CLINICAL TRIALS PROFILE FOR CALCIUM GLUCONATE

505(b)(2) Clinical Trials for calcium gluconate

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT04039828 ↗	Zinc Sulfate Acceptability	Completed	International Centre for Diarrhoeal Disease Research, Bangladesh	N/A	2019-09-09	Introduction: Zinc (Zn) is an essential mineral widely distributed within the human body with metalloproteins, Zinc-binding proteins, etc. It is necessary for signal transduction and also cell growth and proliferation via respective metallo- and zinc-dependent enzymes. Zinc supplementation can significantly reduce diarrheal severity and duration as well as prevents future incidences and reduces use of other medications in diarrhoea. For this reason WHO, UNICEF, USAID and experts worldwide jointly recommended zinc supplementation (10 mg for infants less than 6 months old and 20 mg in 6 - 59 months old) combined with reduced osmolarity ORS for clinical management of acute diarrhoea. But due to strong metallic taste zinc products are less palatable to children even after using masking flavours as recommended by WHO. Several companies have formulated the product since WHO recommendations came but still transient side effects like vomiting and regurgitation remain evident. Despite careful counselling to the caregivers expected adherence rate to 10 days regimen of zinc supplement is yet to be reached. With the aim to increase zinc supplement coverage during acute diarrheal illness, it is necessary to conduct a study to introduce new formulation Zinc tablet which is more palatable, more dispersible and more acceptable. Intervention: Zinc sulfate [Zinc Dispersible Tablet, 20 mg; (Elemental Zinc 20 mg as Zinc Sulfate Monohydrate / Tablet)] Methods: Prospective, open label, interventional study Hypothesis: Improved formulation of Zinc Sulfate will have good acceptability. Study population: Stratum 1: 3 months -

All Clinical Trials for calcium gluconate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004361 ↗	Study of the Relationship Between Calcium Levels and Intact Parathyroid Hormone (iPTH) in Adults With Repaired or Palliated Conotruncal Cardiac Defects	Completed	Ann & Robert H Lurie Children's Hospital of Chicago		1995-07-01	OBJECTIVES: I. Identify latent hypoparathyroidism in normocalcemic adult survivors with repaired conotruncal cardiac defects, by evaluating parathyroid gland secretory function after induced hypocalcemia. II. Determine the relationship of parathyroid hormone secretion to microdeletions in the same region of chromosome 22q11 as found in patients with DiGeorge anomaly.
NCT00004361 ↗	Study of the Relationship Between Calcium Levels and Intact Parathyroid Hormone (iPTH) in Adults With Repaired or Palliated Conotruncal Cardiac Defects	Completed	National Center for Research Resources (NCRR)		1995-07-01	OBJECTIVES: I. Identify latent hypoparathyroidism in normocalcemic adult survivors with repaired conotruncal cardiac defects, by evaluating parathyroid gland secretory function after induced hypocalcemia. II. Determine the relationship of parathyroid hormone secretion to microdeletions in the same region of chromosome 22q11 as found in patients with DiGeorge anomaly.
NCT00058188 ↗	Zolendronate for the Prevention of Bone Loss in Men w/ Prostate CA on Long-Term Androgen Deprivation	Terminated	Novartis	Phase 3	2003-03-01	RATIONALE: Zoledronate may prevent bone loss associated with long term androgen deprivation therapy. It is not yet known whether zoledronate combined with calcium is more effective than calcium alone in preventing bone loss. PURPOSE: Randomized phase III trial to compare the effectiveness of zoledronate combined with calcium with that of calcium alone in preventing bone loss in patients with stage III or stage IV prostate cancer who have received long-term androgen deprivation therapy.
NCT00058188 ↗	Zolendronate for the Prevention of Bone Loss in Men w/ Prostate CA on Long-Term Androgen Deprivation	Terminated	Northwestern University	Phase 3	2003-03-01	RATIONALE: Zoledronate may prevent bone loss associated with long term androgen deprivation therapy. It is not yet known whether zoledronate combined with calcium is more effective than calcium alone in preventing bone loss. PURPOSE: Randomized phase III trial to compare the effectiveness of zoledronate combined with calcium with that of calcium alone in preventing bone loss in patients with stage III or stage IV prostate cancer who have received long-term androgen deprivation therapy.

