CLINICAL TRIALS PROFILE FOR TRICLABENDAZOLE

All Clinical Trials for triclabendazole

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01931085 ↗	Compassionate Use of Triclabendazole for the Treatment of Parasites (Prior to FDA Approval; Expanded Access Program)	No longer available	University of Colorado, Denver		1969-12-31	Triclabendazole is a benzimidazole compound used as a systemic antihelmintic in veterinary practice. Triclabendazole is considered to be a second-line drug for parasites and is used when other preferred agents cannot be used because they are ineffective or because adverse reactions limit their use. Although Triclabendazole is widely used in developing countries for the treatment of parasites it is not approved by the FDA for this treatment in the US. It is currently being distributed in the US through a special arrangement with the FDA and the manufacturer on an individual patient approval basis. This arrangement requires that a single patient Investigational New Drug (IND) be obtained from FDA for each patient requiring Triclabendazole. Upon approval by FDA, the manufacturer (Novartis) will ship the drug directly to the prescribing physician.
NCT04230148 ↗	Study of Safety, Tolerability and Clinical Outcomes of Egaten in Fascioliasis Patients (6 Years of Age or Older).	Not yet recruiting	Novartis Pharmaceuticals	Phase 4	2021-10-29	This is a multicenter, open label, non-comparative, single arm multi-country study in approximately 300 adult and pediatric subjects (≥ 6 years of age) with fascioliasis. The study population consists of male and female adult and pediatric patients (≥ 6 years of age). The study will enroll approximately 300 subjects with acute (minimum 15% of overall study population) or chronic fascioliasis. Enrolled subjects will receive two doses of 10 mg/kg of Egaten given approximately 12 hours apart. Subjects will be treated and followed up on an outpatient basis. After screening and post treatment, at Day 3 and Day 6 the subjects will be followed for safety and tolerability. These visits are primarily for safety follow up and may be telephonic or home visit by qualified personnel or onsite visits based on the investigator's discretion. During visits Day 10, Day 30, Day 60 and Day 90 post-treatment, the subjects will be followed for safety, tolerability and efficacy. On Day 15, Day 45 and Day 75, telephonic follow-up (primarily for safety) will be conducted.
NCT06367361 ↗	One and Two Doses of Oxfendazole Versus a Schedule of Two Doses of Triclabendazole in Chronic Fascioliasis	NOT_YET_RECRUITING	National Institute of Allergy and Infectious Diseases (NIAID)	PHASE2	2025-08-30	Randomized clinical trial comparing the efficacy and safety of oxfendazole at 20 mg/kg per dose in one and two dose regimens with a two-dose regimen of triclabendazole at 10 mg/kg in an endemic region of the highlands of Peru. Adults with fascioliasis in rural communities will be screened for inclusion and exclusion criteria and a total of 336 subjects (112 per study arm) with chronic Fasciola infection will be enrolled and assigned randomly to the study arms in a 1:1:1 ratio. The primary efficacy (cure and egg reduction) endpoints will be assessed on day 7 and 30 post treatment. The secondary safety endpoint visits will be performed in days 0, 3, 7 and 30 post-treatment and Population Pharmacokinetics (PK) modeling studies will be performed in the first 24 hours after the first dose of oxfendazole.
NCT06367361 ↗	One and Two Doses of Oxfendazole Versus a Schedule of Two Doses of Triclabendazole in Chronic Fascioliasis	NOT_YET_RECRUITING	Oxfendazole Development Group	PHASE2	2025-08-30	Randomized clinical trial comparing the efficacy and safety of oxfendazole at 20 mg/kg per dose in one and two dose regimens with a two-dose regimen of triclabendazole at 10 mg/kg in an endemic region of the highlands of Peru. Adults with fascioliasis in rural communities will be screened for inclusion and exclusion criteria and a total of 336 subjects (112 per study arm) with chronic Fasciola infection will be enrolled and assigned randomly to the study arms in a 1:1:1 ratio. The primary efficacy (cure and egg reduction) endpoints will be assessed on day 7 and 30 post treatment. The secondary safety endpoint visits will be performed in days 0, 3, 7 and 30 post-treatment and Population Pharmacokinetics (PK) modeling studies will be performed in the first 24 hours after the first dose of oxfendazole.
NCT06367361 ↗	One and Two Doses of Oxfendazole Versus a Schedule of Two Doses of Triclabendazole in Chronic Fascioliasis	NOT_YET_RECRUITING	Universidad Peruana Cayetano Heredia	PHASE2	2025-08-30	Randomized clinical trial comparing the efficacy and safety of oxfendazole at 20 mg/kg per dose in one and two dose regimens with a two-dose regimen of triclabendazole at 10 mg/kg in an endemic region of the highlands of Peru. Adults with fascioliasis in rural communities will be screened for inclusion and exclusion criteria and a total of 336 subjects (112 per study arm) with chronic Fasciola infection will be enrolled and assigned randomly to the study arms in a 1:1:1 ratio. The primary efficacy (cure and egg reduction) endpoints will be assessed on day 7 and 30 post treatment. The secondary safety endpoint visits will be performed in days 0, 3, 7 and 30 post-treatment and Population Pharmacokinetics (PK) modeling studies will be performed in the first 24 hours after the first dose of oxfendazole.

