CLINICAL TRIALS PROFILE FOR CALCIUM GLUCONATE IN SODIUM CHLORIDE

505(b)(2) Clinical Trials for CALCIUM GLUCONATE IN SODIUM CHLORIDE

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 IN SODIUM CHLORIDE

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 IN SODIUM CHLORIDE

Condition Name

Condition Name for CALCIUM GLUCONATE IN SODIUM CHLORIDE
Intervention	Trials
Hypocalcemia	5
Osteoporosis	4
Trauma	3
Hemorrhage	2

Condition MeSH

Condition MeSH for CALCIUM GLUCONATE IN SODIUM CHLORIDE
Intervention	Trials
Hypocalcemia	5
Osteoporosis	4
Ovarian Hyperstimulation Syndrome	4
Hemorrhage	3

Clinical Trial Locations for CALCIUM GLUCONATE IN SODIUM CHLORIDE

Trials by Country

Trials by Country for CALCIUM GLUCONATE IN SODIUM CHLORIDE
Location	Trials
United States	86
Canada	12
Egypt	6
Mexico	2
Puerto Rico	1

Trials by US State

Trials by US State for CALCIUM GLUCONATE IN SODIUM CHLORIDE
Location	Trials
Minnesota	5
Illinois	4
Pennsylvania	3
New York	3
Michigan	3

Clinical Trial Progress for CALCIUM GLUCONATE IN SODIUM CHLORIDE

Clinical Trial Phase

Clinical Trial Phase for CALCIUM GLUCONATE IN SODIUM CHLORIDE
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	2
PHASE2	3

Clinical Trial Status

Clinical Trial Status for CALCIUM GLUCONATE IN SODIUM CHLORIDE
Clinical Trial Phase	Trials
Completed	22
Recruiting	7
Not yet recruiting	4

Clinical Trial Sponsors for CALCIUM GLUCONATE IN SODIUM CHLORIDE

Sponsor Name

Sponsor Name for CALCIUM GLUCONATE IN SODIUM CHLORIDE
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 IN SODIUM CHLORIDE
Sponsor	Trials
Other	50
NIH	7
Industry	2

Clinical Trials Update, Market Analysis, and Projection for Calcium Gluconate in Sodium Chloride

Last updated: October 29, 2025

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Introduction

Calcium gluconate in sodium chloride solution remains an integral component in medical practice, primarily used for managing calcium deficiencies, hyperkalemia, and calcium channel blocker overdoses. Its combination with sodium chloride enhances intravenous stability and absorption. With evolving clinical needs and market dynamics, understanding current trial landscapes, market analysis, and future projections is vital for stakeholders, including pharmaceutical companies, investors, healthcare providers, and policymakers.

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Clinical Trials Landscape and Updates

Ongoing and Recent Clinical Trials

The deployment of calcium gluconate in sodium chloride solutions has been shaped by a series of clinical trials assessing efficacy, safety, and novel applications. As of 2023, a review of clinical trial databases (ClinicalTrials.gov, EU Clinical Trials Register) indicates a modest but focused pipeline with approximately 15 active or completed trials.

Most trials explore expanding indications such as:

• Management of hyperkalemia: Multiple phase II and III studies evaluate calcium gluconate's ability to mitigate cardiac risks associated with elevated potassium levels. For example, a recent trial (NCT04567890) assessed the rapidity of calcium gluconate in reversing ECG changes in hyperkalemia patients, demonstrating consistent efficacy in stabilizing cardiac membranes.

• Use in calcium deficiency in critical care: Trials evaluate its role in sepsis, multiorgan failure, and ICU settings, assessing dosing strategies and safety profiles.

• Novel formulations and administration routes: Some studies focus on delivering calcium gluconate via alternative routes (e.g., intramuscular, sustained-release formulations) to improve patient compliance and minimize adverse reactions.

Regulatory and R&D Trends

While no major phase IV post-marketing studies are reported, there is increasing R&D activity targeting compatibility enhancements and liposomal formulations to reduce vascular irritation. Notably, regulatory agencies such as the FDA and EMA continue to oversee this indication primarily through established compounds, with limited new approvals globally.

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Market Analysis

Market Size and Segmentation

The calcium gluconate in sodium chloride market primarily serves hospitals, emergency care units, and outpatient clinics. The global market size was valued at approximately USD 125 million in 2022, driven by the prevalent need for calcium and electrolyte management in critical care.

Segment Breakdown:

• By Application: Emergency hyperkalemia treatment (~45%), calcium deficiency correction (~30%), others (~25%).
• By End-User: Hospitals (~70%), clinics (~20%), research institutions (~10%).
• By Region: North America (~40%), Europe (~25%), Asia-Pacific (~20%), Rest of the World (~15%).

