CLINICAL TRIALS PROFILE FOR ZINC SULFATE

505(b)(2) Clinical Trials for ZINC SULFATE

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 Dosage	NCT00266786 ↗	Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery	Completed	Egalet Ltd	Phase 3	2005-12-01	Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety. Previous studies with the nasal spray have suggested that it is similar to the previously approved injectable form in effectiveness for pain relief and in its safety profile. Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, subjects will receive study drug every 6 hours for 48 hours, and then as needed (up to 4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug, subjects will be given morphine sulfate or other standard analgesics. Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing. Subjects will be asked to answer questions about their pain relief and any possible side effects of the drug during the study, and will be given physical examinations, including nasal evaluations, before and during the clinical trial. A small amount of blood will be drawn for routine clinical laboratory testing.
New Dosage	NCT00266786 ↗	Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery	Completed	Luitpold Pharmaceuticals	Phase 3	2005-12-01	Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety. Previous studies with the nasal spray have suggested that it is similar to the previously approved injectable form in effectiveness for pain relief and in its safety profile. Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, subjects will receive study drug every 6 hours for 48 hours, and then as needed (up to 4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug, subjects will be given morphine sulfate or other standard analgesics. Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing. Subjects will be asked to answer questions about their pain relief and any possible side effects of the drug during the study, and will be given physical examinations, including nasal evaluations, before and during the clinical trial. A small amount of blood will be drawn for routine clinical laboratory testing.
OTC	NCT01067547 ↗	A Trial of Iron Replacement in Patients With Iron Deficiency.	Completed	Richard Fedorak	Phase 4	2010-03-01	Primary Hypothesis: There is no difference in the efficacy of iron replacement by oral or intravenous route in Inflammatory Bowel Disease patients. Iron deficiency anaemia is a common problem in people with inflammatory bowel disease (IBD) and patients with excessive blood loss from the bowel or heavy menstrual loss. Treatment options include a blood transfusion, oral iron with (Ferrograd ®) or intravenous iron replacement with iron sucrose (Venofer®). Iron deficiency anaemia is associated with poor quality of life, poor concentration span and low energy level. Blood transfusion may improve symptomatic anaemia quickly but there is a risk of transfusion reaction and blood born infection transmission. Moreover, packed cells are scarce resource therefore its use needs to be carefully prioritized. Oral iron supplement has been widely used and it can be purchased over the counter, however, its efficacy is not known in IBD population. Oral iron is poorly tolerated with side effects include altered bowel habit, nausea and darken stools, making it difficult to adhere to. In contrast, intravenous iron therapy with Venofer® has been shown to replenish iron store and improve anaemia quickly. To date, the safety of Venofer® use has been supported by its post marketing surveillance. Limitations with intravenous iron replacement include the need for medical supervision in the setting of limited healthcare resources; the need for patients to take multiple days off work and the cost of Venofer®. Currently it is uncertain which method of iron replacement is better. The purpose of this study is to compare the efficacy and the cost of oral and intravenous iron replacement in the setting of iron deficiency anaemia.
New Formulation	NCT01893905 ↗	Efficacy and Safety of a New Formulation of Chondroitin Sulfate and Glucosamine Sulfate to Treat Knee Osteoarthritis	Completed	Tedec-Meiji Farma, S.A.	Phase 3	2013-06-01	The main objective is to assess the efficacy of a new formulation containing chondroitin sulfate and glucosamine sulfate (CS+GS) compared with placebo in patients with primary osteoarthritis of the knee.

All Clinical Trials for ZINC SULFATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000304 ↗	Dextroamphetamine as an Adjunct in Cocaine Treatment - 1	Completed	University of Texas	Phase 2	1997-08-01	The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in cocaine treatment; an evaluation of the ""replacement"" strategy.
NCT00000304 ↗	Dextroamphetamine as an Adjunct in Cocaine Treatment - 1	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1997-08-01	The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in cocaine treatment; an evaluation of the ""replacement"" strategy.
NCT00000306 ↗	Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3	Completed	University of Texas	Phase 2	1994-09-01	The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in concurrent cocaine and opiate dependent patients.
NCT00000306 ↗	Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1994-09-01	The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in concurrent cocaine and opiate dependent patients.

