CLINICAL TRIALS PROFILE FOR COPPER

505(b)(2) Clinical Trials for COPPER

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
OTC	NCT02519231 ↗	Copper IUD Treatment Observation Study	Completed	Cook County Hospital	Phase 4	2016-02-01	Studies indicate that bleeding irregularities and dysmenorrhea are common reasons for copper IUD method discontinuation. Some evidence suggests that non-steroidal anti-inflammatory medications (NSAIDs) can help improve bleeding during Cu-IUD use. However, these studies did not examine NSAID use with the TCu380A specifically, nor did they evaluate readily available NSAIDs such as over-the-counter naproxen. For this reason, the investigators propose a pilot trial in which new TCu380A users complaining of heavy or prolonged menstrual bleeding or spotting after 1 month of use are randomized to naproxen or placebo to be taken the first 7 days of menstruation for three consecutive cycles, and then observed for one cycle without treatment.
OTC	NCT02519231 ↗	Copper IUD Treatment Observation Study	Completed	Teva Pharmaceuticals USA	Phase 4	2016-02-01	Studies indicate that bleeding irregularities and dysmenorrhea are common reasons for copper IUD method discontinuation. Some evidence suggests that non-steroidal anti-inflammatory medications (NSAIDs) can help improve bleeding during Cu-IUD use. However, these studies did not examine NSAID use with the TCu380A specifically, nor did they evaluate readily available NSAIDs such as over-the-counter naproxen. For this reason, the investigators propose a pilot trial in which new TCu380A users complaining of heavy or prolonged menstrual bleeding or spotting after 1 month of use are randomized to naproxen or placebo to be taken the first 7 days of menstruation for three consecutive cycles, and then observed for one cycle without treatment.
OTC	NCT02519231 ↗	Copper IUD Treatment Observation Study	Completed	University of Washington	Phase 4	2016-02-01	Studies indicate that bleeding irregularities and dysmenorrhea are common reasons for copper IUD method discontinuation. Some evidence suggests that non-steroidal anti-inflammatory medications (NSAIDs) can help improve bleeding during Cu-IUD use. However, these studies did not examine NSAID use with the TCu380A specifically, nor did they evaluate readily available NSAIDs such as over-the-counter naproxen. For this reason, the investigators propose a pilot trial in which new TCu380A users complaining of heavy or prolonged menstrual bleeding or spotting after 1 month of use are randomized to naproxen or placebo to be taken the first 7 days of menstruation for three consecutive cycles, and then observed for one cycle without treatment.
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 -
OTC	NCT06016452 ↗	A Study of Chlorophyllin for the Management of Brain Radio-necrosis in Patients With Diffuse Glioma	Recruiting	Bhabha Atomic Research Centre (BARC)	Phase 2	2023-11-13	Diffuse gliomas are common tumors involving the brain. They are usually treated by surgery followed by radiation and chemotherapy. Radiotherapy is used for the treatment of brain tumors which causes damage to the tumor cells. However, radiotherapy can also affect the surrounding healthy cells in the brain, causing inflammation and swelling in the region, which is known as radio necrosis (RN). This is considered a late side effect of radiation and is seen in 10-25% of patients treated with radiation for brain tumors. Sometimes, radionecrosis can be detected on routine imaging during follow-up without new symptoms (asymptomaticRN). At the same time, in some patients, it can give rise to new symptoms like headaches, weakness, seizures,etc (symptomatic RN). The standard treatment of RN includes steroid medicines called dexamethasone, which is helpful in a proportion of patients. This is a prospective phase 2 study. This study is being conducted to investigate the ability of the drug Chlorophyllin in the treatment of radionecrosis. Chlorophyllin is a water-soluble compound obtained from the green plant pigment called chlorophyll. It has been shown to have anti-cancer, anti-bacterial, anti-viral, anti-inflammatory, and antioxidant properties. It is also used as an oral formulation and is an over-the-counter drug in various countries, and also as a food colouring agent. This is the first time chlorophyllin will be used in the setting of brain radionecrosis. Our primary aim of the study is to assess whether CHL will improve the clinical-radiological response rates. This study will be conducted on a population of 118 patients for a duration of 3 months. The total study duration is 2 years. The study is funded by Bhabha Atomic Research Centre (BARC).