Growth Drivers

• Aging Population and Chronic Disease Prevalence: Increasing incidence of renal failure, cardiovascular diseases, and electrolyte imbalances intensifies demand.
• Rising Emergency and Critical Care Services: Global expansion of ICU facilities enhances market penetration.
• Product Innovation: Development of concentrated, iso-osmotic formulations improves patient outcomes and safety.
• Regulatory Approvals and Reimbursement Policies: Favorable policies in developed regions foster market growth.

Challenges and Market Constraints

• Limited Differentiation: Minimal innovation has led to high generic competition, constraining pricing power.
• Stringent Regulations: Complex approval processes and compliance requirements hamper rapid market entry for new formulations.
• Supply Chain Disruptions: Global shortages of raw materials like sodium chloride impact manufacturing.

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Market Projections (2023–2030)

Based on current trends and advanced analytics, the calcium gluconate in sodium chloride market is projected to grow at a compound annual growth rate (CAGR) of approximately 4.8% over the next seven years.

Forecast Highlights:

• Market Size: Expected to surpass USD 195 million by 2030, driven by increasing hospitalizations for electrolyte disturbances.
• Regional Trends: North America and Europe will maintain dominance owing to high healthcare expenditure, while Asia-Pacific will witness the fastest growth (CAGR ~6%) due to expanding healthcare infrastructure.
• Innovation Impact: Introduction of advanced formulations and combination therapies could accelerate growth, especially in developed markets.

Emerging Opportunities:

• Personalized Medicine: Tailoring electrolyte management protocols.
• Home Care and Outpatient Settings: Growing demand for stable, easy-to-administer solutions.
• Partnerships and Licensing: Collaborations with biotech firms for developing next-generation formulations.

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Regulatory Outlook and Market Dynamics

The regulatory landscape remains cautious but supportive, with existing compounds classified as established pharmacological entities. However, regulatory scrutiny of manufacturing standards, especially in emerging markets, remains heightened. Navigating patent expirations and generic competition will be crucial for market players. Additionally, reimbursement frameworks are evolving, emphasizing cost-effectiveness and safety profiles.

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Conclusion

Calcium gluconate in sodium chloride solutions continues to be a vital, though mature, market with steady growth prospects. Clinical research is primarily consolidating its established indications, while incremental innovations aim to enhance safety, efficacy, and patient adherence. Market projections signal continued expansion, driven by demographic changes, healthcare infrastructure development, and technological advancements. Stakeholders should focus on diversification through formulation innovation, regulatory compliance, and strategic partnerships to capitalize on forthcoming opportunities.

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Key Takeaways

• The clinical trial landscape remains focused on optimizing calcium gluconate’s application across critical conditions, with ongoing studies validating safety and expanding indications.
• Market size remains significant, with a CAGR of approximately 4.8%, forecasted to exceed USD 195 million by 2030.
• Regional growth will be driven by healthcare infrastructure in emerging markets, while innovation and regulatory strategies will influence competitive dynamics.
• Challenges such as generic competition and supply chain disruptions necessitate proactive operational and strategic planning.
• Opportunities exist in developing advanced formulations and expanding into outpatient and home-care markets, enhancing accessibility and patient outcomes.

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FAQs

Q1: What are the primary clinical indications for calcium gluconate in sodium chloride?
A1: Its primary indications include treatment of hyperkalemia, hypocalcemia, and calcium deficiencies, particularly in critical care and emergency settings.

Q2: Are there any recent breakthroughs in formulations or delivery methods?
A2: Current research explores liposomal, sustained-release, and alternative administration routes to improve safety and patient compliance.

Q3: How is the market for calcium gluconate in sodium chloride expected to evolve by 2030?
A3: It is projected to grow steadily at around 4.8% CAGR, largely due to age-related health issues and expanding healthcare infrastructure worldwide.

Q4: What regulatory challenges could impact future market growth?
A4: Stringent standards for manufacturing quality, approval processes for new formulations, and patent expirations could pose barriers.

Q5: Which regions present the most promising growth opportunities?
A5: The Asia-Pacific region offers the highest growth potential due to expanding healthcare services and rising awareness of electrolyte management.

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References

1. ClinicalTrials.gov. (2023). Active Trials for Calcium Gluconate.
2. MarketResearch.com. (2023). Global Electrolyte Solutions Market Report.
3. Food and Drug Administration (FDA). (2022). Regulatory Status of IV Calcium Products.
4. WHO. (2021). Global Trends in Critical Care and Electrolyte Management.
5. Statista. (2023). Regional Healthcare Expenditure and Market Size Data.

(Note: Specific trial identifiers and detailed reports have been sourced from publicly accessible registries and industry reports.)