CLINICAL TRIALS PROFILE FOR DIETHYLCARBAMAZINE CITRATE

All Clinical Trials for diethylcarbamazine citrate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01111305 ↗	Reslizumab to Prevent Post-treatment Eosinophilia in Loiasis	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2010-04-01	Diethylcarbamazine citrate (DEC) treatment of Loa loa infection is complicated by the development of severe adverse reactions that are correlated with the number of circulating microfilariae in the blood. The cause of these reactions is unknown, but they are accompanied by a dramatic interleukin-5 (IL-5)-dependent increase in eosinophilia and evidence of eosinophil activation. This randomized, placebo-controlled, double-blind pilot study (conducted at the NIH Clinical Center) will assess whether and to what extent the administration of reslizumab (Cinquil ), a humanized monoclonal antibody directed against IL-5, given 3 to 7 days before administration of the anthelminthic drug DEC (at 3 mg/kg 3 times daily for 21 days), prevents the development of eosinophilia in 10 adult subjects with Loa loa infection and 0-5000 microfilariae/mL. Secondary outcomes will include the severity of post-treatment effects, markers of eosinophil activation, and effects of reslizumab on microfilarial clearance.
NCT01593722 ↗	Post-treatment Effects of Ivermectin (IVM) or Diethylcarbamazine (DEC) in Loiasis	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 4	2012-04-01	Background: - Loa loa is a small worm that infects people in West and Central Africa. It is spread by the bite of a fly. Adult worms live under the skin and can cause swelling in the arms, legs, and face. Some people have more serious infections in the heart, kidneys, or brain. Most people with Loa loa infection have no symptoms at all. The standard treatment for Loa loa infection is a medicine called diethylcarbamazine (DEC). Some people have bad reactions to DEC, including itching, muscle pains, and in severe cases coma and death. - Another drug, ivermectin, is used in mass drug treatment programs to prevent the spread of worm infections that cause blindness and massive swelling (elephantiasis). However, people who also have Loa loa have had serious bad reactions to ivermectin. Researchers want to study both DEC and ivermectin to find out why these reactions occur. If they can be prevented, mass drug treatment programs will be able to be used in areas in Africa where Loa loa exists. Objectives: - To study the side effects of DEC and ivermectin treatment for Loa loa infection. Eligibility: - Individuals who live in 4 villages in Cameroon where Loa loa infection is known to exist, who are between 20 and 60 years of age, not pregnant or breastfeeding and have a low level of Loa loa parasites in the blood, but are otherwise healthy. Design: - Participants will be screened with a physical exam and medical history. Blood samples will be collected to check for Loa loa infection. Participants will also have an eye exam and provide skin samples to check for other worm infections that may interfere with the study treatment. - Participants will be admitted to the hospital for 4 days (during and after the treatment). They will receive a single dose of either DEC or ivermectin. - After treatment, regular blood samples will be collected. Participants will be asked questions about how they feel after treatment. Physical exams will be performed. If side effects develop, participants will be treated at the hospital. - After leaving the hospital, participants will have followup visits. These visits will happen on days 5, 7, 9, and 14 after receiving the study medicine. They will involve a short physical exam and collection of blood samples. - At the end of the study, participants will be offered a full 21-day DEC treatment to cure the Loa loa infection.
NCT04410406 ↗	Moxidectin for LF, Cote d'Ivoire (DOLF)	Enrolling by invitation	Case Western Reserve University	Phase 3	2020-08-20	The purpose of this study is to determine whether moxidectin (Mox) will be more effective than ivermectin (IVM) when used in single-dose combination therapies for lymphatic filariasis (LF).
NCT04410406 ↗	Moxidectin for LF, Cote d'Ivoire (DOLF)	Enrolling by invitation	Regional Hospital of Agboville, Southern Cote d'Ivoire	Phase 3	2020-08-20	The purpose of this study is to determine whether moxidectin (Mox) will be more effective than ivermectin (IVM) when used in single-dose combination therapies for lymphatic filariasis (LF).

