CLINICAL TRIALS PROFILE FOR CALCIUM ACETATE

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

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 acetate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00018135 ↗	Parathyroid Hormone Levels in Relation to the Phosphorus Content of Meals	Completed	National Center for Research Resources (NCRR)	N/A	1969-12-31	Patients on hemodialysis tend to have chronic elevations in the level of phosphorus in the blood and a secondary increase in the iPTH level. This chronic elevation in iPTH can have adverse consequences, thus a variety of phosphate binders are given in an attempt to decrease the absorption of phosphorus present in the normal diet. Some preliminary studies have indicated that the iPTH level may change based on the amount of phosphorus present in a meal prior to any significant absorption of phosphorus. If this is true in hemodialysis patients, then the timing of the administration of phosphate binders in relation to the ingestion of meals needs to be considered
NCT00114114 ↗	Dose-Response of Gonadal Steroids and Bone Turnover in Older Men	Completed	AbbVie	N/A	2004-09-01	The purpose of this study is to determine the levels of testosterone and/or estradiol at which changes in bone turnover, body composition, strength, sexual function etc. begin to occur in older men. This information may help determine when to intervene with hormone replacement therapy in aging men.
NCT00114114 ↗	Dose-Response of Gonadal Steroids and Bone Turnover in Older Men	Completed	AstraZeneca	N/A	2004-09-01	The purpose of this study is to determine the levels of testosterone and/or estradiol at which changes in bone turnover, body composition, strength, sexual function etc. begin to occur in older men. This information may help determine when to intervene with hormone replacement therapy in aging men.

Clinical Trial Conditions for calcium acetate

Condition Name

Condition Name for calcium acetate
Intervention	Trials
Hyperphosphatemia	8
Chronic Kidney Disease	5
Healthy Volunteers	2

Condition MeSH

Condition MeSH for calcium acetate
Intervention	Trials
Kidney Diseases	12
Renal Insufficiency, Chronic	10
Hyperphosphatemia	9

Clinical Trial Locations for calcium acetate

Trials by Country

Trials by Country for calcium acetate
Location	Trials
United States	63
China	4
Italy	2
United Kingdom	2
France	2

Trials by US State

Trials by US State for calcium acetate
Location	Trials
New York	5
Texas	5
Pennsylvania	4
Ohio	3
Michigan	3

Clinical Trial Progress for calcium acetate

Clinical Trial Phase

Clinical Trial Phase for calcium acetate
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	1
Phase 4	11

Clinical Trial Status

Clinical Trial Status for calcium acetate
Clinical Trial Phase	Trials
Completed	29
Unknown status	5
Recruiting	4

Clinical Trial Sponsors for calcium acetate

Sponsor Name

Sponsor Name for calcium acetate
Sponsor	Trials
Shire	4
Fresenius Medical Care North America	3
International Centre for Diarrhoeal Disease Research, Bangladesh	3

Sponsor Type

Sponsor Type for calcium acetate
Sponsor	Trials
Other	40
Industry	26
NIH	2

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

Last updated: February 19, 2026

What is the Current Status of Clinical Trials for Calcium Acetate?

Calcium acetate is an established oral phosphate binder used primarily in patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD). Existing formulations have long been approved for dialysis patients, but new formulations and indications are under investigation:

• Recent Clinical Trials:

  • No new large-scale Phase 3 trials for calcium acetate have been registered in the past two years.
  • Several Phase 2 studies focus on its use in managing mineral bone disorder (CKD-MBD).
  • Some trials explore its efficacy in pediatric populations and for hyperphosphatemia in non-CKD populations, though these are in early phases.

• Regulatory Status:

  • Calcium acetate is approved by the FDA for hyperphosphatemia in CKD.
  • No recent filings support new indications or formulations.

• Ongoing Trials:

  • ClinicalTrials.gov lists fewer than five active studies related to calcium acetate, emphasizing its market maturity rather than innovation.

How is Calcium Acetate Positioned in the Market?

Market Size and Distribution

• Global Market Value:

  • Estimated at approximately USD 250 million in 2022.
  • Predominantly used in dialysis-dependent CKD patients.

