CLINICAL TRIALS PROFILE FOR ZINC CHLORIDE IN PLASTIC CONTAINER

505(b)(2) Clinical Trials for Zinc Chloride In Plastic Container

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 Combination	NCT00016744 ↗	Phenylbutyrate/Genistein Duotherapy in Delta F508-Homozygous(for Cystic Fibrosis)	Completed	Cystic Fibrosis Foundation	Phase 1/Phase 2	2001-09-01	We are testing a new combination of medicines, to determine if they could be used to treat cystic fibrosis (CF). Subjects with CF who have two copies of the most common mutation (change) found in patients with CF called DF508. CF is caused by a lack of chloride movement in the nose, sinuses, lungs, intestines, pancreas and sweat glands. We are conducting this study to determine the safety of using a combination of two medicines, Phenylbutyrate and Genistein, to improve the ability of the cells lining the nose to regulate movement of salt (chloride) and water in people with CF. Phenylbutyrate has been extensively used to treat patients with rare metabolic diseases (which are very different from CF), Phenylbutyrate is an investigational drug for the purpose of this study. Genistein is a naturally occurring substance that is found in food products such as soy and tofu, but is also an investigational drug for this study. Both drugs may be able to restore normal chloride movements in body organs and glands. We will be studying salt and water in the nose movement by a technique called nasal transepithelial potential difference (NPD).
New Combination	NCT00016744 ↗	Phenylbutyrate/Genistein Duotherapy in Delta F508-Homozygous(for Cystic Fibrosis)	Completed	Cystic Fibrosis Foundation Therapeutics	Phase 1/Phase 2	2001-09-01	We are testing a new combination of medicines, to determine if they could be used to treat cystic fibrosis (CF). Subjects with CF who have two copies of the most common mutation (change) found in patients with CF called DF508. CF is caused by a lack of chloride movement in the nose, sinuses, lungs, intestines, pancreas and sweat glands. We are conducting this study to determine the safety of using a combination of two medicines, Phenylbutyrate and Genistein, to improve the ability of the cells lining the nose to regulate movement of salt (chloride) and water in people with CF. Phenylbutyrate has been extensively used to treat patients with rare metabolic diseases (which are very different from CF), Phenylbutyrate is an investigational drug for the purpose of this study. Genistein is a naturally occurring substance that is found in food products such as soy and tofu, but is also an investigational drug for this study. Both drugs may be able to restore normal chloride movements in body organs and glands. We will be studying salt and water in the nose movement by a technique called nasal transepithelial potential difference (NPD).
New Combination	NCT00016744 ↗	Phenylbutyrate/Genistein Duotherapy in Delta F508-Homozygous(for Cystic Fibrosis)	Completed	National Center for Research Resources (NCRR)	Phase 1/Phase 2	2001-09-01	We are testing a new combination of medicines, to determine if they could be used to treat cystic fibrosis (CF). Subjects with CF who have two copies of the most common mutation (change) found in patients with CF called DF508. CF is caused by a lack of chloride movement in the nose, sinuses, lungs, intestines, pancreas and sweat glands. We are conducting this study to determine the safety of using a combination of two medicines, Phenylbutyrate and Genistein, to improve the ability of the cells lining the nose to regulate movement of salt (chloride) and water in people with CF. Phenylbutyrate has been extensively used to treat patients with rare metabolic diseases (which are very different from CF), Phenylbutyrate is an investigational drug for the purpose of this study. Genistein is a naturally occurring substance that is found in food products such as soy and tofu, but is also an investigational drug for this study. Both drugs may be able to restore normal chloride movements in body organs and glands. We will be studying salt and water in the nose movement by a technique called nasal transepithelial potential difference (NPD).
New Combination	NCT00016744 ↗	Phenylbutyrate/Genistein Duotherapy in Delta F508-Homozygous(for Cystic Fibrosis)	Completed	Children's Hospital of Philadelphia	Phase 1/Phase 2	2001-09-01	We are testing a new combination of medicines, to determine if they could be used to treat cystic fibrosis (CF). Subjects with CF who have two copies of the most common mutation (change) found in patients with CF called DF508. CF is caused by a lack of chloride movement in the nose, sinuses, lungs, intestines, pancreas and sweat glands. We are conducting this study to determine the safety of using a combination of two medicines, Phenylbutyrate and Genistein, to improve the ability of the cells lining the nose to regulate movement of salt (chloride) and water in people with CF. Phenylbutyrate has been extensively used to treat patients with rare metabolic diseases (which are very different from CF), Phenylbutyrate is an investigational drug for the purpose of this study. Genistein is a naturally occurring substance that is found in food products such as soy and tofu, but is also an investigational drug for this study. Both drugs may be able to restore normal chloride movements in body organs and glands. We will be studying salt and water in the nose movement by a technique called nasal transepithelial potential difference (NPD).