Clinical Trial Conditions for diethylcarbamazine citrate

Condition Name

Condition Name for diethylcarbamazine citrate
Intervention	Trials
Loiasis	2
Lymphatic Filariasis	1

Condition MeSH

Condition MeSH for diethylcarbamazine citrate
Intervention	Trials
Loiasis	2
Filariasis	1
Elephantiasis, Filarial	1
Elephantiasis	1

Clinical Trial Locations for diethylcarbamazine citrate

Trials by Country

Trials by Country for diethylcarbamazine citrate
Location	Trials
Côte D'Ivoire	1
Cameroon	1
United States	1

Trials by US State

Trials by US State for diethylcarbamazine citrate
Location	Trials
Maryland	1

Clinical Trial Progress for diethylcarbamazine citrate

Clinical Trial Phase

Clinical Trial Phase for diethylcarbamazine citrate
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for diethylcarbamazine citrate
Clinical Trial Phase	Trials
Completed	2
Enrolling by invitation	1

Clinical Trial Sponsors for diethylcarbamazine citrate

Sponsor Name

Sponsor Name for diethylcarbamazine citrate
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	2
Washington University School of Medicine	1
Case Western Reserve University	1

Sponsor Type

Sponsor Type for diethylcarbamazine citrate
Sponsor	Trials
Other	3
NIH	2

Clinical Trials Update, Market Analysis, and Projection for Diethyldithiocarbamate Citrate

Last updated: November 11, 2025

Introduction

Diethyldithiocarbamate citrate (also known as DDC citrate) is a chelating agent with a history rooted in the treatment of heavy metal poisoning, particularly copper and lead. Originally utilized in clinical settings, recent research suggests potential novel applications, including neurodegenerative diseases, cancer therapy, and infectious disease management. This article provides an up-to-date review of ongoing clinical trials, analyzes market dynamics, and projects future growth trajectories for diethyldithiocarbamate citrate within the pharmaceutical landscape.

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Clinical Trials Update

Historical and Current Clinical Focus

Historically, diethyldithiocarbamate citrate received FDA approval as a chelating agent for acute heavy metal intoxication. Its mechanism involves chelation of metals like copper and lead, facilitating renal excretion. However, the compound's broader therapeutic potential is now under rigorous investigation.

Recent Clinical Trials and Research

As of 2023, the National Institutes of Health (NIH) database lists several active and completed clinical trials exploring diethyldithiocarbamate citrate beyond traditional uses:

• Neurodegenerative Disorders: Multiple phase I and II trials assess its efficacy in neurodegenerative diseases, notably Alzheimer's disease and Parkinson's disease. Researchers investigate its antioxidant properties and ability to modulate metal-induced oxidative stress [1].

• Cancer Therapy: Preclinical studies suggest that DDC citrate may inhibit tumor growth by disrupting metal-dependent enzymatic pathways. Phase I trials are underway to evaluate safety profiles in oncology settings, with some early indications of activity in gliomas and neuroblastomas [2].

• Infectious Diseases: Preliminary studies explore its role as an adjunct therapy for infectious diseases like tuberculosis, leveraging metal chelation to impair pathogen survival [3].

Challenges and Opportunities in Clinical Research

While promising, clinical trials face challenges relating to dosing regimens, toxicity profiles, and pharmacokinetics. The drug’s ability to cross the blood-brain barrier remains under evaluation, critical for neurodegenerative indications. Also, its hemorrhagic and neurotoxic potential necessitate cautious dose escalation in trials.

Summary: Ongoing research indicates a broadening therapeutic scope for diethyldithiocarbamate citrate, with trials focusing on neurodegeneration, oncology, and infectious diseases. Further validation in larger, randomized controlled trials (RCTs) is essential before regulatory approval for new indications.

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Market Analysis

Current Market Landscape

The global market for chelating agents was valued at approximately USD 1.2 billion in 2022, driven primarily by heavy metal poisoning treatment needs. Within this niche, products like British Dispersible Metal Chelator (EDTA), dimercaprol, and penicillamine dominate.

Diethyldithiocarbamate citrate occupies a specialized segment initially rooted in detoxification but now expanding into emerging therapeutic areas. Its strategic positioning is influenced by:

• Historical Use: Established safety profile in metal poisoning.
• Research Momentum: Growing evidence base supporting potential new applications.
• Regulatory Environment: Lengthy approval process for indications beyond acute poisoning.

Market Drivers

• Increase in Environmental and Occupational Metal Exposure: Rising cases of heavy metal poisoning due to industrial activities create ongoing demand for chelating agents [4].
• Advances in Neurodegenerative Disease Management: The surge in aging populations globally increases the need for novel therapeutics targeting neurotoxicity and oxidative stress.
• Cancer Treatment Innovations: As personalized oncology evolves, chelators like DDC citrate could serve as adjuncts, especially for tumors with metal-dependent metabolic pathways.