Clinical Trial Conditions for ZINC SULFATE

Condition Name

Condition Name for ZINC SULFATE
Intervention	Trials
Pain	40
HIV Infections	35
Healthy	33
Postoperative Pain	32

Condition MeSH

Condition MeSH for ZINC SULFATE
Intervention	Trials
Lymphoma	84
Leukemia	60
Pain, Postoperative	57
Precursor Cell Lymphoblastic Leukemia-Lymphoma	56

Clinical Trial Locations for ZINC SULFATE

Trials by Country

Trials by Country for ZINC SULFATE
Location	Trials
United States	4,131
Canada	301
Egypt	128
Australia	94
China	71

Trials by US State

Trials by US State for ZINC SULFATE
Location	Trials
California	191
New York	169
Texas	169
Pennsylvania	142
Ohio	141

Clinical Trial Progress for ZINC SULFATE

Clinical Trial Phase

Clinical Trial Phase for ZINC SULFATE
Clinical Trial Phase	Trials
PHASE4	29
PHASE3	26
PHASE2	23

Clinical Trial Status

Clinical Trial Status for ZINC SULFATE
Clinical Trial Phase	Trials
Completed	552
RECRUITING	205
Unknown status	111

Clinical Trial Sponsors for ZINC SULFATE

Sponsor Name

Sponsor Name for ZINC SULFATE
Sponsor	Trials
National Cancer Institute (NCI)	163
Assiut University	50
Ain Shams University	27

Sponsor Type

Sponsor Type for ZINC SULFATE
Sponsor	Trials
Other	1213
Industry	413
NIH	206

Zinc Sulfate: Clinical Trial Landscape and Market Projections

Last updated: February 19, 2026

Zinc sulfate is a compound with established medical uses, primarily as a dietary supplement for treating zinc deficiency. Its application extends to various therapeutic areas, including ocular health, wound healing, and management of certain dermatological conditions. This report details current clinical trial activity, analyzes the existing market, and projects future market performance for zinc sulfate.

What is the Current Status of Zinc Sulfate Clinical Trials?

Clinical trial activity for zinc sulfate is segmented across multiple therapeutic areas, with a notable focus on established and potential new applications.

Ocular Health Trials

Zinc plays a crucial role in retinal function and is a component of several ocular enzymes. Clinical trials are investigating zinc sulfate's efficacy in preventing or slowing the progression of age-related macular degeneration (AMD) and other eye conditions.

• Age-Related Macular Degeneration (AMD):
  • The Age-Related Eye Disease Studies (AREDS and AREDS2) demonstrated that a combination of antioxidants and zinc sulfate can slow the progression of moderate to advanced AMD. The AREDS2 formulation includes lutein and zeaxanthin, with reduced copper. (Source: National Eye Institute)
  • Ongoing research continues to evaluate specific dosages and combinations, including the role of zinc sulfate as a monotherapy or in novel formulations for early and intermediate AMD.
• Dry Eye Disease:
  • Zinc sulfate has been explored for its potential anti-inflammatory properties and its role in tear film stability.
  • Some topical ophthalmic solutions containing zinc sulfate are available over-the-counter for symptomatic relief of dry eyes. Clinical trials are assessing their long-term efficacy and mechanisms of action.
• Other Ocular Conditions:
  • Limited trials have explored zinc sulfate in conditions like blepharitis and conjunctivitis, often focusing on its antiseptic and anti-inflammatory effects.

Dermatological Applications

Zinc sulfate's astringent, antiseptic, and anti-inflammatory properties make it a candidate for various skin conditions.

• Acne Vulgaris:
  • Both oral and topical zinc sulfate have been studied for acne treatment. Oral zinc sulfate is believed to reduce inflammation and inhibit bacterial growth.
  • Topical formulations are investigated for their ability to reduce sebum production and inflammatory lesions. Studies compare its efficacy against antibiotics and other standard acne treatments.
• Wound Healing:
  • Zinc is essential for cell proliferation, collagen synthesis, and immune function, all critical for wound repair.
  • Clinical trials examine the impact of oral zinc sulfate supplementation and topical zinc oxide (derived from zinc sulfate) on wound healing rates in various settings, including surgical wounds, pressure ulcers, and chronic ulcers.
• Dermatitis:
  • Zinc sulfate is evaluated for its use in diaper rash creams and other forms of irritant contact dermatitis, leveraging its barrier-forming and soothing properties.

Other Investigational Areas

• Infectious Diseases:
  • Research has investigated zinc sulfate's potential role in augmenting immune responses and its direct antimicrobial effects against certain pathogens.
  • Trials, particularly in resource-limited settings, have explored zinc supplementation for reducing the severity and duration of diarrheal diseases in children and for preventing respiratory infections.
• Neurological and Psychiatric Conditions:
  • Emerging research explores zinc's involvement in neurotransmission and neuroprotection.
  • Preliminary studies are examining zinc sulfate in conditions such as depression and Alzheimer's disease, though these are in early phases of investigation.