• Market Share:

  • Accounts for roughly 35% of phosphate binders globally.
  • Competes with sevelamer (both carbonate and hydrochloride) and lanthanum-based agents.

• Key Regions:

  • North America: Largest market, due to high dialysis prevalence and established prescribing habits.
  • Europe: Second-largest, with growing adoption in managed care settings.
  • Asia-Pacific: Fastest-growing segment, driven by increasing CKD prevalence and rising healthcare infrastructure.

Competitive Landscape

Company	Key Product	Market Share (%)	Notes
Fresenius Medical Care	Phoslyra (calcium acetate dry powder)	25	Leading provider in dialysis settings
Tricadc	Calcium Acetate Capsules	15	Focused on North American market
Other Manufacturers	Generic calcium acetate formulations	60	Widely used, lower pricing

Pricing and Reimbursement

• The average wholesale price (AWP) for calcium acetate capsules ranges from USD 0.50 to USD 1.20 per tablet, depending on formulation and region.

• Reimbursement policies favor phosphate binders in dialysis, with calcium acetate often served as first-line due to lower cost.

What are the Market Drivers and Barriers?

Drivers

• Rising CKD and ESRD prevalence driven by aging populations and diabetes.

• Confirmed efficacy and safety profile of calcium acetate in managing hyperphosphatemia.

• Cost advantages over non-calcium-based phosphate binders.

Barriers

• Concerns over hypercalcemia with calcium-based binders.

• Regulatory challenges in expanding indications.

• Limited innovation leading to slow growth prospects.

What is the Market Projection for Calcium Acetate?

Short-term Outlook (Next 2 Years)

• Market growth is expected to be marginal at 2-3% annually, driven by expanding dialysis populations in emerging markets.

• Limited pipeline activity suggests no imminent significant market expansion or drug approvals.

Mid- to Long-term Outlook (Next 5 Years)

• Growth could stagnate due to replacement by newer, non-calcium phosphate binders such as sevelamer carbonate and ferric citrate.

• However, market share retention may persist due to cost advantages and established use.

• Potential for growth if new formulations demonstrate reduced calcium absorption or improved tolerability.

Innovations and Future Opportunities

• Development of combination therapies integrating phosphate binding with other CKD-related treatments.

• Formulation advances reducing pill burden can improve compliance and support market retention.

• None of these innovations are currently in advanced clinical development stages.

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Key Takeaways

• Calcium acetate remains a cornerstone in phosphate management for CKD patients but faces limited innovation.

• The market is mature, with minor growth driven mostly by demographic factors.

• Competition from non-calcium binders and potential safety concerns over hypercalcemia limit expansion.

• Investment in new formulations or indications would require significant clinical trial activity, which is currently absent.

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FAQs

1. Are there any recent approvals for new uses of calcium acetate?
No, regulatory agencies have not approved new indications beyond hyperphosphatemia management in CKD.

2. Can calcium acetate be used in non-CKD populations?
Limited clinical data exists; current approvals are specific to CKD-related hyperphosphatemia.

3. What are alternatives to calcium acetate in managing phosphate?
Sevelamer carbonate, lanthanum carbonate, ferric citrate, and aluminum-based binders (less common now).

4. Does calcium acetate pose significant safety risks?
It can cause hypercalcemia if used long-term or in high doses, especially in patients with high calcium intake.

5. Is the market for calcium acetate expected to grow significantly?
No, current trends suggest stable or marginal growth unless innovation or new indications emerge.

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References

1. ClinicalTrials.gov. (2023). Calcium acetate trials. https://clinicaltrials.gov
2. MarketsandMarkets. (2022). Phosphate Binders Market. https://marketsandmarkets.com
3. Food and Drug Administration. (2022). Calcium Acetate approvals. https://fda.gov
4. Grand View Research. (2022). CKD treatment market analysis. https://grandviewresearch.com
5. Sharma, S. et al. (2021). Trends in CKD treatment. Journal of Renal Care, 47(3), 134-142.