New Formulation	NCT00244777 ↗	Introduction of Hypo-osmolar ORS for Routine Use	Completed	United States Agency for International Development (USAID)	Phase 4	2002-12-01	The World Health Organization has very recently recommended the routine use of a hypo-osmolar ORS in the management of diarrhoeal diseases. This recommendation is based on the better efficacy of the hypo-osmolar ORS over the standard WHO ORS demonstrated in controlled clinical trials. The recommendation, however, also expressed the need for "careful monitoring to better assess risk, if any, of symptomatic hyponatraemia". There thus is a need for phase IV trials before the new solution is introduced into routine clinical practice to assess the risk in relatively large number of patient populations. The proposed study will be carried out at two different settings- at the urban settings of the Dhaka Hospital (60000 patients) and at the rural settings of the Matlab Hospital (15000 patients) of ICDDR,B. The hypo-osmolar rice or glucose-based ORS will be introduced as standard management of patients with diarrhoea . The hypo-osmolar ORS will contain 75 mmol /L of sodium instead of 90 mmol/L. Surveillance will be carried out to detect adverse events focusing on the occurrence of seizures or undue lethargy during hospitalization. Each episode of seizure or undue lethargy would be evaluated to determine if they are associated with abnormal levels of serum sodium or glucose, or fever. It has been estimated that about 3% (1,800) of patients initially admitted to the Short Stay Ward of the Dhaka Hospital, and 340 patients at the Matlab Hospital might require admission to the longer stay inpatient wards due to seizure or altered consciousness. Such patients would be thoroughly assessed including determination of their serum sodium and glucose, two common causes of seizures/altered consciousness, to determine if and to what extent they could be attributed to hyponatraemia.The results from this study would be used in planning and implementing the routine use of the new formulation of ORS at all Government, NGO and private health care facilities that treat diarrhoeal patients, in Bangladesh and in other countries.
New Formulation	NCT00244777 ↗	Introduction of Hypo-osmolar ORS for Routine Use	Completed	International Centre for Diarrhoeal Disease Research, Bangladesh	Phase 4	2002-12-01	The World Health Organization has very recently recommended the routine use of a hypo-osmolar ORS in the management of diarrhoeal diseases. This recommendation is based on the better efficacy of the hypo-osmolar ORS over the standard WHO ORS demonstrated in controlled clinical trials. The recommendation, however, also expressed the need for "careful monitoring to better assess risk, if any, of symptomatic hyponatraemia". There thus is a need for phase IV trials before the new solution is introduced into routine clinical practice to assess the risk in relatively large number of patient populations. The proposed study will be carried out at two different settings- at the urban settings of the Dhaka Hospital (60000 patients) and at the rural settings of the Matlab Hospital (15000 patients) of ICDDR,B. The hypo-osmolar rice or glucose-based ORS will be introduced as standard management of patients with diarrhoea . The hypo-osmolar ORS will contain 75 mmol /L of sodium instead of 90 mmol/L. Surveillance will be carried out to detect adverse events focusing on the occurrence of seizures or undue lethargy during hospitalization. Each episode of seizure or undue lethargy would be evaluated to determine if they are associated with abnormal levels of serum sodium or glucose, or fever. It has been estimated that about 3% (1,800) of patients initially admitted to the Short Stay Ward of the Dhaka Hospital, and 340 patients at the Matlab Hospital might require admission to the longer stay inpatient wards due to seizure or altered consciousness. Such patients would be thoroughly assessed including determination of their serum sodium and glucose, two common causes of seizures/altered consciousness, to determine if and to what extent they could be attributed to hyponatraemia.The results from this study would be used in planning and implementing the routine use of the new formulation of ORS at all Government, NGO and private health care facilities that treat diarrhoeal patients, in Bangladesh and in other countries.

