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.
NCT00316914 ↗	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	National Cancer Institute (NCI)	Phase 3	2006-01-01	RATIONALE: Calcium gluconate and magnesium sulfate may prevent or lessen neurotoxicity caused by oxaliplatin. It is not yet known whether calcium gluconate and magnesium sulfate are more effective than a placebo in preventing neurotoxicity caused by oxaliplatin in patients receiving combination chemotherapy. PURPOSE: This randomized phase III trial is studying calcium gluconate and magnesium sulfate to see how well they work compared to a placebo 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.
NCT00316914 ↗	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	North Central Cancer Treatment Group	Phase 3	2006-01-01	RATIONALE: Calcium gluconate and magnesium sulfate may prevent or lessen neurotoxicity caused by oxaliplatin. It is not yet known whether calcium gluconate and magnesium sulfate are more effective than a placebo in preventing neurotoxicity caused by oxaliplatin in patients receiving combination chemotherapy. PURPOSE: This randomized phase III trial is studying calcium gluconate and magnesium sulfate to see how well they work compared to a placebo 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.
NCT00316914 ↗	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	Alliance for Clinical Trials in Oncology	Phase 3	2006-01-01	RATIONALE: Calcium gluconate and magnesium sulfate may prevent or lessen neurotoxicity caused by oxaliplatin. It is not yet known whether calcium gluconate and magnesium sulfate are more effective than a placebo in preventing neurotoxicity caused by oxaliplatin in patients receiving combination chemotherapy. PURPOSE: This randomized phase III trial is studying calcium gluconate and magnesium sulfate to see how well they work compared to a placebo 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.

Clinical Trial Conditions for CALCIUM GLUCONATE

Condition Name

Condition Name for CALCIUM GLUCONATE
Intervention	Trials
Hypocalcemia	5
Osteoporosis	4
Trauma	3
Prostate Cancer	2

Condition MeSH

Condition MeSH for CALCIUM GLUCONATE
Intervention	Trials
Hypocalcemia	5
Osteoporosis	4
Ovarian Hyperstimulation Syndrome	4
Hemorrhage	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
Bangladesh	1

Trials by US State

Trials by US State for CALCIUM GLUCONATE
Location	Trials
Minnesota	5
Illinois	4
New York	3
Michigan	3
Colorado	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

Calcium Gluconate: Clinical Trials Update, Market Analysis and Projection

Last updated: April 28, 2026

What does “calcium gluconate” cover in clinical use?

Calcium gluconate is a calcium salt used for acute and chronic calcium-related indications, most prominently in emergency care for conditions requiring calcium supplementation (for example, hypocalcemia). Clinical programs and regulatory dossiers for calcium gluconate typically focus on formulation, route of administration (IV vs oral), and indication labeling rather than novel mechanism-of-action, because calcium gluconate is a well-established generic active ingredient.

Because “calcium gluconate” is not a single proprietary, mechanism-defined drug candidate but a legacy salt with broad generic availability, the market and trial landscape is dominated by (1) generics and (2) formulation lifecycle management (bioavailability, stability, injection concentration, and delivery system). That structure drives the economics: pricing is low, competitive intensity is high, and “new entrants” are usually reformulations or brand renewals rather than new clinical endpoints.

How many clinical trials are active or recently updated?

No complete, authoritative, cross-registry clinical-trial count for “calcium gluconate” can be produced from the information available in this workspace. A reliable update requires querying trial registries (for example, ClinicalTrials.gov, EU CTR, WHO ICTRP) with a unified strategy (drug substance, synonyms, route filters, and “calcium gluconate” ATC/INN mapping). With no registry feed provided here, any numeric trial counts would not meet an accuracy standard appropriate for R&D and investment decisions.

What clinical trial patterns dominate for calcium gluconate?

Even without a registry-wide count, trial design patterns for calcium salts are consistent across published and registered studies:

• Acute IV use: studies and post-marketing evidence focus on safety, infusion practice, extravasation and local tolerability, and correction of serum calcium in acute care settings.
• Hypocalcemia: endpoints center on changes in serum calcium (total and/or ionized), time to target range, and recurrence.
• Secondary indications: calcium salts sometimes appear in supportive protocols (for example, prevention or correction contexts), with primary endpoints tied to the underlying disease and calcium response as a secondary measure.

For market projection, this matters because clinical demand is largely tied to acute care protocols, hospital formularies, and guideline-concordant dosing, not to differentiation from competitors.

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How big is the calcium gluconate market by value, and where does growth come from?

A credible market sizing and forecast requires a defined segmentation framework and at least one primary pricing datapoint source (for example, IQVIA or other paid datasets) plus volume assumptions. No market-size source is available in this workspace, so generating a numeric market TAM/SAM/SOM would be non-compliant with the accuracy standard demanded here.

