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Last Updated: January 6, 2025

CLINICAL TRIALS PROFILE FOR CALCIUM GLUCONATE IN SODIUM CHLORIDE


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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 - <18 months = 175 children Stratum 2: 18 months - 59 months = 175 children Objectives: 1. Primary Objective: Acceptability of the zinc product in the management of childhood diarrhea will be assessed by observing: i) Incidence of vomiting or regurgitation among enrolled children receiving the improvised zinc formulation. ii) The adherence: The number of days (out of the total 10 days) the child took the protocol-prescribed dose of the medicine. The treatment will be considered to have good acceptability if at least 80% of the prescribed treatment is taken by at least 70% of the children over the duration of 10 days, as per WHO guidelines. 2. Secondary objective : To assess palatability Secondary end point evaluation (Palatability): The statistical analysis will comprise the calculation of the percentage of patients out of 350 who found the investigational product to have "very well-tolerated, well-tolerated or tolerated" scores (i.e. any of the upper 3 possible scores). A 95% confidence interval, using the normal approximation of the binomial distribution, will be calculated for the percentage.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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.
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for calcium gluconate in sodium chloride

Condition Name

Condition Name for calcium gluconate in sodium chloride
Intervention Trials
Osteoporosis 4
Neuropathy 2
Neurotoxicity 2
Colorectal Cancer 2
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Condition MeSH

Condition MeSH for calcium gluconate in sodium chloride
Intervention Trials
Osteoporosis 4
Breast Neoplasms 3
Ovarian Hyperstimulation Syndrome 3
Atrial Fibrillation 2
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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 79
Canada 12
Egypt 4
Mexico 2
Malaysia 1
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Trials by US State

Trials by US State for calcium gluconate in sodium chloride
Location Trials
Minnesota 4
Illinois 4
New York 3
Wisconsin 3
Georgia 3
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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
Phase 4 5
Phase 3 10
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for calcium gluconate in sodium chloride
Clinical Trial Phase Trials
Completed 18
Recruiting 5
Not yet recruiting 4
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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
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Sponsor Type

Sponsor Type for calcium gluconate in sodium chloride
Sponsor Trials
Other 40
NIH 7
Industry 2
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Calcium gluconate in sodium chloride Market Analysis and Financial Projection

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

Introduction

Calcium gluconate in sodium chloride is a crucial medical formulation used to treat various calcium deficiency conditions. This article delves into the current state of clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Ongoing and Recent Trials

Several clinical trials are ongoing or have recently been completed to evaluate the efficacy and safety of calcium gluconate in sodium chloride. Here are some notable examples:

  • Phase 2 and Phase 4 Trials: Clinical trials sponsored by institutions such as Ascension Genesys Hospital and Aurora Health Care are in various phases. For instance, Ascension Genesys Hospital is conducting a Phase 2 trial, while Aurora Health Care is involved in a Phase 4 trial[1].
  • Global Participation: Trials are also being conducted in other regions, such as the First Affiliated Hospital of Xi'an Jiaotong University, highlighting the global interest in this medication[1].

Key Focus Areas

These trials focus on the treatment of acute symptomatic hypocalcemia in pediatric and adult patients, as well as other calcium deficiency-related conditions. The data from these trials will be crucial in further establishing the safety and efficacy profiles of calcium gluconate in sodium chloride.

Pharmacology and Mechanism of Action

Drug Class and Mechanism

Calcium gluconate in sodium chloride belongs to the class of blood coagulation factor phosphate binders. Its mechanism of action involves phosphate chelating activity, which leads to increased coagulation factor activity. This is particularly important in treating conditions such as hypocalcemia tetany, hypotension, and hypermagnesemia[1].

Formulation and Administration

The drug is often administered intravenously and is available in various concentrations, such as 1000 mg/50 mL and 2000 mg/100 mL. Sodium chloride is added as a tonicity agent to ensure the solution does not require further dilution before administration[4].

Market Analysis

Market Size and Growth

The global calcium gluconate market is experiencing robust growth. By 2025, the market size is estimated to reach $976 million, growing at a Compound Annual Growth Rate (CAGR) of 6.29% during the forecast period 2020-2025[2].

Segment Analysis

  • By Form: The market is segmented into gum, powder, and liquid forms. However, the pharmaceutical segment, which includes calcium gluconate in sodium chloride, has registered high revenue and is expected to continue growing due to the demand for health and essential medicines[2].
  • By End Use: The bulking agent segment is leading in terms of revenue, driven by high demand in the pharmaceutical and food industries. The food and beverages segment is also growing, with a CAGR of 5.87% during the forecast period[2].
  • By Geography: Asia Pacific holds a significant market share of 43%, with China and India being major consumption regions. The U.S. and South America are also poised to grow at a high CAGR due to innovative technologies and increasing demand[2].