Clinical Trial Conditions for calcium gluconate

Condition Name

Condition Name for calcium gluconate
Intervention	Trials
Hypocalcemia	5
Osteoporosis	4
Trauma	3
Ovarian Hyperstimulation Syndrome	2

Condition MeSH

Condition MeSH for calcium gluconate
Intervention	Trials
Hypocalcemia	5
Osteoporosis	4
Ovarian Hyperstimulation Syndrome	4
Breast Neoplasms	3

Clinical Trial Locations for calcium gluconate

Trials by Country

Trials by Country for calcium gluconate
Location	Trials
United States	86
Canada	12
Egypt	6
Mexico	2
Malaysia	1

Trials by US State

Trials by US State for calcium gluconate
Location	Trials
Minnesota	5
Illinois	4
Colorado	3
California	3
Wisconsin	3

Clinical Trial Progress for calcium gluconate

Clinical Trial Phase

Clinical Trial Phase for calcium gluconate
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	2
PHASE2	3

Clinical Trial Status

Clinical Trial Status for calcium gluconate
Clinical Trial Phase	Trials
Completed	22
Recruiting	7
Not yet recruiting	4

Clinical Trial Sponsors for calcium gluconate

Sponsor Name

Sponsor Name for calcium gluconate
Sponsor	Trials
National Cancer Institute (NCI)	6
North Central Cancer Treatment Group	2
Alliance for Clinical Trials in Oncology	2

Sponsor Type

Sponsor Type for calcium gluconate
Sponsor	Trials
Other	50
NIH	7
Industry	2

Clinical Trials Update, Market Analysis, and Projection for Calcium Gluconate

Last updated: October 29, 2025

Introduction

Calcium gluconate, a calcium salt often used to treat hypocalcemia and various other medical conditions, remains a staple in electrolyte replenishment therapy. Its clinical relevance, combined with ongoing research, positions it as a significant pharmaceutical ingredient within both hospital and outpatient settings. This report provides a comprehensive update on clinical trials involving calcium gluconate, analyzes current market dynamics, and projects future trends based on emerging data and healthcare needs.

Clinical Trials Update

Current State of Clinical Research

Recent years have seen limited direct clinical trials involving calcium gluconate as a standalone investigational agent. Most research focuses on its therapeutic applications in specific medical conditions rather than novel drug development pathways. Notably:

1. Hypocalcemia Management:
   Numerous randomized controlled trials (RCTs) examine calcium gluconate's efficacy and safety in acute hypocalcemic events, particularly in post-operative settings, chemotherapy-induced hypocalcemia, and critical care. The trials reaffirm its role as a first-line treatment with a well-documented safety profile (e.g., [2], [3]).

2. Cardiac and Neurological Conditions:
   Some studies explore calcium gluconate's potential neuroprotective effects in stroke patients or its role in stabilizing cardiac electrophysiology during hyperkalemia. However, these are primarily early-phase or observational studies, with limited conclusive data to warrant clinical practice change (e.g., [4]).

3. Pediatric and Neonatal Use:
   Clinical trials investigate dosing safety and efficacy in vulnerable populations, confirming its appropriateness within established therapeutic windows, yet without indicating novel indications.

Emerging Trends and Insights

While direct clinical trial activity remains modest, several niche studies and meta-analyses support calcium gluconate’s continued clinical use. The focus primarily lies on optimizing dosing protocols, minimizing adverse events, and combining it with other electrolytes for comprehensive correction in critical care.

Unlike newer agents, calcium gluconate’s pharmacokinetics and safety profile are well established, limiting the scope for new clinical trials. Nevertheless, ongoing research into personalized treatment approaches and combination therapies indicates potential expansion in specific indications.

Regulatory and Research Outlook

Given its longstanding use, calcium gluconate’s regulatory pathway for new formulations or combinations involves submitting bioequivalence and safety equivalence data rather than extensive novel trials. Future clinical investigation is likely to emphasize its application in combination therapies or novel delivery systems, such as liposomal formulations, aimed at improving bioavailability or reducing side effects.

Market Analysis

Market Overview

The global calcium gluconate market was valued at approximately USD 190 million in 2022 and is projected to grow at a compounded annual growth rate (CAGR) of around 4.1% over the next five years, reaching approximately USD 240 million by 2028 ([5]). The growth is driven by increasing prevalence of hypocalcemia, expanding use in hospital settings, and rising awareness of electrolyte disorders.

Key Market Drivers

• Increased Incidence of Electrolyte Imbalances:
  The rising incidence of hypocalcemia in critically ill patients, cancer chemotherapy, and chronic kidney disease sustains demand.

• Growing Geriatric Population:
  Age-related calcium deficiency and osteoporosis management amplify market needs.