Table 1: Overview of Zinc Sulfate Clinical Trial Focus Areas

Therapeutic Area	Key Investigated Conditions	Primary Mechanism of Action Under Study	Stage of Investigation
Ocular Health	Age-Related Macular Degeneration (AMD), Dry Eye Disease	Antioxidant, anti-inflammatory, tear film stabilization, enzymatic cofactor	Phase II, Phase III, Post-marketing surveillance
Dermatology	Acne Vulgaris, Wound Healing, Dermatitis	Anti-inflammatory, astringent, antimicrobial, collagen synthesis support, cell proliferation	Phase II, Phase III, Observational studies
Infectious Diseases	Diarrheal Diseases, Respiratory Infections	Immune system modulation, antimicrobial activity	Phase III, Observational studies
Neurology/Psychiatry	Depression, Alzheimer's Disease	Neurotransmitter modulation, neuroprotection, antioxidant	Pre-clinical, Phase I/II (limited)
Nutritional Supplementation	Zinc Deficiency	Essential mineral cofactor for numerous enzymes	Established Use (Clinical trials focus on specific populations)

What is the Current Market for Zinc Sulfate?

The market for zinc sulfate is mature, driven by its established use as a mineral supplement and its incorporation into a wide range of pharmaceutical and dermatological products. Key market segments include pharmaceuticals, dietary supplements, cosmetics, and agriculture.

Market Segmentation and Key Drivers

• Pharmaceuticals: This segment is driven by prescription and over-the-counter (OTC) products for treating zinc deficiency, ophthalmic conditions, and certain skin disorders. The demand is influenced by healthcare access, disease prevalence, and physician recommendations.
• Dietary Supplements: This is a significant segment, fueled by consumer awareness of zinc's health benefits, including immune support and overall well-being. The growth is linked to health and wellness trends, aging populations, and preventative healthcare.
• Cosmetics and Personal Care: Zinc sulfate is used in skincare products (e.g., acne treatments, anti-dandruff shampoos) for its astringent and antiseptic properties.
• Agriculture: Zinc sulfate is a common micronutrient fertilizer, crucial for plant growth and crop yield. This segment is driven by agricultural practices, crop demand, and global food production needs.

Major Market Players

The market is characterized by a mix of large chemical manufacturers and specialized pharmaceutical companies. Key players include:

• Merck KGaA
• BASF SE
• American Elements
• Umicore
• Zochem
• Caldic B.V.
• Loba Chemie Pvt. Ltd.
• Sakthi Chemicals

These companies produce zinc sulfate in various grades (pharmaceutical, technical, food) to cater to diverse industry requirements.

Pricing and Availability

Zinc sulfate is generally available in bulk quantities at competitive prices. The price is subject to fluctuations in raw material costs (zinc metal, sulfuric acid) and global supply-demand dynamics. Pharmaceutical-grade zinc sulfate commands a premium due to stringent purity and quality control standards.

Regulatory Landscape

The regulatory framework for zinc sulfate varies by application.

• Pharmaceuticals: Subject to strict Good Manufacturing Practice (GMP) standards and approval processes by regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
• Dietary Supplements: Regulated as food products in many regions, with labeling and safety standards.
• Agriculture: Subject to regulations concerning fertilizer composition and environmental impact.

What are the Market Projections for Zinc Sulfate?

The global market for zinc sulfate is projected to experience steady growth, driven by increasing demand across its primary application sectors, particularly in healthcare and dietary supplements.

Projected Market Growth Rate

The global zinc sulfate market is expected to grow at a Compound Annual Growth Rate (CAGR) of approximately 3.5% to 4.5% over the next five to seven years. This growth is underpinned by several factors:

• Increasing Prevalence of Deficiency Diseases: Rising awareness and diagnosis of zinc deficiency, particularly in developing economies, will boost demand for supplementation.
• Aging Global Population: The growing elderly population is a key demographic for products aimed at supporting immune function, cognitive health, and eye health, areas where zinc plays a role.
• Expanding Applications in Pharmaceuticals and Healthcare: Continued research and development leading to new therapeutic indications or improved formulations for existing conditions will drive pharmaceutical segment growth.
• Growth in the Dietary Supplement Market: The ongoing trend towards self-care and preventative health measures is a significant driver for the dietary supplement sector.
• Agricultural Sector Demand: While more stable, the need for micronutrients in agriculture to enhance crop yields remains a consistent demand driver.

Factors Influencing Future Market Dynamics

• Technological Advancements: Innovations in purification techniques and formulation technologies could lead to higher-purity products and novel delivery systems, potentially opening new market niches.
• Emerging Markets: Growth in Asia-Pacific, Latin America, and Africa, driven by increasing healthcare expenditure, rising disposable incomes, and greater access to medicines and supplements, will be crucial.
• Competitive Landscape: The market is moderately competitive. Mergers, acquisitions, and strategic partnerships may occur to enhance market share and product portfolios.
• Raw Material Price Volatility: Fluctuations in the prices of zinc and sulfuric acid will continue to impact production costs and, consequently, market pricing.
• Regulatory Changes: Stricter regulations on product quality, safety, and environmental impact could influence market entry and operational costs for manufacturers.
• Clinical Trial Successes: Positive outcomes from ongoing clinical trials, especially in areas like advanced ophthalmology or novel dermatological treatments, could significantly boost demand for pharmaceutical-grade zinc sulfate. For instance, if trials confirm significant benefits of zinc sulfate in slowing cognitive decline, this could open a substantial new market segment.

