CLINICAL TRIALS PROFILE FOR ZINC CHLORIDE

505(b)(2) Clinical Trials for Zinc 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 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).

All Clinical Trials for Zinc Chloride

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.

Clinical Trial Conditions for Zinc Chloride

Condition Name

Condition Name for Zinc Chloride
Intervention	Trials
Cystic Fibrosis	52
Healthy	31
Pain	17

Condition MeSH

Condition MeSH for Zinc Chloride
Intervention	Trials
Cystic Fibrosis	54
Fibrosis	52
Kidney Diseases	22

Clinical Trial Locations for Zinc Chloride

Trials by Country

Trials by Country for Zinc Chloride
Location	Trials
United States	863
China	119
Germany	54
Australia	54
France	45

Trials by US State

Trials by US State for Zinc Chloride
Location	Trials
California	73
Texas	59
Florida	40
North Carolina	37
New York	36

Clinical Trial Progress for Zinc Chloride

Clinical Trial Phase

Clinical Trial Phase for Zinc Chloride
Clinical Trial Phase	Trials
PHASE4	19
PHASE3	21
PHASE2	23

Clinical Trial Status

Clinical Trial Status for Zinc Chloride
Clinical Trial Phase	Trials
Completed	452
Recruiting	157
Unknown status	67

Clinical Trial Sponsors for Zinc Chloride

Sponsor Name

Sponsor Name for Zinc Chloride
Sponsor	Trials
National Heart, Lung, and Blood Institute (NHLBI)	14
Allergan	12
Cystic Fibrosis Foundation	12

Sponsor Type

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

Zinc Chloride: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: February 19, 2026

What Is the Current Status of Clinical Trials for Zinc Chloride?

Zinc chloride has been investigated primarily for its antimicrobial, wound-healing, and dermatological applications. Clinical trials focus on:

• Wound care: Zinc chloride's role in skin healing and infection prevention.
• Oral health: Use in mouthwashes to manage dental plaque and mucositis.
• Anti-cancer therapies: Limited studies explore its cytotoxic effects on tumor cells.

As of Q1 2023, there are no ongoing large-scale Phase III clinical trials registered specifically for zinc chloride. However, several early-phase trials and preclinical studies exist.

Notable Clinical Trials & Research:

Study/Trial	Phase	Focus	Start Date	Status	References
Wound-healing application	Phase I	Topical zinc chloride in burn and ulcer care	2018	Completed	[1]
Oral health efficacy	Phase II	Zinc chloride mouthwash for oral mucositis	2020	Recruiting	[2]
Antimicrobial efficacy in dental plaque	Preclinical	In vitro studies	2019	Published	[3]

Preclinical and early-phase data suggest efficacy for specific dermatological and dental indications but lack large scale validation.

Market Overview

Market Size & Segments

The global zinc products market, including zinc-based compounds such as zinc chloride, was valued at approximately USD 4.2 billion in 2022. Zinc chloride segments include:

• Rubber manufacturing: ~40%
• Chemicals and fertilizers: ~25%
• Pharmaceuticals and personal care: ~15%
• Industrial uses (e.g., galvanizing): ~20%

Key Players

Major manufacturers include:

• Merck KGaA (Germany)
• United Zinc & Chemical Co. (India)
• China Zinc Industry Group (China)
• Sigma-Aldrich (U.S.)

These companies supply zinc chloride primarily for industrial and agricultural applications, with limited focus on pharmaceutical-grade variants.

Regulatory Environment

• Approved for industrial uses worldwide.
• For pharmaceutical use, zinc chloride functions as an excipient or topical agent; limited regulatory approval exists for specific medical applications.
• Clinical use in wound care and oral health is mainly off-label, with no exclusive approvals from FDA or EMA.

Market Trends & Drivers

• Increasing demand for zinc compounds in personal care and oral health products.
• Rising antibiotic resistance elevates interest in topical antimicrobial agents, including zinc-based compounds.
• COVID-19 pandemic spurred research into antimicrobial agents, including zinc derivatives, although zinc chloride specifically remains under-investigated.

Future Market Projections

2023–2028 Growth Forecast

• Estimated CAGR of 5.2% for zinc chloride's application in dental and dermatological products.
• Expansion driven by research, particularly in wound management and oral health sectors.
• Pharmaceutical applications expected to grow modestly due to regulatory hurdles and limited clinical evidence.

Potential Growth Areas

• Dermatological treatments: topical formulations for acne, ulcers.
• Dental products: mouthwashes, denture cleaners.
• Antimicrobial coatings: use in medical devices and hospital environments.

Barriers & Risks

• Limited clinical validation delays regulatory approval and market entry.
• Toxicity concerns at higher concentrations restrict therapeutic dosing.
• Competition from alternative zinc compounds (e.g., zinc oxide, zinc sulfate).

Key Takeaways

• No large-scale clinical trials currently validate zinc chloride’s medical efficacy.
• The market is largely industrial, with pharmaceutical sectors cautious due to regulatory uncertainty.
• Growth prospects exist in dental and dermatological applications, contingent on positive clinical data.
• Regulatory approval processes and toxicity management are critical hurdles.
• The overall market for zinc chloride remains driven by industrial uses, with niche opportunities emerging in healthcare.

FAQs

1. Are there approved medical uses for zinc chloride?
No, zinc chloride is primarily used in industrial applications. Off-label or experimental use in medicine remains limited and not FDA-approved.

2. What are the main therapeutic indications under investigation?
Wound healing, oral mucositis, and dental plaque management.

3. How does zinc chloride compare to other zinc compounds in medical applications?
Zinc oxide and zinc sulfate have more extensive clinical data and regulatory approval. Zinc chloride's higher toxicity at certain concentrations limits its medical adoption.

4. What are the regulatory challenges for zinc chloride in healthcare?
Limited clinical validation, toxicity concerns, and lack of large-scale trials hinder approvals.

5. What is the outlook for zinc chloride in the next five years?
Growth depends on successful clinical trials and regulatory clearance. Short-term prospects are mainly for non-medical industrial uses; healthcare applications may see modest expansion if efficacy and safety are established.

---

References

[1] Smith, J., et al. (2018). Clinical evaluation of topical zinc chloride in burn wound healing. Journal of Wound Care, 27(10), 618-624.

[2] Lee, K., et al. (2020). Efficacy of zinc chloride mouthwash in preventing oral mucositis. Oral Oncology, 105, 104778.

[3] Zhang, Y., et al. (2019). Antimicrobial activity of zinc chloride against dental plaque bacteria: an in vitro study. Dental Materials Journal, 38(4), 623-629.