All Clinical Trials for COPPER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001262 ↗	Copper Histidine Therapy for Menkes Diseases	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1/Phase 2	1990-06-01	Menkes Disease is a genetic disorder affecting the metabolism of copper. Patient with this disease are both physically and mentally retarded. Menkes disease is usually first detected in the first 2-3 months of life. Infant males born with the disease fail to thrive, experience hypothermia, have delayed development, and experience seizures. These infants also have characteristic physical features such as changes of their hair and face. Females may also have changes in hair and skin color, but rarely have significant medical problems. Appropriate treatment of Menkes Disease requires that the disease be diagnosed early and treatment started before irreversible brain damage occurs. The aim of treatment is to bypass the normal route of absorption of copper through the gastrointestinal tract. Copper must then be delivered to brain cells and be available for use by enzymes. Copper histidine is a copper replacement that can be injected directly into the body to avoid absorption through the gastrointestinal tract. However, studies have shown the genetic abnormalities causing Menkes disease cannot simply be corrected by copper replacement injections. The genetic abnormality causing Menkes disease can vary in its severity. Patients with a genetic abnormality that may still permit some production of the enzymes required to process copper may receive benefit from early treatment with copper replacement. However, patients with severe abnormalities of the genes responsible for copper metabolism may receive no benefit from copper replacement. The purpose of this study is to continue to evaluate the effects of early copper histidine in Menkes disease patients and to correlate specific molecular defects with responses to treatment.
NCT00003751 ↗	Penicillamine, Low Copper Diet, and Radiation Therapy in Treating Patients With Glioblastoma	Completed	National Cancer Institute (NCI)	Phase 2	1999-03-01	RATIONALE: Penicillamine may stop the growth of glioblastomas by stopping blood flow to the tumor. A diet low in copper may interfere with the growth of brain tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining these therapies may be effective in treating glioblastoma. PURPOSE: Phase II trial to study the effectiveness of penicillamine, a low copper diet, and radiation therapy in treating patients who have newly diagnosed glioblastoma.
NCT00003751 ↗	Penicillamine, Low Copper Diet, and Radiation Therapy in Treating Patients With Glioblastoma	Completed	Sidney Kimmel Comprehensive Cancer Center	Phase 2	1999-03-01	RATIONALE: Penicillamine may stop the growth of glioblastomas by stopping blood flow to the tumor. A diet low in copper may interfere with the growth of brain tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining these therapies may be effective in treating glioblastoma. PURPOSE: Phase II trial to study the effectiveness of penicillamine, a low copper diet, and radiation therapy in treating patients who have newly diagnosed glioblastoma.
NCT00003751 ↗	Penicillamine, Low Copper Diet, and Radiation Therapy in Treating Patients With Glioblastoma	Completed	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Phase 2	1999-03-01	RATIONALE: Penicillamine may stop the growth of glioblastomas by stopping blood flow to the tumor. A diet low in copper may interfere with the growth of brain tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining these therapies may be effective in treating glioblastoma. PURPOSE: Phase II trial to study the effectiveness of penicillamine, a low copper diet, and radiation therapy in treating patients who have newly diagnosed glioblastoma.
NCT00004338 ↗	Study of Zinc for Wilson Disease	Completed	University of Michigan	Phase 4	1993-10-01	OBJECTIVES: I. Establish the safety and efficacy of extended maintenance zinc therapy in 200 patients with Wilson disease. II. Establish further the role of zinc in the prophylactic treatment of presymptomatic patients by increasing the current cohort from 80 to at least 100 patients. III. Establish further the role of zinc therapy in pregnant patients with Wilson disease. IV. Establish further the role of zinc therapy in children with Wilson disease.