Table 2: Global Zinc Sulfate Market Projection (Estimated)

Metric	Current Value (e.g., 2023)	Projected Value (e.g., 2030)	CAGR (2023-2030)	Key Drivers
Market Size (USD Billion)	$X.X$	$Y.Y$	3.5% - 4.5%	Healthcare demand, supplement market growth, agricultural needs
Pharmaceutical Segment Growth	Stable to Moderate	Moderate	N/A	New indications, OTC product demand
Dietary Supplement Segment	Strong	Stronger	N/A	Consumer awareness, aging population, wellness trends
Agricultural Segment	Stable	Stable	N/A	Crop production needs, soil micronutrient deficiency
Regional Growth (Dominant)	North America, Europe	Asia-Pacific, Emerging	N/A	Economic development, increased healthcare access, population growth in Asia-Pac

Note: Specific market size figures (X.X and Y.Y) are excluded as they require proprietary market research data. The CAGR range provides a directional projection based on industry trends.

Opportunities and Challenges

Opportunities:

• Investigational Therapies: Successful development of zinc sulfate-based treatments for chronic diseases like Alzheimer's or advanced stages of AMD could create significant new revenue streams.
• Personalized Nutrition: As the understanding of individual micronutrient needs grows, zinc sulfate could see increased use in personalized supplement formulations.
• Combination Therapies: Research into synergistic effects of zinc sulfate with other therapeutic agents may lead to new combination products.

Challenges:

• Generic Competition: For established indications like zinc deficiency, the market is saturated with generic and low-cost alternatives.
• Regulatory Hurdles: Obtaining new therapeutic indications requires extensive and costly clinical trials and regulatory approvals.
• Raw Material Price Volatility: Dependence on global commodity prices for zinc poses a risk to profit margins.
• Competition from Alternative Supplements: Other minerals and vitamins are also marketed for similar health benefits, creating a competitive environment in the supplement space.

Key Takeaways

• Zinc sulfate is utilized across multiple clinical domains, with ongoing trials in ophthalmology, dermatology, and infectious diseases seeking to expand its therapeutic applications.
• The market is mature, with the dietary supplement and pharmaceutical sectors being key demand drivers, influenced by health awareness and an aging population.
• Projected market growth of 3.5% to 4.5% CAGR is anticipated, fueled by expanding healthcare needs in emerging markets and continuous demand from established sectors.
• Future opportunities lie in the successful development of novel therapeutic indications, while challenges include raw material price volatility and regulatory compliance.

Frequently Asked Questions

1. What are the primary routes of administration for zinc sulfate in clinical trials? Clinical trials investigate both oral (tablets, capsules, solutions) and topical (creams, ointments, ophthalmic solutions) routes of administration, depending on the targeted condition. Intravenous administration is typically reserved for severe deficiency cases under strict medical supervision.

2. Which geographical regions are expected to experience the highest growth in zinc sulfate consumption? The Asia-Pacific region is projected to lead growth due to its large population, increasing healthcare expenditure, rising disposable incomes, and growing awareness of health and wellness. Emerging markets in Latin America and Africa are also expected to contribute significantly.

3. How do regulatory approvals impact the market for zinc sulfate? Regulatory approvals are critical for pharmaceutical applications, dictating efficacy and safety standards, and influencing market access and pricing. For dietary supplements, regulations focus on labeling, purity, and general safety, while agricultural use is governed by fertilizer and environmental standards.

4. What is the impact of raw material price fluctuations on zinc sulfate manufacturers? The price of zinc metal and sulfuric acid directly influences the production cost of zinc sulfate. Significant volatility in these commodity markets can lead to unpredictable profit margins and affect the final pricing of zinc sulfate products.

5. Beyond therapeutic uses, what are other significant market segments for zinc sulfate? Besides pharmaceuticals and dietary supplements, significant market segments include agriculture, where it's used as a micronutrient fertilizer to improve crop yields, and the cosmetics and personal care industry, where its astringent and antiseptic properties are leveraged in skincare and hair products.

Citations

[1] National Eye Institute. (n.d.). Age-Related Eye Disease Studies (AREDS and AREDS2). Retrieved from [Website of National Eye Institute] (Note: Specific URL for AREDS/AREDS2 overview is typically found on their official site)