All Clinical Trials for Zinc Chloride In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000522 ↗	Treatment of Mild Hypertension Study (TOMHS)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	1985-08-01	To compare the effects of nonpharmacologic therapy alone with those of one of five active drug regimens combined with non-pharmacologic therapy, for long- term management of patients with mild hypertension.
NCT00000522 ↗	Treatment of Mild Hypertension Study (TOMHS)	Completed	University of Minnesota	Phase 2	1985-08-01	To compare the effects of nonpharmacologic therapy alone with those of one of five active drug regimens combined with non-pharmacologic therapy, for long- term management of patients with mild hypertension.
NCT00000522 ↗	Treatment of Mild Hypertension Study (TOMHS)	Completed	University of Minnesota - Clinical and Translational Science Institute	Phase 2	1985-08-01	To compare the effects of nonpharmacologic therapy alone with those of one of five active drug regimens combined with non-pharmacologic therapy, for long- term management of patients with mild hypertension.
NCT00000822 ↗	A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals With Greater Than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells	Completed	Bristol-Myers Squibb	Phase 1	1969-12-31	To evaluate the safety and immunogenicity of HIV-1 MN rgp160 (Immuno-AG) in HIV-infected patients. To evaluate the immunogenicity of HIV-1 MN rgp160 immunogen by lymphocyte proliferation, specific antibody responses, and DTH reaction. To describe the durability of the immunogen in patients who respond to the first 7 injections when they are boosted every 8 weeks for an additional 6-12 months [AS PER AMENDMENT 11/12/96: stratum 1 patients only]. To describe the ability of the immunogen to induce a response after an additional 6-12 months of injections among patients who did not respond to the first 7 injections [AS PER AMENDMENT 11/12/96: stratum 1 patients only]. HIV-specific cellular immune responses appear to play an important role in HIV disease progression since both T helper and cytotoxic function against HIV decrease with disease progression.
NCT00000822 ↗	A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals With Greater Than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells	Completed	Immuno-US	Phase 1	1969-12-31	To evaluate the safety and immunogenicity of HIV-1 MN rgp160 (Immuno-AG) in HIV-infected patients. To evaluate the immunogenicity of HIV-1 MN rgp160 immunogen by lymphocyte proliferation, specific antibody responses, and DTH reaction. To describe the durability of the immunogen in patients who respond to the first 7 injections when they are boosted every 8 weeks for an additional 6-12 months [AS PER AMENDMENT 11/12/96: stratum 1 patients only]. To describe the ability of the immunogen to induce a response after an additional 6-12 months of injections among patients who did not respond to the first 7 injections [AS PER AMENDMENT 11/12/96: stratum 1 patients only]. HIV-specific cellular immune responses appear to play an important role in HIV disease progression since both T helper and cytotoxic function against HIV decrease with disease progression.
NCT00000822 ↗	A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals With Greater Than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To evaluate the safety and immunogenicity of HIV-1 MN rgp160 (Immuno-AG) in HIV-infected patients. To evaluate the immunogenicity of HIV-1 MN rgp160 immunogen by lymphocyte proliferation, specific antibody responses, and DTH reaction. To describe the durability of the immunogen in patients who respond to the first 7 injections when they are boosted every 8 weeks for an additional 6-12 months [AS PER AMENDMENT 11/12/96: stratum 1 patients only]. To describe the ability of the immunogen to induce a response after an additional 6-12 months of injections among patients who did not respond to the first 7 injections [AS PER AMENDMENT 11/12/96: stratum 1 patients only]. HIV-specific cellular immune responses appear to play an important role in HIV disease progression since both T helper and cytotoxic function against HIV decrease with disease progression.

