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.
New Combination	NCT00590538 ↗	Phenylbutyrate/Genistein Duotherapy in Delta F508-Heterozygotes (for Cystic Fibrosis)	Terminated	Cystic Fibrosis Foundation	Phase 1/Phase 2	2003-02-01	The purpose of this research study is to test a new combination of medicines, Phenylbutyrate and Genistein, to determine if they could be used to treat cystic fibrosis (CF). The most common genetic mutation found in patients with CF is called Delta F508. Due to this mutation, there is a lack of salt (chloride) movement in your nose, sinuses, lungs, intestines, pancreas and sweat glands. This lack of movement causes the clinical manifestations of the disease. Although Phenylbutyrate has been extensively used to treat patients with rare metabolic diseases, 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. When used together, both drugs may be able to restore normal chloride and salt (water) movements in body organs and glands in people with CF. We will be studying salt and water movement in the nose by a technique called nasal transepithelial potential difference (NPD).

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.
NCT00001213 ↗	Cysteamine Eye Drops to Treat Corneal Crystals in Cystinosis	Completed	National Eye Institute (NEI)	Phase 2	1986-04-01	Cystinosis is an inherited disease that results in poor growth and kidney disease, among other things. The damage to the kidneys and other organs is thought to be due to accumulation of cystine inside the cells of various body tissues. This chemical also accumulates in the cornea-the covering of the eye over the pupil and iris. After 10 to 20 years, the corneas of some patients become so packed with crystals that the surfaces may become irregular, occasionally causing small, painful breaks. Patients enrolled in a NIH study on cystinosis are receiving the drug cysteamine. Taken by mouth, this drug reduces cystine in some tissues, but not in the cornea. This study began in 1986 to test whether cysteamine eye drops could prevent or reduce corneal cystine crystals in these patients. The drops have been very effective in removing crystals and reducing pain in patients who take the medication as directed. Patients who do not take the medication as prescribed do not benefit. After the effectiveness of the drops was proven, the main purpose was modified to continue to evaluate the long-term safety and effectiveness of cysteamine eye drops for treating cystine crystals in the corneas of patients with cystinosis until the drops are approved by the Food and Drug Administration (FDA). When the New Drug Application (NDA) for the Sigma-Tau standard formulation is granted, this protocol will be terminated.

Clinical Trial Conditions for Zinc Chloride In Plastic Container

Condition Name

Condition Name for Zinc Chloride In Plastic Container
Intervention	Trials
Cystic Fibrosis	52
Healthy	31
Pain	17
Hypertension	14

Condition MeSH

Condition MeSH for Zinc Chloride In Plastic Container
Intervention	Trials
Cystic Fibrosis	54
Fibrosis	52
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	863
China	119
Germany	54
Australia	54
France	45

Trials by US State

Trials by US State for Zinc Chloride In Plastic Container
Location	Trials
California	73
Texas	59
Florida	40
North Carolina	37
Illinois	36

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
PHASE4	19
PHASE3	21
PHASE2	23

Clinical Trial Status

Clinical Trial Status for Zinc Chloride In Plastic Container
Clinical Trial Phase	Trials
Completed	452
Recruiting	157
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)	14
Vertex Pharmaceuticals Incorporated	12
Allergan	12

Sponsor Type

Sponsor Type for Zinc Chloride In Plastic Container
Sponsor	Trials
Other	1079
Industry	338
NIH	49

Clinical Trials Update, Market Analysis, and Projection: Zinc Chloride in Plastic Container

Last updated: April 26, 2026

What is “zinc chloride in plastic container” in commercial terms?

“Zinc chloride in plastic container” is best treated as a packaged zinc chloride product rather than a single branded drug candidate. Zinc chloride is an established chemical used across multiple end markets (notably industrial and consumer formulations). In drug-development terms, there is no single, globally recognized “zinc chloride in plastic container” asset with a standard INN/USAN label that maps cleanly to a clinical-stage pipeline.

As a result, the only defensible market projection approach at a “product-in-container” level is to treat it as a packaging/merchandising configuration of a widely available chemical, where clinical trials are generally not applicable unless the product is positioned as a drug/therapeutic with a defined regulatory dossier.

No market-grade clinical program identifiers (sponsor, NCT/CTIS, investigational form, therapeutic indication, dosage, endpoint package) can be reliably mapped to the phrase “ZINC CHLORIDE IN PLASTIC CONTAINER” as a clinical trial subject.

Are there clinical trials specifically for “zinc chloride in plastic container”?

None can be confirmed from the information provided. A “container material” designation alone does not uniquely define an investigational medicinal product in clinical trial registries. For clinical-trials updates to be analyzable, the record must specify at least: active moiety (zinc chloride), dosage form, strength, route, indication, manufacturer/sponsor, and the exact investigational product.

Because “plastic container” is a packaging attribute, not an investigational therapeutic specification, it does not support a registry-level linkage to a unique clinical trial program.

Clinical-trials registry coverage logic (what would need to exist to prove an update)

To report a clinical-trials update with actionable signal, each trial record would need unambiguous matching to:

• Active: zinc chloride
• Therapeutic claim: drug indication and therapeutic route
• Investigational product definition: formulation and packaging listed consistently as “plastic container” (or equivalent)
• Unique identifiers: NCT number (US), CTIS ID (EU), EudraCT number (EU), or publication trial metadata

No such identifiers are available in the request text.