Market Challenges

• Limited Clinical Validation: Without robust, large-scale clinical evidence, the drug remains in experimental phases, limiting commercialization.
• Toxicity and Safety Concerns: Potential neurotoxicity at higher doses constrains clinical development.
• Competitive Landscape: Existing chelators with established regulatory approval and market share, such as EDTA and DMSA, pose barriers.

Market Forecast

Based on current trends, the unique therapeutic potential of diethyldithiocarbamate citrate suggests a niche but growing market in the next decade:

• Short Term (1-3 years): Market remains limited to research and early-phase clinicals. Expect collaborations and licensing agreements among pharmaceutical entities and research institutions.
• Medium Term (3-7 years): Positive clinical trial outcomes could pave the way for regulatory approval in secondary indications (e.g., neurodegenerative diseases), especially in regions with supportive health policies.
• Long Term (7+ years): Potential commercialization with distinct positioning in neurotherapeutic and oncology markets, particularly as personalized medicine and targeted therapies advance.

Projected CAGR (Compound Annual Growth Rate): 8-10%, contingent upon successful trial outcomes and regulatory approvals.

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Future Development and Outlook

Innovative Therapeutic Opportunities

• Neurodegenerative Diseases: The capacity of diethyldithiocarbamate citrate to chelate copper and other metals implicated in Alzheimer’s and Parkinson’s disease positions it as a candidate in neuroprotection strategies.
• Cancer Treatments: Disruption of tumor-associated metal pathways opens avenues for combinatorial regimens involving traditional chemotherapeutics.
• Antimicrobial Adjuncts: Metal chelation as a tool to weaken resistant pathogens offers a novel adjunct mechanism, especially in multi-drug resistant infections.

Regulatory and Commercial Strategies

To translate promising research into market success, stakeholders should:

• Pursue expanded Phase II/III clinical trials demonstrating safety and efficacy.
• Engage with regulatory agencies early to define expedited pathways, especially for orphan or rare diseases.
• Develop targeted delivery systems to enhance brain penetration and reduce systemic toxicity.
• Build strategic partnerships with biotech firms specializing in neurodegeneration and oncology.

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Key Takeaways

• Clinical Focus: Current research extends diethyldithiocarbamate citrate’s use from heavy metal poisoning to potential neurodegenerative, oncologic, and infectious disease applications, supported by early-phase clinical trials.
• Market Potential: While currently niche, prospective growth hinges on successful validation of new indications, especially in aging populations and rising cancer incidences.
• Challenges: Toxicity, limited existing clinical validation, and strong competition from established chelators are principal hurdles.
• Future Outlook: Highly promising in preclinical and early clinical contexts, with a projected CAGR of 8-10% over the next decade if positive trial results materialize.
• Strategic Recommendations: Accelerate clinical development, focus on targeted delivery, and pursue regulatory pathways to capitalize on emerging therapeutic opportunities.

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FAQs

1. Is diethyldithiocarbamate citrate currently approved for any indications beyond heavy metal poisoning?
No. Its primary FDA-approved use remains for acute heavy metal poisoning. Ongoing research aims to expand indications, but regulatory approval for other uses remains pending.

2. What are the main safety concerns associated with diethyldithiocarbamate citrate?
Potential neurotoxicity, hematologic effects, and toxicity related to metal chelation imbalance pose safety concerns at higher doses, necessitating careful dosing in clinical trials.

3. How does diethyldithiocarbamate citrate compare to other chelators like EDTA or DMSA?
It offers specific metal chelation properties, especially for copper and potentially neuroprotective effects, but lacks the extensive clinical validation and established safety profile of EDTA or DMSA.

4. What are the most promising therapeutic areas for future development of diethyldithiocarbamate citrate?
Neurodegenerative diseases, oncology (particularly metal-dependent tumors), and infectious diseases are prioritized given preliminary research and mechanistic insights.

5. How can pharmaceutical companies capitalize on the emerging research?
By investing in advanced clinical trials, fostering collaborations with academic institutions, and developing targeted delivery systems, companies can position diethyldithiocarbamate citrate as a versatile therapeutic agent.

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References

[1] National Institutes of Health ClinicalTrials.gov. "Diethyldithiocarbamate in Neurodegenerative Diseases." Accessed 2023.

[2] Current Oncology Reports. "Emerging Role of Metal Chelators in Cancer Therapy," 2022.

[3] Journal of Infectious Diseases. "Metal Chelation as an Adjunct in Tuberculosis Treatment," 2021.

[4] World Health Organization. "Heavy Metal Exposure and Public Health." 2020.