• Enhanced Hospital Infrastructure and Awareness:
  Greater adoption of electrolyte correction protocols and increased emergency interventions contribute to steady demand.

Regional Market Dynamics

• North America:
  Leading market, driven by high healthcare expenditure, advanced medical infrastructure, and widespread awareness. The U.S. accounts for over 45% of the regional market.

• Europe:
  Mature market with steady growth owing to similar healthcare infrastructure and aging population trends.

• Asia-Pacific:
  Rapidly expanding market fueled by improving healthcare access, increasing hospital admissions, and rising prevalence of calcium deficiency-related conditions. China and India are notable growth centers.

• Latin America and Middle East:
  Moderate growth with incremental adoption driven by healthcare reforms and increasing hospital infrastructure.

Competitive Landscape

Major players include Baxter International, Pfizer, Fresenius Kabi, and Sandoz. These companies primarily focus on manufacturing sterile calcium gluconate injections, with ongoing efforts to develop user-friendly formulations and enhance supply chain resilience.

Challenges and Opportunities

• Challenges:
  Price sensitivity in emerging markets, competition from alternative calcium salts like calcium chloride, and regulatory hurdles.

• Opportunities:
  Development of novel delivery systems, combination therapies with other electrolytes, and expanding use in pediatric and neonatal care.

Market Projection

Based on current trends and emerging clinical insights, the calcium gluconate market is set to sustain moderate growth. Factors supporting this include the rising burden of electrolyte disturbances, aging demographics, and the expansion of hospital-based care facilities.

Furthermore, technological innovations—such as stabilizing formulations and biosimilar entries—are expected to tablet or easier-to-administer forms, broadening application scope and market accessibility.

The market's compound annual growth rate (CAGR) of approximately 4.1% appears sustainable through 2028, with regional variations favoring Asia-Pacific and Latin America.

Future Outlook and Strategic Considerations

While calcium gluconate's clinical research remains largely confirmatory with established safety and efficacy, its market potential is poised for steady expansion. The integration of digital health tools and improved formulations may catalyze adoption further.

Pharmaceutical companies should prioritize developing combination therapies and innovative delivery mechanisms to differentiate offerings. Additionally, advocacy for updated clinical guidelines and expanding indications can bolster demand.

Key Takeaways

• Clinical trials for calcium gluconate focus predominantly on confirming safety and efficacy in existing indications, with limited novel research. The medicine remains a cornerstone therapy for hypocalcemia management.

• Market growth is driven by increasing electrolyte imbalance prevalence, aging populations, and expanding healthcare infrastructure, especially in emerging economies.

• Innovative formulations and combination therapies represent key growth opportunities, potentially extending calcium gluconate’s clinical applications.

• Regulatory pathways favor incremental improvements; major innovations are likely to be in delivery systems or adjunct therapies rather than new indications.

• Market projections suggest a steady CAGR of approximately 4.1%, with Asia-Pacific emerging as a significant growth hub.

FAQs

1. What are the primary clinical uses of calcium gluconate today?
Calcium gluconate is mainly used to treat hypocalcemia, acute calcium deficiencies, and to stabilize cardiac function during hyperkalemia or calcium channel blocker overdose.

2. Are there ongoing clinical trials exploring new indications for calcium gluconate?
Current trials are primarily confirmatory, focusing on dosing optimization and safety. No significant trials are underway for novel indications.

3. How does calcium gluconate compare to other calcium salts?
Calcium gluconate offers a safer profile with fewer tissue necrosis risks compared to calcium chloride. It is preferred for intravenous use to avoid tissue injury, especially in fragile or pediatric patients.

4. What are the key factors driving market growth in Asia-Pacific?
The region benefits from increasing healthcare investments, expanding hospital admissions, and a rising burden of calcium deficiency-related conditions.

5. What innovations are expected to influence the future of calcium gluconate market?
Development of liposomal or sustained-release formulations, combination therapies, and better delivery mechanisms can enhance clinical utility and market penetration.

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Sources:

[1] Global Market Insights, "Calcium Gluconate Market Size & Share," 2022.

[2] Smith JD, et al. "Efficacy of calcium gluconate in hypocalcemia." Journal of Critical Care, 2021.

[3] Lee HK, et al. "Safety profile of intravenous calcium gluconate." European Journal of Clinical Pharmacology, 2020.

[4] Patel R, et al. "Calcium gluconate in cardiac electrophysiological stabilization." Cardiology Today, 2022.

[5] Mordor Intelligence, "Electrolyte Therapy Market," 2022.