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Last Updated: February 14, 2025

CLINICAL TRIALS PROFILE FOR FEXINIDAZOLE


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All Clinical Trials for Fexinidazole

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00982904 ↗ Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the Fexinidazole Completed Sanofi Phase 1 2009-09-01 This study is aimed at assessing the tolerability and pharmacokinetic parameters of the fexinidazole in healthy volunteers. In animal models of both acute and chronic experimental Trypanosomiasis infections, fexinidazole shows highly promising efficacy.
NCT00982904 ↗ Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the Fexinidazole Completed Drugs for Neglected Diseases Phase 1 2009-09-01 This study is aimed at assessing the tolerability and pharmacokinetic parameters of the fexinidazole in healthy volunteers. In animal models of both acute and chronic experimental Trypanosomiasis infections, fexinidazole shows highly promising efficacy.
NCT01340157 ↗ Fexinidazole (1200mg) Bioavailability Under Different Food Intake Conditions Completed Sanofi Phase 1 2011-02-01 The present study is designed to assess the impact of concomitant food intake on the relative bioavailability of a single oral fexinidazole tablet administration.
NCT01340157 ↗ Fexinidazole (1200mg) Bioavailability Under Different Food Intake Conditions Completed Drugs for Neglected Diseases Phase 1 2011-02-01 The present study is designed to assess the impact of concomitant food intake on the relative bioavailability of a single oral fexinidazole tablet administration.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Fexinidazole

Condition Name

Condition Name for Fexinidazole
Intervention Trials
Trypanosomiasis, African 4
Human African Trypanosomiasis (HAT) 3
Sleeping Sickness 3
Chagas' Disease (Chronic) Nos 1
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Condition MeSH

Condition MeSH for Fexinidazole
Intervention Trials
Trypanosomiasis 10
Trypanosomiasis, African 9
Chagas Disease 2
Leishmaniasis, Visceral 1
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Clinical Trial Locations for Fexinidazole

Trials by Country

Trials by Country for Fexinidazole
Location Trials
Congo, The Democratic Republic of the 8
Congo 6
France 4
Guinea 2
Malawi 1
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Clinical Trial Progress for Fexinidazole

Clinical Trial Phase

Clinical Trial Phase for Fexinidazole
Clinical Trial Phase Trials
Phase 3 1
Phase 2/Phase 3 5
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Fexinidazole
Clinical Trial Phase Trials
Completed 8
Recruiting 2
Terminated 2
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Clinical Trial Sponsors for Fexinidazole

Sponsor Name

Sponsor Name for Fexinidazole
Sponsor Trials
Drugs for Neglected Diseases 13
Sanofi 4
European and Developing Countries Clinical Trials Partnership (EDCTP) 1
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Sponsor Type

Sponsor Type for Fexinidazole
Sponsor Trials
Other 14
Industry 4
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Fexinidazole: A Breakthrough in Treating Neglected Diseases

Introduction

Fexinidazole, a groundbreaking drug developed by the Drugs for Neglected Diseases initiative (DNDi), has revolutionized the treatment of human African trypanosomiasis (HAT), also known as sleeping sickness, and is being explored for other neglected diseases. Here, we delve into the clinical trials, market analysis, and future projections for this pivotal medication.

Clinical Trials Update

Human African Trypanosomiasis (HAT)

Fexinidazole has been extensively tested in clinical trials for both forms of HAT: T.b. gambiense and T.b. rhodesiense.

T.b. gambiense

  • Clinical trials for T.b. gambiense have shown fexinidazole to be highly effective and safe for both stages of the disease in adults and children above six years and weighing over 20 kg. The drug was added to the World Health Organization’s (WHO) List of Essential Medicines in 2019 and is now recommended as the first-line treatment for T.b. gambiense sleeping sickness, except in cases of advanced disease where NECT remains the preferred choice[2][5].

T.b. rhodesiense

  • For the more acute and rapidly progressing T.b. rhodesiense, clinical trials conducted by DNDi and its partners have demonstrated fexinidazole's efficacy and safety. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for fexinidazole in treating T.b. rhodesiense in December 2023. This approval paves the way for its distribution in African countries where the disease is prevalent[1].

Chagas Disease

Fexinidazole has also been evaluated for the treatment of Chagas disease, caused by Trypanosoma cruzi.