Clinical Trial Conditions for Zinc Chloride In Plastic Container

Condition Name

Condition Name for Zinc Chloride In Plastic Container
Intervention	Trials
Cystic Fibrosis	49
Healthy	27
Pain	16
Hypertension	13

Condition MeSH

Condition MeSH for Zinc Chloride In Plastic Container
Intervention	Trials
Fibrosis	52
Cystic Fibrosis	50
Kidney Diseases	22
Hemorrhage	21

Clinical Trial Locations for Zinc Chloride In Plastic Container

Trials by Country

Trials by Country for Zinc Chloride In Plastic Container
Location	Trials
United States	810
China	71
Germany	49
Australia	49
Canada	41

Trials by US State

Trials by US State for Zinc Chloride In Plastic Container
Location	Trials
California	64
Texas	57
Illinois	36
Florida	35
North Carolina	35

Clinical Trial Progress for Zinc Chloride In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Zinc Chloride In Plastic Container
Clinical Trial Phase	Trials
Phase 4	195
Phase 3	134
Phase 2/Phase 3	28

Clinical Trial Status

Clinical Trial Status for Zinc Chloride In Plastic Container
Clinical Trial Phase	Trials
Completed	422
Recruiting	125
Unknown status	67

Clinical Trial Sponsors for Zinc Chloride In Plastic Container

Sponsor Name

Sponsor Name for Zinc Chloride In Plastic Container
Sponsor	Trials
National Heart, Lung, and Blood Institute (NHLBI)	13
Vertex Pharmaceuticals Incorporated	12
Allergan	12

Sponsor Type

Sponsor Type for Zinc Chloride In Plastic Container
Sponsor	Trials
Other	977
Industry	299
NIH	46

Zinc Chloride in Plastic Containers: Clinical, Market, and Projection Analysis

Introduction

Zinc chloride, a versatile chemical compound, is widely used in various industries, including pharmaceuticals, electronics, and construction. When packaged in plastic containers, particularly for medical use, it is crucial to understand its clinical implications, market dynamics, and future projections.

Clinical Pharmacology and Use

Zinc chloride, when used as a medical solution, is typically formulated as a sterile, nonpyrogenic injection intended for intravenous use, often as part of total parenteral nutrition. Each milliliter of the solution contains 1 mg of zinc, along with other components like sodium chloride, and may include hydrochloric acid and sodium hydroxide for pH adjustment[1].

Role in Human Health

Zinc is an essential nutrient that serves as a cofactor for over 70 enzymes, including those involved in wound healing, growth, and skin hydration. It is particularly critical in parenteral nutrition, especially for patients with impaired kidney function or premature neonates who require careful management of mineral intake[1].

Safety and Precautions

The use of zinc chloride injections must be carefully managed to avoid adverse reactions. Overdosage can lead to symptoms such as profuse sweating, decreased consciousness, blurred vision, tachycardia, and hypothermia. It is essential to use these solutions only if they are clear and the seal is intact, and to follow aseptic techniques in a laminar flow environment[1].

Market Analysis

Global Market Size and Growth

The global zinc chloride market is projected to experience significant growth. By 2023, the market size was valued at approximately USD 309.6 million and is expected to reach USD 505.6 million by 2033, growing at a CAGR of 5.0% during this period[2].

Key Drivers

Several sectors drive the demand for zinc chloride:

• Pharmaceuticals: Used in pharmaceutical formulations and as a disinfectant in medical settings.
• Electronics: Essential in the production of batteries, especially zinc-carbon batteries used in consumer electronics.
• Construction: Used for waterproofing and as a concrete additive.
• Agriculture: Serves as an essential micronutrient in fertilizers[2][3].

