CLINICAL TRIALS PROFILE FOR BILTRICIDE

All Clinical Trials for BILTRICIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01154907 ↗	Prevention of Female Genital Schistosomiasis (FGS) in Rural High-endemic South Africa	Recruiting	Leiden University Medical Center		2010-04-01	Schistosomiasis is a poverty-related water-transmitted parasitic disease affecting more that 200 million people world wide. Infection with Schistosoma haematobium may cause Female Genital Schistosomiasis (FGS) with pathological lesions in the female genital tract, especially the cervix. Findings indicate that FGS is a hitherto under-diagnosed illness of young women in endemic poor tropical countries, deserving further attention. A cross-sectional study from Zimbabwe indicated that the pathologic genital lesions were unchanged two years after praziquantel treatment in adult women whereas in those who had been treated with praziquantel in childhood the prevalence of genital lesions was significantly lower. Furthermore, a higher prevalence of HIV was detected in women with FGS compared to those without. The proposed project aims at achieving a better understanding of how annual distribution of praziquantel to pre- and post-pubertal schoolgirls may prevent FGS. This information can be of use in current schistosomiasis control programs in the near term resulting in improved strategies for treatment. Preventing or reducing the risk of FGS and genital lesions will lead to improved reproductive health among in women living in schistosomiasis endemic areas. Project Goal: Contribute to a reduction of the global burden of female genital schistosomiasis (FGS) through improved knowledge about the prevention of gynecological lesions and through improved diagnosis of FGS.
NCT01054651 ↗	A Randomised Trial of Artesunate-sulfamethoxypyrazine/Pyrimethamine Versus Praziquantel for the Treatment of S. Mansoni	Completed	Dafra Pharma	Phase 3	2009-10-01	The purpose of this study is to determine the comparative efficacy of artesunate plus sulfamethoxypyrazine-pyrimethamine versus Praziquantel in the treatment of school children infected with S.mansoni in western Kenya.
NCT01054651 ↗	A Randomised Trial of Artesunate-sulfamethoxypyrazine/Pyrimethamine Versus Praziquantel for the Treatment of S. Mansoni	Completed	Kenya Medical Research Institute	Phase 3	2009-10-01	The purpose of this study is to determine the comparative efficacy of artesunate plus sulfamethoxypyrazine-pyrimethamine versus Praziquantel in the treatment of school children infected with S.mansoni in western Kenya.
NCT00713999 ↗	Urogenital Schistosomiasis and Sexually Transmitted Infections in Madagascar	Completed	Statens Serum Institut	N/A	2001-08-01	A cross-sectional study of urogenital schistosomiasis and sexually transmitted infections (STI) prevalence and associated morbidity in a rural community in Madagascar. Clearance of infections and resolution of morbidity were subsequently studied in two phases following systematic anti-STI and anti-schistosoma treatment, respectively.
NCT00713999 ↗	Urogenital Schistosomiasis and Sexually Transmitted Infections in Madagascar	Completed	University of Aarhus	N/A	2001-08-01	A cross-sectional study of urogenital schistosomiasis and sexually transmitted infections (STI) prevalence and associated morbidity in a rural community in Madagascar. Clearance of infections and resolution of morbidity were subsequently studied in two phases following systematic anti-STI and anti-schistosoma treatment, respectively.

Clinical Trial Conditions for BILTRICIDE

Condition Name

Condition Name for BILTRICIDE
Intervention	Trials
Schistosomiasis	3
Healthy	2
Schistosoma Mansoni	2
Bilharzia	1

Condition MeSH

Condition MeSH for BILTRICIDE
Intervention	Trials
Schistosomiasis	5
Schistosomiasis haematobia	2
Infections	1
Infection	1

Clinical Trial Locations for BILTRICIDE

Trials by Country

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Trials by Country for BILTRICIDE
Location	Trials
Kenya	2
Côte D'Ivoire	2
Egypt	2
Germany	2
Madagascar	1

Clinical Trial Progress for BILTRICIDE

Clinical Trial Phase

Clinical Trial Phase for BILTRICIDE
Clinical Trial Phase	Trials
Phase 3	3
Phase 2/Phase 3	1
Phase 1	2

Clinical Trial Status

Clinical Trial Status for BILTRICIDE
Clinical Trial Phase	Trials
Completed	7
Not yet recruiting	1
Recruiting	1

Clinical Trial Sponsors for BILTRICIDE

Sponsor Name

Sponsor Name for BILTRICIDE
Sponsor	Trials
Merck KGaA, Darmstadt, Germany	2
Kenya Medical Research Institute	2
Leiden University Medical Center	2

Sponsor Type

Sponsor Type for BILTRICIDE
Sponsor	Trials
Other	19
Industry	6

Clinical Trials and Recent Developments for BILTRICIDE (Praziquantel)

Introduction to BILTRICIDE

BILTRICIDE, also known as praziquantel, is an anthelmintic medication used to treat infections caused by various types of worms, including schistosomes and liver flukes. Here, we will delve into recent clinical trials, market analysis, and projections for this crucial drug.

Clinical Trials Update

Arpraziquantel for Young Children

A significant development in the treatment of schistosomiasis involves Arpraziquantel, a formulation of praziquantel specifically designed for young children. Clinical trials conducted by the Pediatric Praziquantel Consortium have shown very high cure rates in children aged 3 months to 6 years. These trials, which included 442 children, reported no parasite eggs in the stool or urine weeks after treatment, indicating a highly effective treatment[1].