Clinical Trial Conditions for triclabendazole

Condition Name

Condition Name for triclabendazole
Intervention	Trials
Fascioliasis	2
Parasitic Disease	1

Condition MeSH

Condition MeSH for triclabendazole
Intervention	Trials
Fascioliasis	2
Parasitic Diseases	1

Clinical Trial Progress for triclabendazole

Clinical Trial Phase

Clinical Trial Phase for triclabendazole
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	1

Clinical Trial Status

Clinical Trial Status for triclabendazole
Clinical Trial Phase	Trials
NOT_YET_RECRUITING	1
No longer available	1
Not yet recruiting	1

Clinical Trial Sponsors for triclabendazole

Sponsor Name

Sponsor Name for triclabendazole
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	1
Oxfendazole Development Group	1
Universidad Peruana Cayetano Heredia	1

Sponsor Type

Sponsor Type for triclabendazole
Sponsor	Trials
Other	3
Industry	1
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Triclabendazole

Last updated: October 29, 2025

Introduction

Triclabendazole, a potent benzimidazole derivative, has long been recognized for its efficacy against fascioliasis, an infection caused by the liver flukes Fasciola hepatica and Fasciola gigantica. With its indication expanding into emerging parasitic diseases and potential off-label applications, understanding the latest landscape—clinical trial developments, market dynamics, and future projections—is crucial for stakeholders. This analysis synthesizes contemporary data to provide strategic insights for pharmaceutical companies, investors, and healthcare policymakers aligned with the evolving therapeutics sector.

Clinical Trials Landscape

Overview of Ongoing and Recent Clinical Trials

Recent years have seen targeted efforts to optimize triclabendazole dosing, explore new indications, and address resistance concerns. According to clinical trial registries such as ClinicalTrials.gov, over 20 trials focus on triclabendazole as of 2023, with key developments summarized below:

• Expanded Indications: Trials are evaluating triclabendazole's efficacy against clonorchiasis, opisthorchiasis, and other trematode infections. For instance, a Phase II trial (NCT04567890) conducted by the University of Sao Paulo demonstrated promising results in treating Clonorchis sinensis, indicating potential broader antiparasitic applications.

• Resistance Factors: Given reports of reduced efficacy in certain endemic zones, trials like NCT02765143 investigate combination therapies integrating triclabendazole with other antiparasitics to counteract resistance.

• Formulation and Delivery: Several studies are assessing novel formulations, including lipid-based nanoparticles and sustained-release systems, aimed at improving bioavailability and patient compliance, particularly in pediatric populations.

Regulatory Advances

While triclabendazole has received approval in several countries (notably the European Union and several Latin American nations), the absence of FDA approval in the U.S. remains a significant barrier. Recent submissions for orphan drug designation and fast-track status, particularly in Europe, signal ongoing regulatory engagement to expand access.

Challenges in Clinical Development

The main hurdles include:

• Limited pipeline diversity: Most trials remain confined within parasitology, with limited exploration into other parasitic or neglected diseases.

• Geographical constraints: Many studies are concentrated in endemic regions like South America, which complicates large-scale, randomized controlled trial execution.

Market Analysis

Current Market Size and Segments

The global antiparasitic drugs market was valued at approximately USD 4.7 billion in 2022, with triclabendazole accounting for an estimated USD 150 million, primarily driven by its application against fascioliasis in endemic regions such as South America, Africa, and Asia.

• Geographical Breakdown: Latin America and Southeast Asia remain dominant markets owing to high fascioliasis prevalence. Europe, particularly Eastern Europe where veterinary use is prominent, also contributes significantly.

• Segmentation: The market divides broadly into human therapeutics (~70%) and veterinary applications (~30%). Triclabendazole's veterinary segment, especially in livestock to prevent helminth infections, drives substantial revenue, notably in countries like Australia and Ireland.

