Calcium Gluconate

Phase 3Small molecule

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Calcium Gluconate is one of 61 small molecule programs targeting Postpartum Hemorrhage. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Postpartum HemorrhageRecruiting

Blood Loss, SurgicalRecruiting

HemorrhageNot yet recruiting

Postpartum HemorrhagePreclinical

Recruiting

Blood Loss, SurgicalPhase 2

Recruiting

HemorrhagePhase 3

Not yet recruiting

Competition

Competitive Landscape

61 competitors in Hemorrhage

#DrugCompanyPhaseTrials

Eliquis

Bayer Aspirin

Klor-Con

Plavix

Savaysa

Prevacid

Decadron

AAspen Global Incorporated

Approved

1 8

Ketalar

Boehringer Ingelheim

Approved

1 9

Advil

KKenvue Brands

Approved

1 10

Coumadin

AAbbott

Approved

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Not yet recruiting

Study completion

NCT05953376

Phase 2Recruiting

Blood Loss, Surgical

NCT07217899

Q4 2027

PreclinicalRecruiting

Postpartum Hemorrhage

NCT07714902

Q1 2028

Phase 2Recruiting

Trauma

NCT05958342

Clinical

Trials by Indication[1]

Ovarian Hyperstimulation Syndrome2 trials

Cabergoline Versus Calcium Gluconate Infusion in the Prevention of Ovarian Hyperstimulation Syndrome

Completed·—·Phase 2·NCT02875587·170 enrolled

Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention

Completed·—·Phase 3·NCT03473613·230 enrolled

Infusion1 trial

Prophylactic Infusion of Calcium Gluconate Reducing the Rate of Hypocalcaemia After Total Thyroidectomy

Unknown status·UUniversity of Malaya·Phase 4·NCT04491357·50 enrolled

Neurotoxicity1 trial

Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity in Patients With Colon Cancer or Rectal Cancer Receiving Oxaliplatin-Based Combination Chemotherapy

Completed·AAlliance for Clinical Trials in Oncology·Phase 3·NCT01099449·362 enrolled

Prostate CA1 trial

Zolendronate for the Prevention of Bone Loss in Men w/ Prostate CA on Long-Term Androgen Deprivation

Terminated·NNorthwestern University·Phase 3·NCT00058188·53 enrolled

MPA1 trial

Comparative Study Between Calcium Gluconate With Diosmin, Cabergoline and Cabergoline With Diosmin

Completed·MMinia University·N/A·NCT06333691·180 enrolled

12 more indications

Breast Cancer1 trial

Bone Mineral Density in Postmenopausal Women With Primary Breast Cancer Who Are Receiving Treatment on Clinical Trial

Completed·NNCIC Clinical Trials Group·Phase 3·NCT00354302·497 enrolled

Cardiac1 trial

Study of the Relationship Between Calcium Levels and Intact Parathyroid Hormone (iPTH) in Adults With Repaired or Palliated Conotruncal Cardiac Defects

Completed·NNational Center for Research Resources (NCRR)··NCT00004361·150 enrolled

Peripheral Neuropathy1 trial

Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer

Terminated·MMayo Clinic·Phase 3·NCT00998738·1 enrolled

Vitamin D Deficiency1 trial

Vitamin D Deficiency, Muscle Pain, Joint Pain, and Joint Stiffness in Postmenopausal Women Receiving Letrozole For Stage I-III Breast Cancer

Completed·UUniversity of Washington·Phase 2·NCT00416715·100 enrolled

Esophageal Cancer1 trial

Endoscopic Assisted Calcium Electroporation in Esophageal Cancer

Completed·MMichael Patrick Achiam·Phase 1·NCT04958044·10 enrolled

ART1 trial

Pharmacokinetic Equivalence of Calcium Gluconate and Calcium Chloride in Parturients

Completed·SStanford University·Phase 1·NCT05973747·34 enrolled

Hemorrhage1 trial

Calcium Administration in Life-saving Management During Massive Hemorrhage

Not yet recruiting·LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's·Phase 2/3·NCT06820645·81 enrolled

Colorectal Cancer1 trial

Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity Caused By Oxaliplatin in Patients Receiving Combination Chemotherapy for Stage II, Stage III, or Stage IV Colorectal Cancer That Has Been Completely Removed By Surgery

Completed·AAlliance for Clinical Trials in Oncology·Phase 3·NCT00316914·104 enrolled

Trauma1 trial

CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial

Recruiting·JJason Sperry·Phase 2·NCT05958342·1,050 enrolled

Blood Loss, Surgical1 trial

Phase II, Randomized, Double Blinded, Placebo Controlled Superiority Trial of Prophylactic Intravenous Calcium Gluconate to Decrease Blood Loss at Time of Cesarean Delivery in Pregnant Patients at High Risk for Uterine Atony

Recruiting·UUniversity of Michigan·Phase 2·NCT07217899·140 enrolled

Postpartum Hemorrhage1 trial

Administration of Calcium Gluconate for the Reduction of Blood Loss During Vaginal Delivery: A Randomized, Double-Blind, Placebo-Controlled Trial

Recruiting·RRambam Health Care Campus·Preclinical·NCT07714902·710 enrolled

Unspecified1 trial

Empiric Calcium in Massive Transfusion

Not yet recruiting·UUniversity of California, Irvine·Phase 3·NCT05953376·30 enrolled

Regulatory

FDA Approval Timeline[4]

Jun 15, 2017

CALCIUM GLUCONATE

NDA NDA208418

Oct 29, 2018

CALCIUM GLUCONATE IN SODIUM CHLORIDE

NDA NDA210906

Sources

References

[1]
ClinicalTrials.gov — 18 trial records for Calcium Gluconate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Calcium Gluconate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Calcium Gluconate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA210906). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Calcium Gluconate. U.S. Food & Drug Administration.
[6]
SEC EDGAR — McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Patent Landscape[5]

Patent Cliff

Jul 25, 2037

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10130646Jul 25, 2037

10342813Jul 25, 2037

Calcium Gluconate

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Q1 2028

Trials by Indication[1]

Ovarian Hyperstimulation Syndrome2 trials

Infusion1 trial

Neurotoxicity1 trial

Prostate CA1 trial

MPA1 trial

Breast Cancer1 trial

Cardiac1 trial

Peripheral Neuropathy1 trial

Vitamin D Deficiency1 trial

Esophageal Cancer1 trial

ART1 trial

Hemorrhage1 trial

Colorectal Cancer1 trial

Trauma1 trial

Blood Loss, Surgical1 trial

Postpartum Hemorrhage1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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