What can be stated from the structure of the market:

• Supply structure: calcium gluconate injection and tablets are extensively generic. Competition is mainly on manufacturing scale, batch compliance, supply reliability, and packaging/label claims.
• Demand structure: demand tracks acute care headwinds and chronic calcium use in specific patient groups, but the pricing ceiling is strong because generics compete directly.
• Value drivers: new revenue typically comes from (1) incremental label expansions, (2) formulation improvements that enable preferred use in hospitals, (3) supply-chain stabilization and tender wins, and (4) regulatory transitions that consolidate market access among fewer suppliers.

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What is the competitive landscape and how do launches typically happen?

Because calcium gluconate is not typically patented as a novel drug, competition centers on:

• Generic injection brands (different concentrations and pack sizes)
• Oral formulations (tablets, syrups) with stability and acceptability improvements
• Regulatory filings and lifecycle management: renewals, line extensions, and manufacturing site changes

Key practical point for investment or R&D planning: differentiation must be anchored in tangible procurement advantages (tender eligibility, shelf life, concentration, IV administration usability) or in a narrower clinical niche where labeling and protocol integration matter.

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What are the likely regulatory and reimbursement dynamics?

For legacy generics like calcium gluconate:

• Regulatory pathway is generally abbreviated for new entrants where bioequivalence and chemistry are standard.
• Reimbursement is typically governed by national formularies and hospital procurement contracts.
• Uptake risk is lower than for novel therapeutics but margin pressure is structurally high because procurement tends to favor lowest landed cost unless there is a demonstrated usability or stability advantage.

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Market projection: what scenarios typically shape 3 to 7 year outcomes?

Without verified market base-year and forecast inputs, the only accurate way to project is scenario logic tied to operational levers. Typical scenario drivers for calcium gluconate suppliers include:

Base case (most common)

• Growth tracks healthcare utilization and hospital purchasing volumes.
• Pricing stays flat-to-down because of generic competition.
• Share shifts come from supply reliability and procurement contract cycles.

Upside case

• A supplier wins larger tender allocations (improved supply reliability, reduced stock-outs, or preferred pack formats).
• A formulation improves infusion workflow or stability, moving the product from “used when needed” to preferred protocol status in certain settings.

Downside case

• Price compression accelerates due to additional generics entering procurement lists.
• Manufacturing disruptions or quality events increase rejection rates and reduce effective sales volume.

For business planning, the main forecast variable is usually net sales realized through procurement, not volume alone.

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Where do investors and R&D teams focus for calcium gluconate?

Given the absence of a typical “pipeline” of novel clinical development, best-fit efforts cluster into:

1. Formulation and delivery: higher concentration IV products, stability-enhanced packs, ready-to-administer formats.
2. Manufacturing competitiveness: site capacity, batch yield, compliance track record, and supply continuity.
3. Label and protocol integration: evidence packages that support guideline-aligned use in acute settings.

Clinical trial spend is more likely aimed at:

• pharmacokinetic/bioequivalence where relevant,
• safety and tolerability in specific populations,
• or small pragmatic studies that help hospitals select preferred formulations.

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Key Takeaways

• Calcium gluconate is a legacy calcium salt; the market is structurally generic and procurement-driven.
• A numerically precise “clinical trials update” and “market projection” cannot be produced to a high accuracy standard without trial registry and market sizing sources.
• Revenue growth, where it occurs, is mainly driven by tender wins, supply reliability, pack and concentration preferences, and label/protocol positioning rather than novel clinical differentiation.

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FAQs

1) Is calcium gluconate a patented, pipeline-style drug?

No. It is a well-established active ingredient with extensive generic availability, so most competitive activity centers on formulation and lifecycle management rather than proprietary mechanism-based development.

2) What endpoints matter in calcium gluconate trials?

Trials typically measure correction of serum calcium (total and or ionized), time to target, and safety tied to route of administration, especially for IV use.

3) What drives pricing in calcium gluconate?

Pricing is dominated by generic competition and hospital procurement tender dynamics rather than premium clinical differentiation.

4) What is the most common commercialization lever?

Supply reliability and tender eligibility, paired with practical usability factors like concentration, stability, and pack format.

5) What is the most realistic growth path?

Share gains through procurement cycles and formulation preference, with overall market growth tied to healthcare utilization rather than disease-modifying innovation.

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References

[1] ClinicalTrials.gov. (n.d.). Search results for “calcium gluconate”. https://clinicaltrials.gov/
[2] European Medicines Agency. (n.d.). European public assessment reports and product information for calcium salts. https://www.ema.europa.eu/
[3] WHO ICTRP. (n.d.). International Clinical Trials Registry Platform search for calcium gluconate. https://trialsearch.who.int/