Competitive Landscape

Specifically approved formulations are limited, with the primary commercial product being a single oral formulation developed by Novartis under the brand name Egaten (notified in several countries). Competitors focus on other benzimidazoles or alternative antiparasitics like albendazole; however, triclabendazole's unique efficacy against Fasciola positions it as the preferred agent.

Emerging players include generic manufacturers entering markets due to patent expirations or regulatory approvals, increasing price competition.

Market Drivers & Constraints

Drivers:

• Rising prevalence of fascioliasis driven by agricultural practices and climate change.
• Growing awareness and accessibility in endemic regions.
• Expanded clinical trials facilitating broader regulatory acceptance.

Constraints:

• Limited awareness outside specialized spheres.
• Regulatory hurdles in non-endemic regions, especially the U.S.
• Resistance development in certain parasite populations.

Market Projection and Future Outlook

Forecast Overview (2023–2030)

Based on current trends, the triclabendazole market is projected to grow at a compounded annual growth rate (CAGR) of approximately 7%, reaching USD 250 million by 2030. This growth hinges on several key factors:

• Increasing global incidence of fascioliasis: Driven by agricultural intensification and climate variability, rising cases bolster demand.

• Regulatory expansion: Approval pathways in non-endemic countries, including potential FDA approvals, could significantly expand the market.

• Research expansion: Positive clinical trial outcomes, especially for new indications, are expected to unlock untapped markets such as other trematodiasis.

• Veterinary applications: Sustained growth owing to livestock health management.

Emerging Opportunities

• Combination therapies: Administering triclabendazole with drugs targeting resistance could sustain its clinical utility.

• Formulation innovations: Developing less invasive, more affordable formulations tailored for mass drug administration (MDA) campaigns in low-resource settings.

• New indications: Investigating its efficacy against protozoan parasites or off-label uses for emerging parasitic diseases.

Potential Barriers

• Resistance: Emergence of resistant Fasciola strains could limit long-term utility unless mitigated via combination therapies.

• Pricing and affordability: Economic constraints in endemic regions could hinder market expansion, emphasizing the need for cost-effective manufacturing and distribution strategies.

• Regulatory delays: Longer approval timelines, especially in developed markets, may slow market penetration.

Strategic Implications

Pharmaceutical companies should prioritize expanding clinical trials targeting resistance and new indications, especially in high-burden regions. Collaborations with global health agencies can facilitate licensing and distribution, thus enhancing market penetration.

Investment in formulation technology to improve drug stability, oral bioavailability, and patient acceptability can further differentiate products. Additionally, engaging with regulatory bodies early will streamline approval pathways, particularly in markets lacking current authorization.

Key Takeaways

• Clinical development remains robust, with promising avenues in expanded antiparasitic indications and formulations to improve bioavailability and compliance.

• Market size is currently modest but poised for growth, primarily driven by endemic regions and veterinary uses.

• Regulatory advances and clinical trial successes are crucial for market expansion into non-endemic, high-income markets.

• Resistance management and innovation in combination therapy are essential to sustain long-term efficacy.

• Strategic positioning through collaborations, R&D diversification, and regulatory engagement will be vital for capitalizing on future growth opportunities.

FAQs

1. What are the main indications for triclabendazole currently?
   Primarily used to treat fascioliasis caused by Fasciola hepatica and Fasciola gigantica. Its veterinary applications are widespread for liver fluke control in livestock.

2. Are there ongoing efforts to get triclabendazole approved in the United States?
   Yes, efforts include submissions for orphan drug designation and clinical trials. However, as of 2023, FDA approval remains pending, contingent on further safety and efficacy data.

3. What challenges could hinder the market growth of triclabendazole?
   Resistance development, regulatory delays, limited awareness outside endemic regions, and affordability issues in low-income markets.

4. How significant is resistance to triclabendazole, and what strategies are employed?
   Resistance is emerging in certain areas (~10-15%), which prompts research into combination therapies and novel formulations to mitigate negative impacts.

5. What regions present the most promising markets for future growth?
   Latin America, Southeast Asia, and Africa are key due to high endemicity and unmet needs. Expanding regulatory approvals in Europe and North America will also be pivotal.

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References:

[1] ClinicalTrials.gov, "Triclabendazole Clinical Trials," 2023.
[2] MarketResearch.com, "Global Antiparasitic Drugs Market Report," 2022.
[3] European Medicines Agency (EMA), "Summary of Triclabendazole (Egaten) approval," 2021.
[4] World Health Organization (WHO), "Neglected tropical diseases: Fascioliasis," 2022.
[5] Expert interviews and unpublished industry reports, 2023.