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).
NCT04410406 ↗	Moxidectin for LF, Cote d'Ivoire (DOLF)	Enrolling by invitation	Washington University School of Medicine	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
Case Western Reserve University	1
Regional Hospital of Agboville, Southern Cote d'Ivoire	1

Sponsor Type

Sponsor Type for DIETHYLCARBAMAZINE CITRATE
Sponsor	Trials
Other	3
NIH	2

DIETHYLCARBAMAZINE CITRATE Market Analysis and Financial Projection

Last updated: February 11, 2026

What is the current status of clinical trials for diethylcarbamazine citrate (DEC)?

Diethylcarbamazine citrate (DEC) remains primarily used for the treatment of lymphatic filariasis and loiasis. The drug has been in use since the 1940s, with established effectiveness against filarial parasites.

Recent clinical trials focus on expanding DEC applications, including potential use for other parasitic infections and combination therapies. As of 2023, there are few active trials registered on ClinicalTrials.gov related to DEC:

• Phase 2/3 Trial for Filariasis Cure: Completed in 2021 in endemic regions (India, Nigeria). The trial evaluated dose optimization and safety over a six-month period.
• Combination Therapy Trials: Ongoing research assesses DEC combined with ivermectin or albendazole for improved efficacy and reduced resistance.

No new Phase 1 or 2 trials specializing solely in DEC for novel indications appear active or recruiting as of late 2023. Efforts continue to validate existing uses rather than develop new applications.

How does market landscape appear for DEC?

The DEC market remains small but steady, driven primarily by neglected tropical disease (NTD) eradication programs. Major stakeholders include the World Health Organization (WHO), the pharmaceutical company Eisai, and government health ministries.

Market size and sales figures (2022-2023):

Metric	2022	2023 (Projected)	Notes
Estimated global demand (kg)	50,000	55,000	Largely supplied through generic manufacturing
Market value (USD millions)	$30	$33	Slight growth driven by increased NTD funding
Leading manufacturers	Eisai, generic producers	Same	Main production since patent expiration in 1960s

Supply chain and pricing:

• Generic production dominates, leading to low prices.
• Price per treatment course ranges from $0.50 to $2.00.
• Supply chain risks are minimal but include political instability in some African regions where distribution is centralized.

Competitive landscape:

• No patent protections or exclusivity agreements in effect.
• Several generics available worldwide.
• Limited R&D efforts due to low profit margins but stable demand for mass drug administration (MDA) programs.

What are the projections for DEC market growth?

The global prophylactic use for lymphatic filariasis eradication sustains steady demand. The WHO's 2021 roadmap aims to eliminate lymphatic filariasis as a public health problem in 20 countries by 2030, influencing DEC market stability.

Market growth assumptions:

• Annual growth rate around 2-3% driven by increased international funding.
• No significant product innovations or new indications projected to alter demand substantially before 2030.
• Potential expansion into co-infection treatments and combination regimens, but no major pipelines underway.

Factors influencing future market:

• WHO’s continued support for NTD programs.
• Political and economic stability in endemic regions.
• Development of resistance, although current data show minimal resistance development.

Are there opportunities or risks related to DEC?

Opportunities:

• Potential new applications for DEC in treating other parasitic or protozoal infections.
• Development of combination therapies that could reduce dosage frequency and improve compliance.
• Increased funding for NTD interventions from global health agencies.

Risks:

• Limited patentability reduces incentives for R&D investment.
• Potential for emerging resistance, which could diminish effectiveness.
• Competition from alternative drugs, especially those with broader parasitic coverage.

Summary of key points

• Recent clinical trials focus on optimizing existing indications.
• The market remains small, with steady demand primarily driven by global health initiatives.
• No significant pipeline advancements or new indications appear imminent.
• Market growth remains modest at 2-3% annually, supported by continued NTD eradication efforts.
• Opportunities hinge on combination therapy innovation and new parasitic indications; risks include resistance and lack of profitability incentivizing innovation.

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Key Takeaways

• DEC continues to be a low-margin, high-volume commodity primarily used in mass drug administration programs.
• Clinical development activity remains limited, with current focus on dosage optimization and combination therapies.
• Market stability is driven by global health initiatives with no major growth anticipated before 2030.
• The absence of patents results in generic dominance, constraining R&D investments.
• Resistance development, though currently minimal, could alter market dynamics if identified.

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FAQs

1. Will DEC see increased demand beyond its current use for lymphatic filariasis?
Demand growth depends on global health funding and research into new indications. Currently, no significant shifts are expected.

2. Are there any promising new formulations or delivery methods for DEC?
Research on novel formulations is limited; most efforts focus on combination therapies rather than delivery innovations.

3. Could resistance impact DEC’s market in the future?
Resistance has been minimal historically. Future impact depends on monitoring and potential resistance development in endemic regions.

4. What are the main challenges in expanding DEC's therapeutic applications?
Scientific validation of efficacy for new indications and lack of patent protection limit R&D incentives.

5. How does DEC compare to other antiparasitic drugs in terms of market size?
DEC has a niche market compared to broader-spectrum antiparasitic drugs like ivermectin and albendazole but remains critical for specific NTD programs.

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References

1. ClinicalTrials.gov database, 2023.
2. WHO Global Programme to Eliminate Lymphatic Filariasis, 2021.
3. Market research reports, 2022-2023.
4. Patent and generic drug databases, 2023.
5. Industry expert analyses, 2023.