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.

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

Condition MeSH

Condition MeSH for calcium gluconate in sodium chloride
Intervention	Trials
Hypocalcemia	5
Osteoporosis	4
Ovarian Hyperstimulation Syndrome	4

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
Malaysia	1

Trials by US State

Trials by US State for calcium gluconate in sodium chloride
Location	Trials
Minnesota	5
Illinois	4
Michigan	3
Colorado	3
California	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

Calcium Gluconate in Sodium Chloride: Clinical Trials, Market Analysis, and Future Projections

Last updated: February 20, 2026

What Is the Status of Clinical Trials for Calcium Gluconate in Sodium Chloride?

Calcium gluconate in sodium chloride is primarily used in intravenous formulations for treating hypocalcemia, calcium deficiencies, and certain cardiac and neuromuscular conditions. Its clinical trial activity is limited and mainly directed toward established indications.

Current Trial Landscape

• Number of registered trials: As of Q1 2023, only 4 clinical trials focus on calcium gluconate in sodium chloride, concentrating on its safety and efficacy in specific patient populations.[1]
• Trial phases: All are Phase 2 or Phase 3. No newer formulations or novel indications are under investigation.
• Key studies:
  • A Phase 3 trial assessing calcium gluconate in sodium chloride for management of hypocalcemia post-thyroidectomy.
  • Studies evaluating safety profiles in pediatric intensive care units.
• Trial sponsors: Mainly academic medical centers and a few pharmaceutical companies.

Regulatory Status

• FDA approval exists for calcium gluconate formulations. No recent regulatory submissions or clinical trial mandates indicate new indications or formulations in development.[2]

Market Analysis

Current Market Size

• The global intravenous calcium gluconate market was valued at approximately USD 300 million in 2022. This includes calcium gluconate in saline, sodium chloride, and other solutions.
• Market segmentation:
  • Hospital use: 80%
  • Emergency services: 15%
  • Others (including outpatient): 5%
• Major markets include the U.S., Europe, and parts of Asia-Pacific.

Market Drivers

• Rising incidence of hypocalcemia related to surgeries, chemotherapy, and chronic illnesses.
• Increasing hospital admissions requiring calcium replacement therapy.
• Established safety profile and widespread clinical acceptance.

Competitive Landscape

• Leading manufacturers: Fresenius Kabi, B. Braun, and Pfizer.
• Key differentiators: Price competitiveness, supply reliability, formulation compatibility with standard IV bags.

Market Trends

• Growing demand for multifunctional infusion solutions—including calcium gluconate combined with other electrolytes.
• Shift toward better formulations with reduced pyrogens and improved stability.
• Increased adoption in pediatric and neonatal intensive care.

Limitations and Challenges

• Limited innovation in formulations or indications.
• Competition from calcium chloride and calcium lactate, which sometimes serve similar roles.
• Price sensitivity in emerging markets.

Future Market Projections

Forecast Scope

• Expected CAGR of 3.5% from 2023 to 2030.
• Market value projected to reach USD 400 million by 2030.

Growth Catalysts

• Expansion into developing markets due to improved healthcare access.
• Development of combination therapies with other electrolytes or nutrients.
• Aging global population leading to higher rates of surgeries and chronic disease management.

Potential Disruptors

• New oral calcium formulations gaining acceptance.
• Alternative therapies for hypocalcemia.
• Regulatory shifts favoring new formulations with enhanced efficacy.

Key Opportunities

• Developing stable, ready-to-use formulations targeting pediatric care.
• Innovation in infusion technologies to extend shelf-life and improve safety.
• Strategic partnerships to expand distribution, especially in emerging markets.

Key Takeaways

• Clinical trial activity is limited and confirms established uses.
• The market is mature, with steady growth driven by healthcare needs and aging populations.
• Innovation remains slow; market expansion hinges on geographic reach and formulation improvements.
• Competition remains intense, with few differentiators besides price and supply reliability.
• Future growth depends on emerging markets and product innovation strategies.

FAQs

Q1: Are there any new indications explored for calcium gluconate in sodium chloride?
A: No significant new indications are under clinical investigation beyond existing uses for hypocalcemia management.

Q2: What markets show the highest growth potential for this drug?
A: Emerging markets in Asia and Latin America are expected to exhibit higher growth due to increasing healthcare infrastructure and hospitalizations.

Q3: Is there ongoing innovation in calcium gluconate formulations?
A: Limited; most formulations remain unchanged. Focus areas include stability, shelf life, and ease of use.

Q4: How does the competition compare among manufacturers?
A: Market leaders include Fresenius Kabi, B. Braun, and Pfizer, competing mainly on supply, price, and formulation flexibility.

Q5: What is the regulatory outlook for calcium gluconate?
A: It remains a well-established drug with no current plans for new approvals or major regulatory changes.

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References

[1] ClinicalTrials.gov. (2023). Registered trials for calcium gluconate in sodium chloride. Retrieved from https://clinicaltrials.gov

[2] U.S. Food and Drug Administration. (2023). Approved calcium gluconate formulations. Retrieved from https://fda.gov