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Last Updated: June 14, 2025

CLINICAL TRIALS PROFILE FOR COPPER


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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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Copper

Condition Name

Condition Name for Copper
Intervention Trials
Contraception 22
HIV 8
Wilson Disease 6
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Condition MeSH

Condition MeSH for Copper
Intervention Trials
Hepatolenticular Degeneration 7
Glioblastoma 7
Breast Neoplasms 7
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Clinical Trial Locations for Copper

Trials by Country

Trials by Country for Copper
Location Trials
United States 205
Egypt 12
United Kingdom 7
India 7
Canada 4
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Trials by US State

Trials by US State for Copper
Location Trials
California 17
New York 16
Michigan 16
Pennsylvania 15
Texas 12
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Clinical Trial Progress for Copper

Clinical Trial Phase

Clinical Trial Phase for Copper
Clinical Trial Phase Trials
Phase 4 23
Phase 3 14
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Copper
Clinical Trial Phase Trials
Completed 82
Recruiting 26
Terminated 16
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Clinical Trial Sponsors for Copper

Sponsor Name

Sponsor Name for Copper
Sponsor Trials
National Cancer Institute (NCI) 8
University of Utah 7
Cairo University 7
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Sponsor Type

Sponsor Type for Copper
Sponsor Trials
Other 223
Industry 38
NIH 34
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Telomir-1: A Promising Drug for Copper-Related Disorders

Introduction

Telomir Pharmaceuticals has made significant strides in the development of Telomir-1, a drug that shows considerable promise in treating copper-related disorders, particularly Wilson's disease. Here, we will delve into the clinical trials update, market analysis, and projections for this groundbreaking drug.

Clinical Trials Update

Copper Binding Capabilities

Recent preclinical studies have demonstrated Telomir-1's exceptional binding affinity for copper ions, as well as its ability to bind and exchange other key ions such as iron and zinc. These findings are crucial for its potential application in treating Wilson's disease, a rare genetic disorder characterized by excessive copper accumulation in the body[1][4].

IND-Enabling Studies

Telomir Pharmaceuticals plans to conduct IND-enabling safety studies in Q2 2025, with the goal of submitting an Investigational New Drug (IND) application by Q4 2025. First-in-human clinical trials are anticipated to begin in the first half of 2026. This timeline is ambitious but reflects the company's commitment to bringing transformative therapies to patients quickly[1][4].

Multiple Therapeutic Applications

In addition to Wilson's disease, Telomir-1 is being explored for its potential in treating other conditions, including Type 2 diabetes, Progeria, cancer, and Alzheimer's disease. The drug's versatility and unique mechanism of action make it a promising candidate for addressing a range of critical unmet medical needs[1][4].

Manufacturing Optimization

The company is focusing on optimizing manufacturing processes to ensure an affordable and scalable approach. This includes producing GMP-grade quantities necessary for IND-enabling studies and clinical trials. The dual application of Telomir-1 in both human and veterinary medicine is also being pursued, with plans to secure an INAD for pets[1][4].

Market Analysis

Global Copper Market

The global copper market is expected to remain strong, driven by growing demand from sectors linked to the energy transition, such as electric vehicles and renewable energy applications. By 2025, the copper grade A cathode premium in Rotterdam is projected to rise by approximately 25%, reflecting tighter regional fundamentals and a recovering European market[2].

Demand Drivers

The demand for copper is anticipated to grow at a compound annual growth rate (CAGR) of 2.6% until 2034, with energy transition sectors driving a significant portion of this growth. Electric vehicles, solar power, and wind power applications are expected to see CAGRs of 14.3%, 5.6%, and 9.3%, respectively[2].

Regional Dynamics

China remains a critical player in the global copper market, with its focus on green energy and electric vehicles driving significant demand. The US copper market is also expected to see a modest increase in demand, driven by government infrastructure projects and a growing emphasis on renewable energy[2][5].