Safety and Adverse Events

The most frequently reported adverse events in these trials were abdominal pain, diarrhea, and vomiting. Despite these side effects, the overall safety profile of Arpraziquantel has been deemed satisfactory, paving the way for its use in preschool-aged children[1].

Regulatory Approval

The European Medicines Agency (EMA) has adopted a positive scientific opinion for Arpraziquantel under the EU-M4all procedure, which streamlines the WHO prequalification and national registration processes for high-priority medicines intended for markets outside the European Union. This approval is crucial for global regulatory capacity building and public health protection in endemic regions[1].

Market Analysis

Global Anthelmintics Market

The global anthelmintics market, which includes praziquantel, is projected to grow significantly. In 2021, the market was valued at USD 2846.90 million and is expected to reach USD 5435.60 million by 2029, with a Compound Annual Growth Rate (CAGR) of 8.42%[3].

Key Drivers

Several factors are driving this growth:

• Increasing Healthcare Expenditure: Rising healthcare expenditure is improving infrastructure and facilitating better access to anthelmintic medications.
• Government Initiatives: Programs like India's National Deworming Day and other global initiatives are boosting awareness and treatment of helminth infections, thereby increasing demand for anthelmintics[3].
• Research and Development: The increase in research and development activities, including AI-driven drug development approaches, is expected to capitalize on revenue creation potential and expand the market[3].

Market Segments

The anthelmintics market is segmented based on drug class, target pathogen, application, route of administration, end-users, and distribution channels. Praziquantel, being a key drug in this market, is used for various applications including schistosomiasis, clonorchiasis, and opisthorchiasis[3].

Market Projections

Growth Opportunities

The market for anthelmintics, including praziquantel, is expected to grow due to several opportunities:

• Emerging Markets: New markets, particularly in regions where helminth infections are prevalent, offer significant growth potential.
• Strategic Collaborations: Collaborations aimed at finding new treatments for various helminth infections will create new market opportunities[3].
• Clinical Trials: The rise in the number of clinical trials, including those for coronavirus treatment using existing anthelmintics, will further fuel market growth[3].

Challenges and Restraints

Despite the growth potential, there are challenges to consider:

• Price Fluctuations: The cost of praziquantel has experienced significant fluctuations, with a notable 356% price increase for the brand-name Biltricide in 2015. Current retail prices for generic praziquantel and Biltricide remain relatively high[5].
• Resistance Concerns: Although widespread clinical resistance to praziquantel has not occurred, there are reports of limited resistance in heavily infected populations, which could impact future efficacy[4].

Treatment and Usage

Dosage and Administration

Praziquantel is effective against all major Schistosoma species and is administered orally. The dosage varies depending on the species of the parasite:

• For Schistosoma mansoni, S. haematobium, S. intercalatum: 40 mg/kg per day in two divided doses for one day.
• For S. japonicum, S. mekongi: 60 mg/kg per day in three divided doses for one day[4].

Pregnancy and Lactation

Praziquantel is a pregnancy category B drug, meaning there are no adequate and well-controlled studies in pregnant women, but available evidence suggests no significant adverse birth outcomes. It is also excreted in low concentrations in breast milk, and its use during lactation is generally encouraged in mass drug administration campaigns[4].

Key Takeaways

• High Cure Rates: Recent clinical trials of Arpraziquantel have shown very high cure rates in young children.
• Regulatory Approval: EMA's positive scientific opinion for Arpraziquantel facilitates global regulatory approval and public health protection.
• Market Growth: The global anthelmintics market is projected to grow significantly, driven by increasing healthcare expenditure, government initiatives, and research activities.
• Challenges: Price fluctuations and potential resistance concerns need to be addressed.

FAQs

What is BILTRICIDE used for?

BILTRICIDE (praziquantel) is used to treat infections caused by schistosomes and liver flukes, including schistosomiasis, clonorchiasis, and opisthorchiasis[2].

What are the common side effects of BILTRICIDE?

Common side effects include abdominal pain, diarrhea, and vomiting[1].

How is BILTRICIDE administered?

BILTRICIDE is administered orally, with the dosage varying depending on the species of the parasite[4].

Is BILTRICIDE safe for pregnant women?

Praziquantel is a pregnancy category B drug, and while there are no adequate and well-controlled studies, available evidence suggests no significant adverse birth outcomes. Its use is generally encouraged in mass drug administration campaigns when the benefit outweighs the risk[4].

What are the market projections for BILTRICIDE?

The global anthelmintics market, including BILTRICIDE, is expected to grow significantly, reaching USD 5435.60 million by 2029 with a CAGR of 8.42%[3].

Are there any concerns about resistance to BILTRICIDE?

While widespread clinical resistance has not occurred, there are reports of limited resistance in heavily infected populations, which could impact future efficacy[4].

Sources

1. European Medicines Agency, "New treatment for young children with parasitic disease schistosomiasis," December 15, 2023.
2. RxList, "Biltricide (Praziquantel): Side Effects, Uses, Dosage, Interactions."
3. Data Bridge Market Research, "Global Anthelmintics Market – Industry Trends and Forecast to 2029."
4. Centers for Disease Control and Prevention, "Clinical Care of Schistosomiasis - CDC," March 4, 2024.
5. Oxford Academic, "Costs and Prescribing Patterns of Anthelmintics in the United States," February 14, 2022.