Regional Market Dynamics

• Asia-Pacific: Expected to grow at the fastest CAGR due to rapid industrialization and robust economic development in countries like China and India.
• Europe: Accounts for the second-largest market share, driven by stringent environmental regulations and a focus on sustainable practices.
• India: Holds immense growth potential with a projected CAGR of 7.4% over the forecast period[2][5].

Market Trends

Increasing Demand in Water Treatment

Zinc chloride is increasingly used as a flocculant and disinfectant in water treatment, driven by stricter environmental regulations and the need for effective water purification[3].

High Purity Segment

The high purity segment of zinc chloride is anticipated to dominate the market, expanding at a CAGR of 4.9% from 2023 to 2033 and creating a significant growth opportunity[2].

Renewable Energy and EV Applications

The demand for zinc chloride is surging due to its use in the manufacturing of solar cells and other energy storage devices, as well as in electric vehicle (EV) batteries. This trend is expected to continue as the automotive industry shifts towards sustainable transportation solutions[2][5].

Storage and Handling

For medical use, zinc chloride injections are supplied in single-dose plastic vials and must be stored at controlled room temperatures (20°C to 25°C or 68°F to 77°F). The plastic containers are made from a specially formulated polyolefin, ensuring safety and integrity of the solution[1][4].

Clinical Trials and Safety Data

While specific clinical trials on zinc chloride injections are not widely detailed, the safety profile is well-established. However, it is crucial to monitor patients for signs of toxicity, especially in cases of prolonged parenteral administration or in patients with impaired kidney function. Acute toxicity has been reported in cases of high doses, emphasizing the need for careful dosing and monitoring[1].

Future Projections

Market Growth

The zinc chloride market is expected to continue growing, driven by expanding applications in various sectors. The CAGR of 5.0% from 2023 to 2033 indicates a robust market with significant opportunities for growth[2].

Emerging Markets

India and China are expected to be key drivers of this growth, with India projected to experience a steady CAGR of 7.4% and China anticipated to create an absolute dollar opportunity of more than US$ 40 million by the end of the forecast period[2][5].

Key Takeaways

• Clinical Use: Zinc chloride is essential in parenteral nutrition and has various medical applications.
• Market Growth: The global market is projected to reach USD 505.6 million by 2033, growing at a CAGR of 5.0%.
• Key Drivers: Pharmaceuticals, electronics, construction, and agriculture sectors drive demand.
• Regional Dynamics: Asia-Pacific and Europe are significant markets, with India and China showing high growth potential.
• Storage and Handling: Must be stored at controlled room temperatures in specially formulated plastic containers.

FAQs

What is the primary use of zinc chloride in medical settings?

Zinc chloride is used as an additive to intravenous solutions for total parenteral nutrition and in various pharmaceutical formulations and medical settings as a disinfectant.

What are the key sectors driving the demand for zinc chloride?

The key sectors include pharmaceuticals, electronics, construction, and agriculture.

How is the global zinc chloride market expected to grow?

The global zinc chloride market is expected to grow at a CAGR of 5.0% from 2023 to 2033, reaching USD 505.6 million by 2033.

What are the storage requirements for zinc chloride injections?

Zinc chloride injections must be stored at controlled room temperatures (20°C to 25°C or 68°F to 77°F) in single-dose plastic vials.

What are the potential risks associated with zinc chloride injections?

Overdosage can lead to symptoms such as profuse sweating, decreased consciousness, blurred vision, tachycardia, and hypothermia, emphasizing the need for careful dosing and monitoring.

Sources

1. Accessdata.fda.gov: Zinc 1 mg/mL (Zinc Chloride Injection, USP) - Label.
2. Future Market Insights: Zinc Chloride Market Share, Trends & Forecast of 2033.
3. Data Bridge Market Research: Global Zinc Chloride Market Size, Report, Trends, & Forecast By 2031.
4. Pfizer Medical Information: Zinc Chloride Injection, USP - Storage and Handling.
5. Market Research Future: Zinc Chloride Market Analysis.