Clinical Trial Conditions for COPPER

Condition Name

Condition Name for COPPER
Intervention	Trials
Contraception	22
HIV	8
Wilson Disease	6
Prostate Cancer	6

Condition MeSH

Condition MeSH for COPPER
Intervention	Trials
Hepatolenticular Degeneration	7
Prostatic Neoplasms	7
Glioblastoma	7
Breast Neoplasms	7

Clinical Trial Locations for COPPER

Trials by Country

Trials by Country for COPPER
Location	Trials
United States	245
Egypt	14
India	7
United Kingdom	7
Canada	5

Trials by US State

Trials by US State for COPPER
Location	Trials
California	21
New York	18
Michigan	16
Texas	15
Pennsylvania	15

Clinical Trial Progress for COPPER

Clinical Trial Phase

Clinical Trial Phase for COPPER
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	3
PHASE2	1

Clinical Trial Status

Clinical Trial Status for COPPER
Clinical Trial Phase	Trials
Completed	84
Recruiting	33
Terminated	16

Clinical Trial Sponsors for COPPER

Sponsor Name

Sponsor Name for COPPER
Sponsor	Trials
National Cancer Institute (NCI)	8
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	7
University of Utah	7

Sponsor Type

Sponsor Type for COPPER
Sponsor	Trials
Other	233
Industry	40
NIH	34

Copper in Clinical Development and Market Analysis: A Strategic Overview

Last updated: October 31, 2025

Introduction

Copper, a trace element with vital biological functions, has garnered increasing attention in pharmaceutical research due to its potential therapeutic applications. As a nutritional supplement, adjunct therapy, and a candidate in investigational drugs, copper’s clinical trial landscape is evolving. This review synthesizes recent updates in clinical trials involving copper, assesses market dynamics, and projects future opportunities and challenges for stakeholders.

Clinical Trials Landscape for Copper

Current Scope of Clinical Trials

Across the global clinical trial registries, copper appears predominantly in trials targeting neurodegenerative disorders, infectious diseases, anemia, and wound healing. Notably, the utilization of copper-containing compounds, such as copper complexes and nanoparticles, signifies a trend toward targeted delivery and enhanced efficacy.

As per data from ClinicalTrials.gov (accessed February 2023), approximately 30 active or recruiting trials involve copper, with Phase 2 and Phase 3 studies primarily concentrated in neurodegenerative indications like Alzheimer’s and Parkinson’s diseases. These trials explore copper modulation to rectify dysregulated metal homeostasis implicated in disease pathology. For example, the Copper Aβ-targeting Therapeutics trials aim to mitigate amyloid aggregation.

Other ongoing studies investigate copper’s antimicrobial properties, especially in wound care and medical device coatings. The recent interest surged owing to copper’s broad-spectrum antimicrobial activity demonstrated in vitro, prompting clinical evaluation in hospitals and community healthcare setups.

Recent Outcomes and Challenges

Results from completed trials indicate mixed outcomes. Preliminary data on copper supplementation for neurodegeneration show modest cognitive improvements but with inconsistent replication. Safety profiles remain acceptable when administered within prescribed doses, although concerns about long-term accumulation and toxicity persist.

A key challenge in copper clinical trials is balancing efficacy with toxicity. Excess copper can induce oxidative stress, damaging tissues and leading to hepatic or neurological toxicity. Consequently, precise dosing, targeted delivery, and rigorous safety monitoring are paramount.

Market Analysis of Copper-based Therapeutics

Market Size and Segments

The global market for copper-based therapeutics remains in a nascent but upward trajectory. The broader metal-based drug market was valued at approximately USD 4 billion in 2021 [1], with copper-containing products representing a significant niche within antimicrobial and neurodegenerative segments.

The antimicrobial copper market alone is projected to grow at a CAGR of around 8.5% from 2022 to 2028, driven by healthcare-acquired infection (HAI) reduction needs, especially in hospitals and long-term care. Major end-use sectors include infection control coatings, wound dressings, and medical equipment.

In neurodegenerative therapeutics, the market is driven by heightened research funding, regulatory interest, and the high unmet medical need associated with Alzheimer’s and Parkinson’s. The global neurodegenerative disease therapeutics market is valued at approximately USD 12 billion in 2022 and is expected to grow at about 5% annually [2].

Key Players and Product Approvals

Current commercial products leveraging copper include Copper-infused wound dressings and antimicrobial surfaces adopted in endoscopy devices. However, no approved pharmaceutical formulations that predominantly rely on copper modulation for therapeutic efficacy have yet gained regulatory approval, signaling a high barrier for clinical and commercial validation.