Why does this packaging-level description block a standard pipeline view?

A packaging change (plastic vs glass, liner type, grade of polymer, closure system) can matter for chemical stability, leachables, and bioavailability if the product is a medicinal liquid or topical intended for administration. But even when packaging impacts stability, clinical programs are typically tied to:

• the drug product (strength, excipients, route, dosing),
• the regulatory submission (MAA/NDA/ANDA),
• and the stability/bracketing strategy (often chemistry and regulatory studies, not therapeutic clinical endpoints).

Without an indication and product identity, “zinc chloride in plastic container” cannot be placed into a standard “clinical trial phase” waterfall.

What is the market? Segmenting zinc chloride by end-use, then mapping container relevance

At a decision-grade level, zinc chloride market sizing is normally done by end-use:

Segment (typical)	Zinc chloride role	Container relevance
Industrial chemicals	feedstock and intermediate	packaging affects corrosion/compatibility and bulk handling
Consumer/household formulations (region-specific)	formulation ingredient	container affects shelf stability and dispensing
Specialty applications	treated polymers, catalysts, cleaning/etching types	container affects stability and contamination control

A “plastic container” configuration can be a cost and distribution lever (weight, break resistance, supply chain scale), but it is not a unique market by itself unless the product is regulated as a drug and claims therapeutic performance.

Market analysis: the only projection path that is defensible from the given description

With no clinical pipeline and no defined therapeutic indication, projections for “zinc chloride in plastic container” should be treated as a packaging and supply-volume scenario, not a drug revenue forecast.

The two usable projection levers in this framing are:

1. Volume demand for zinc chloride in the relevant end markets (industrial + formulated products).
2. Share shift to plastic packaging driven by logistics, breakage resistance, and cost.

Projection structure (packaging-share model)

Revenue for packaged zinc chloride products generally scales as:

• Packaged units = (zinc chloride end-market volume) × (packaging share in plastic)
• Average selling price (ASP) = global chemical price adjusted by grades and formulation value
• Value = units × ASP

However, the request does not provide:

• a region,
• a grade (e.g., technical vs reagent vs pharmaceutical),
• a concentration/strength,
• pack sizes,
• target end use,
• or pricing basis.

Given the absence of those inputs, any numerical forecast would be speculative and not compliant with a hard-data patent-analysis standard.

What can be concluded on clinical risk and regulatory posture

Even though clinical trials are not confirmable from the request, there is a clear regulatory engineering reality for container changes:

• Packaging changes for medicinal products often trigger stability studies and regulatory updates.
• For a chemical product positioned outside drug use, packaging typically affects product quality and shelf life, not clinical efficacy.

But without confirmation that the product is regulated as a drug and without a defined dosage form, no regulator-grade pathway can be mapped.

Patent and regulatory landscape implications (for a “container” configuration)

Container-related changes can sometimes support intellectual property only when tied to:

• specific packaging material and structure (e.g., polymer type, liner composition, closure),
• a demonstrated technical effect (stability, reduced leachables, reduced degradation),
• and a defined product (concentration, excipients, route).

If “plastic container” is merely descriptive and not tied to a specific technical solution, it is unlikely to represent a stand-alone patentable inventive concept in many jurisdictions. For drug product stability innovations, patents often focus on:

• composition,
• manufacturing,
• packaging system construction,
• and stability outcomes.

No patent identifiers, assignee names, application numbers, or claim language are provided in the request, so no defensible patent mapping can be performed.

---

Key Takeaways

• “Zinc chloride in plastic container” reads as a packaged chemical product descriptor, not a defined investigational drug asset.
• A clinical trials update cannot be produced without trial identifiers or an indication-level drug product definition; none is present.
• A drug market projection is not supportable from the provided text because there is no indication, dosage form, strength, regulatory status, region, or pricing basis.
• The only decision-grade approach is a packaged chemical value model using zinc chloride end-market volumes and plastic packaging share, but it requires data not provided in the request.
• Container IP is usually claimable only when tied to a specific technical packaging solution plus demonstrated effect; “plastic container” alone is not enough to map to patent coverage.

FAQs

1) Is “zinc chloride in plastic container” an identifiable drug candidate?
No. The description does not uniquely map to a specific investigational medicinal product, trial record, or therapeutic indication.

2) Can container material alone drive clinical trials?
Clinical endpoints generally require a drug product definition tied to indication, route, and dosing. Container changes more often trigger stability and quality work rather than new therapeutic trials.

3) How should market forecasting be done for this product description?
Use a packaged product value model based on zinc chloride end-use volumes and plastic packaging penetration, with ASP by grade and region. A drug-style indication forecast is not applicable without an indication and regulatory framing.

4) Does this description imply a patent opportunity?
Only if it is tied to a specific packaging construction and demonstrated technical effect within a defined product specification. “Plastic container” alone is not claim-ready.

5) What is the most likely data path for a defensible projection?
Identify the product’s regulatory status (chemical vs drug), then anchor to zinc chloride end-market sizing and packaging share, followed by pack-level pricing assumptions.

---

References

[1] Not provided.