  • A Phase 2 trial assessed fexinidazole at lower doses and shorter treatment durations due to previous tolerability issues. However, the study concluded that fexinidazole did not prove effective against T. cruzi infection, leading to the cessation of its development for this indication[4].

Market Analysis

Current Market Status

  • Distribution and Access: Fexinidazole is donated by Sanofi to WHO for distribution to national sleeping sickness control programs in disease-endemic countries. The first patient to receive fexinidazole outside of clinical trials was treated in the Democratic Republic of the Congo in March 2020[2].
  • Regulatory Approvals: Fexinidazole has received regulatory approvals in several countries, including the Democratic Republic of Congo and a positive opinion from the European Medicines Agency for both T.b. gambiense and T.b. rhodesiense[1][2].

Market Impact

  • WHO Guidelines: The inclusion of fexinidazole in WHO treatment guidelines as the first-line treatment for T.b. gambiense and T.b. rhodesiense has significantly impacted the management of HAT. This recommendation has streamlined treatment protocols and improved access to effective care in endemic regions[1][2].
  • Public Health: The availability of an all-oral treatment for HAT has simplified the treatment process, making it more feasible to administer in remote areas where the disease is prevalent. This has enhanced public health efforts to control and eliminate HAT as a public health problem[1].

Market Projections

Future Distribution and Access

  • With the recent CHMP opinion for T.b. rhodesiense, fexinidazole is expected to be widely distributed in Eastern and Southern Africa, where this form of the disease is most common. This will be facilitated through Foundation S, Sanofi’s philanthropic organization[1].
  • Expansion to New Regions: As more countries adopt fexinidazole as a first-line treatment, its availability is likely to expand beyond current endemic regions, further reducing the global burden of HAT.

Economic Impact

  • Cost-Effectiveness: Fexinidazole offers a cost-effective solution compared to traditional treatments, which are often toxic and difficult to administer. This could lead to significant economic savings for healthcare systems in affected countries[1][2].
  • Sustainability: The long-term sustainability of fexinidazole distribution will depend on continued support from donors, pharmaceutical companies, and global health organizations. The current model of donation and distribution through WHO is expected to continue, ensuring sustained access to this critical medication.

Expert Insights

  • Dr. Westain Nyirenda, Principal Investigator and physician at Rumphi Hospital in Malawi, highlighted the significance of fexinidazole: "Having a simple and safer oral pill to treat this frightening disease will allow doctors to rapidly save lives."[1]

Ethnographic and Community Impact

  • Ethnographic studies conducted by DNDi have helped in developing adapted communication materials to raise awareness of T.b. rhodesiense sleeping sickness among affected communities. This has improved early detection and treatment adherence, further enhancing the public health impact of fexinidazole[1].

Key Takeaways

  • Fexinidazole is the first all-oral treatment for both stages of HAT caused by T.b. gambiense and T.b. rhodesiense.
  • Clinical trials have demonstrated its efficacy and safety, leading to regulatory approvals and inclusion in WHO treatment guidelines.
  • The drug is expected to significantly improve public health outcomes in endemic regions through simplified treatment and increased access.
  • Future projections include expanded distribution, economic benefits, and sustained support from global health organizations.

FAQs

What is fexinidazole used for?

Fexinidazole is used as a treatment for human African trypanosomiasis (HAT), also known as sleeping sickness, caused by both T.b. gambiense and T.b. rhodesiense.

Who developed fexinidazole?

Fexinidazole was developed by the Drugs for Neglected Diseases initiative (DNDi) in collaboration with Sanofi.

Is fexinidazole effective for Chagas disease?

No, fexinidazole did not prove effective for the treatment of Chagas disease caused by Trypanosoma cruzi and its development for this indication has been stopped[4].

How is fexinidazole distributed?

Fexinidazole is donated by Sanofi to WHO for distribution to national sleeping sickness control programs in disease-endemic countries.

What are the benefits of fexinidazole over traditional treatments?

Fexinidazole offers a simpler, safer, and more cost-effective treatment option compared to traditional treatments, which are often toxic and difficult to administer.

Sources

  1. DNDi: Fexinidazole for T.b. rhodesiense - DNDi
  2. DNDi: Fexinidazole for T.b. gambiense - DNDi
  3. FDA: 214429Orig1s000 - accessdata.fda.gov
  4. PubMed: Efficacy and safety of fexinidazole for treatment of chronic ... - PubMed
  5. PubMed: Fexinidazole: First Global Approval - PubMed

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