of Copenhagen
NCT04491357Phase 4Jun 1, 2020University of Malaya
NCT03543917Phase 1Aug 8, 2017Fundatia Bio-Forum
NCT03473613Phase 3Oct 1, 2014Benha University
Showing 11 of 11 trials
Page 1 / 1

Organizations

Research & Development (13)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Benha UniversityAcademic/Hospital1112014
Department of DefenseGovernment1012024
Fundatia Bio-ForumFor profit1112017
London Health Sciences CentreAcademic/Hospital1112025
Minia UniversityAcademic/Hospital1112022
Stanford UniversityAcademic/Hospital1112023
Technion UniversityAcademic/Hospital1112023
University of California, IrvineAcademic/Hospital1112024
University of CopenhagenAcademic/Hospital1112021
University of MalayaAcademic/Hospital1112020
University of MichiganAcademic/Hospital1112025
University of PittsburghAcademic/Hospital1112024
University of Western OntarioAcademic/Hospital1012025
13 organizations
Page 1 / 1

Marketing (11)

OrganizationOrg typeRelationshipDate
Amneal PharmaceuticalsFor profitSYNSep 5, 2023
Amneal PharmaceuticalsFor profitMKTGSep 5, 2023
B. BraunFor profitMKTGAug 21, 2023
B. BraunFor profitSYNAug 21, 2023
Caplin Point LaboratoriesFor profitMKTGMay 4, 2026
FreseniusFor profitMKTGJun 15, 2017
FreseniusFor profitNDAJun 15, 2017
Hq Speciality PharmaFor profitMKTGOct 29, 2018
Nivagen Pharmaceuticals Inc.For profitMKTGOct 14, 2022
Sagent Pharmaceuticals, Inc.For profitMKTGDec 30, 2025
Somerset PharmaceuticalsFor profitMKTGOct 19, 2023