Large biotech and pharmaceutical companies are investing in copper chelators and complexes as investigational drugs, aiming to integrate copper modulation into innovative treatment paradigms.

Regulatory and Market Barriers

Regulatory pathways for copper-based therapeutics are complex, primarily due to toxicity concerns and the need for convincing efficacy data. The absence of standardized biomarkers for copper status in clinical settings impedes clinical trial design and regulatory evaluation.

Market penetration faces hurdles from safety concerns, limited long-term data, and competition from existing approved drugs. Nevertheless, strategic collaborations and the development of targeted delivery systems could foster faster pathways to market.

Market Projections

Short-term Outlook (Next 5 Years)

The short-term outlook indicates cautious growth, primarily driven by antimicrobial applications and innovative delivery platforms. Increased investment in nano-formulations and targeted therapeutics may overcome current safety barriers.

The neurodegenerative segment, though promising, requires more definitive clinical results to translate into commercially viable drugs. Regulatory agencies may implement stricter safety and efficacy standards, which could extend development timelines.

Long-term Outlook (Next 10-15 Years)

In the longer term, the integration of copper modulation into combination therapies offers a promising avenue. Advances in nanotechnology, precision medicine, and biomarkers could facilitate personalized copper therapies.

Market expansion will depend on overcoming toxicity barriers—via chelation technologies, controlled release, or targeted delivery—and on establishing clear clinical benefit endpoints. If research confirms copper’s neuroprotective or antimicrobial efficacy convincingly, a multi-billion dollar market could emerge, similar to other metal-based therapeutics.

Strategic Opportunities and Considerations

• Innovative Delivery Technologies: Targeted nanocarriers, implants, and topical formulations could mitigate toxicity and improve efficacy.
• Regulatory Engagement: Early dialogue with agencies like the FDA and EMA can streamline development pathways.
• Biomarker Development: Enhanced diagnostics for copper imbalance could facilitate patient stratification and personalized approaches.
• Collaborative Research: Partnerships between academia, biotech, and pharma can accelerate clinical validation and commercialization.

Key Takeaways

• Copper’s therapeutic potential spans neurodegenerative diseases, antimicrobial applications, and wound healing, but clinical development remains early-stage.
• Toxicity management remains a key barrier; targeted delivery and controlled release formulations are pivotal.
• The antimicrobial market for copper-based coatings and products is the most mature, with steady growth prospects.
• Long-term market success hinges on validating copper’s efficacy and safety, developing biomarkers, and gaining regulatory approval.
• Strategic investments in nanotechnology and personalized medicine will influence future commercial viability.

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FAQs

1. What are the primary therapeutic applications of copper currently under clinical investigation?
Copper is mainly being investigated for neurodegenerative diseases (Alzheimer’s, Parkinson’s), antimicrobial uses in wound care and device coatings, and as an adjunct in anemia treatment, leveraging its role in enzyme function and metal homeostasis.

2. What are the safety concerns associated with copper-based therapies?
Excessive copper accumulation can cause oxidative stress, hepatotoxicity, and neurological damage. Ensuring precise dosing, delivery targeting, and monitoring copper levels are essential to mitigate these risks.

3. How does copper compare to other metal-based therapeutics?
While metals like gold, platinum, and iron have established roles in therapeutics, copper’s unique biological roles make it promising yet challenging. Unlike established drugs, copper therapies are largely experimental and face a higher regulatory barrier.

4. Which regulatory challenges do copper therapeutics face?
Regulatory hurdles include demonstrating a favorable benefit-risk profile, establishing efficacy in disease-modifying roles, managing toxicity risks, and developing suitable biomarkers for patient selection and monitoring.

5. What future technological innovations could accelerate copper’s clinical adoption?
Advancements in nanotechnology, targeted delivery systems, biomarker identification, and combination therapies are poised to overcome current limitations, enabling safer and more effective copper-based therapeutics.

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References

1. MarketsandMarkets. Metal-based drugs market size. 2022.
2. Grand View Research. Neurodegenerative disease therapeutics market. 2022.