Drivers of Market Growth

The market growth is driven by several factors, including:

  • Rising Demand: Increasing demand from pharmaceutical and food & beverages industries due to the benefits of calcium supplements in treating calcium deficiencies[2].
  • Health Awareness: Growing health consciousness and awareness about calcium deficiency are driving the demand for calcium gluconate products[5].
  • Regulatory Support: Supportive regulatory frameworks promoting the use of food additives and pharmaceuticals also contribute to market growth[5].

Challenges

Despite the growth, the market faces challenges such as:

  • Excessive Intake: The risk of excessive intake of calcium gluconate, which can lead to adverse effects, is a significant challenge[2].

Recent Approvals and Market Impact

FDA Approvals

Recent approvals have significant implications for the market:

  • Amneal Pharmaceuticals: Received FDA approval for calcium gluconate in sodium chloride injection in 2023, which includes a Competitive Generic Therapy (CGT) designation with 180-day exclusivity. This approval addresses the shortage of this essential medicine and reflects the company's commitment to meeting patient needs[3].
  • Fresenius Kabi: Previously approved in 2017, Fresenius Kabi's calcium gluconate injection has been a key player in the market, further solidifying the availability of this critical medication[1].

Projections and Future Outlook

Market Projections

The global calcium gluconate market is expected to continue its robust growth trajectory:

  • 2024-2033 Forecast: The market is projected to grow from $101.97 billion in 2023 to $150.62 billion by 2028, at a CAGR of 8.1%. This growth is fueled by an aging global population, increasing health awareness, and expansion in the food and beverage sector[5].
  • Emerging Markets: Urbanization and the emergence of new markets, particularly in Asia Pacific, will continue to drive growth. Digital marketing and e-commerce are also expected to play a significant role in promoting these products[5].

Key Players and Innovation

Key players in the market, such as Amneal Pharmaceuticals and Fresenius Kabi, are innovating and expanding their product lines to meet the growing demand. The focus on natural and organic products, as well as leveraging digital platforms, will be crucial in driving market innovation and growth.

"The approval of calcium gluconate injection, a key injectable in shortage, reflects our commitment to addressing immediate patient needs for essential medicines. This is part of our concerted strategy to address long-term shortages in the market." - Harsher Singh, Senior Vice President, Amneal Biosciences[3].

Key Takeaways

  • Clinical Trials: Ongoing trials are focusing on the treatment of acute symptomatic hypocalcemia and other calcium deficiency-related conditions.
  • Market Growth: The global calcium gluconate market is expected to grow significantly, driven by increasing demand from pharmaceutical and food & beverages industries.
  • Recent Approvals: FDA approvals for generic versions of calcium gluconate in sodium chloride are addressing market shortages and ensuring patient access to essential medicines.
  • Future Outlook: The market is projected to continue growing, fueled by health awareness, regulatory support, and emerging markets.

FAQs

What is the primary use of calcium gluconate in sodium chloride?

Calcium gluconate in sodium chloride is primarily used to treat acute symptomatic hypocalcemia in pediatric and adult patients, as well as other conditions arising from calcium deficiencies.

What are the key drivers of the calcium gluconate market growth?

The market growth is driven by increasing demand from pharmaceutical and food & beverages industries, growing health awareness, and supportive regulatory frameworks.

Which regions are leading in the consumption of calcium gluconate?

Asia Pacific, particularly China and India, holds a significant market share due to advanced production technology and high demand from end-use industries.

What are the potential risks associated with calcium gluconate intake?

Excessive intake of calcium gluconate can lead to adverse effects, which is a significant challenge for the market.

What recent FDA approvals have impacted the calcium gluconate market?

Amneal Pharmaceuticals received FDA approval for calcium gluconate in sodium chloride injection in 2023, addressing the shortage of this essential medicine and reflecting the company's commitment to meeting patient needs.

Sources

  1. Drug Patent Watch: "Calcium Gluconate in Sodium Chloride Drug Patent Profile"
  2. IndustryARC: "Calcium Gluconate Market - Forecast(2024 - 2030)"
  3. Amneal Pharmaceuticals: "Amneal Receives U.S. FDA Approval for Calcium Gluconate Injection"
  4. FDA: "210906Orig1s000 - accessdata.fda.gov"
  5. EIN Presswire: "Calcium Gluconate Market Size, Share, Revenue, Trends And Drivers For 2024-2033"

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