Market Projections for Telomir-1

Addressing Unmet Medical Needs

Telomir-1's potential to address the significant unmet need in Wilson's disease and other copper-related disorders positions it for substantial market impact. By targeting the underlying causes of these diseases rather than just managing symptoms, Telomir-1 could offer a transformative therapy for patients[1][4].

Competitive Landscape

The current treatment landscape for Wilson's disease includes copper chelators and zinc, but these treatments often have limitations and side effects. Telomir-1's unique mechanism of action and its ability to selectively interact with and regulate copper metabolism could make it a preferred treatment option, potentially disrupting the existing market[3].

Financial Outlook

Telomir Pharmaceuticals has secured additional financing at a 20% premium without warrants, which will support the ongoing research and development of Telomir-1. The company's financial stability and strategic funding will be crucial in navigating the complex and costly process of bringing a new drug to market[1].

Challenges and Opportunities

Regulatory and Development Challenges

The ambitious timeline for IND-enabling studies and clinical trials may be challenging due to the complexity of safety studies required for a novel compound with multiple mechanisms of action. However, the company's scientific integrity and commitment to ethical research practices, as seen in the pivot to naturally occurring osteoarthritis in dogs, are positive indicators of its ability to navigate these challenges[1].

Market Sensitivity

The copper market, which indirectly influences the demand for treatments related to copper disorders, remains sensitive to macro-economic conditions and geopolitical events. A strong US dollar and weaker industrial demand in Western economies could disrupt prices, but the long-term outlook remains positive due to the escalating demand driven by the energy transition[2][5].

Key Takeaways

  • Copper Binding Capabilities: Telomir-1 has shown exceptional binding affinity for copper ions, making it a promising candidate for treating Wilson's disease.
  • Clinical Trials Timeline: IND-enabling safety studies are planned for Q2 2025, with first-in-human clinical trials expected in H1 2026.
  • Multiple Therapeutic Applications: Telomir-1 is being explored for its potential in treating Type 2 diabetes, Progeria, cancer, and Alzheimer's disease.
  • Market Demand: The global copper market is expected to remain strong, driven by demand from energy transition sectors.
  • Financial Stability: Telomir Pharmaceuticals has secured additional financing to support the development of Telomir-1.

FAQs

Q: What is Wilson's disease, and how does Telomir-1 address it?

Wilson's disease is a rare genetic disorder characterized by excessive copper accumulation in the body. Telomir-1 addresses this by selectively interacting with and regulating copper metabolism, potentially offering a more effective treatment than current options.

Q: What are the key findings from the preclinical studies of Telomir-1?

Preclinical studies have demonstrated Telomir-1's exceptional binding affinity for copper ions and its ability to bind and exchange other key ions such as iron and zinc.

Q: When are the first-in-human clinical trials for Telomir-1 expected to begin?

First-in-human clinical trials for Telomir-1 are anticipated to begin in the first half of 2026.

Q: How does the global copper market impact the development and market potential of Telomir-1?

The global copper market's strong demand, driven by the energy transition, indirectly supports the need for effective treatments of copper-related disorders, positioning Telomir-1 for significant market impact.

Q: What other conditions is Telomir-1 being explored for?

In addition to Wilson's disease, Telomir-1 is being explored for its potential in treating Type 2 diabetes, Progeria, cancer, and Alzheimer's disease.

Sources

  1. Telomir Pharmaceuticals Confirms Copper Binding Capabilities of Telomir-1 and Expands Pipeline Into Wilson's Disease. Stock Titan.
  2. Copper prices in 2024 and 2025: a global overview and analysis. Fastmarkets.
  3. Ultragenyx Initiates Cyprus2+, a Pivotal Clinical Trial Evaluating UX701 for the Treatment of Wilson Disease. Ultragenyx.
  4. Telomir Pharmaceuticals Confirms Copper Binding Capabilities of Telomir-1 and Expands Pipeline Into Wilson's Disease. BioSpace.
  5. How global copper, nickel markets will drive cobalt outlook 2025. Fastmarkets.
Last updated: 2025-01-01

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