Last updated: January 2, 2025
Introduction
Emodepside, originally developed as an antihelminthic veterinary drug for cats and dogs, is now being evaluated for its potential as a treatment for parasitic worm infections in humans. This article provides an update on the development of emodepside and its market projections.
Background and Origin
Emodepside was first developed by the Japanese pharmaceutical company Astellas and later commercialized by Bayer Animal Health. The Drugs for Neglected Diseases initiative (DNDi), in collaboration with Bayer AG, is currently advancing the clinical development of emodepside as a potential anti-parasitic macrofilaricidal treatment for onchocerciasis and other parasitic infections[1].
Current Phase of Drug Development
As of the latest updates, emodepside has successfully completed first-in-human Phase I studies, including both single ascending dose and multiple ascending dose studies in healthy volunteers in 2017 and 2018, respectively. These studies demonstrated that emodepside is orally bioavailable, and a tablet formulation has been developed for potential commercial use[1].
Phase II Clinical Trials
The Phase II proof-of-concept clinical trial, initiated in 2021, aims to investigate the safety and efficacy of emodepside in patients infected with Onchocerca volvulus. The trial is being conducted in Ghana and the Democratic Republic of the Congo. By April 2023, recruitment for the Phase II trial was finalized, and all study participants had completed treatment. Initial findings from this trial are expected to be released in the third quarter of 2024[1].
Efficacy and Safety Profile
Recent studies have confirmed the efficacy and safety of emodepside in treating parasitic worm infections. A Phase 2b trial published in The Lancet showed that emodepside had a strong efficacy and safety profile, particularly in treating hookworm infections. The study involved 293 participants infected with hookworms and demonstrated a cure rate of 96.6% with a single 30 mg dose of emodepside, compared to an 81.2% cure rate with the standard 400 mg dose of albendazole[3].
Notable Efficacy
Emodepside has shown notable efficacy in individuals with Trichuris trichiura and hookworm infections, positioning it as a promising candidate for pan-nematode treatment. This efficacy, combined with its safety profile, makes emodepside a potential game changer in the fight against helminthiasis[1][3].
Market Projections
The anthelmintic drugs market, which includes emodepside, is expected to grow significantly in the coming years. Here are some key market projections:
Market Size and Growth
The anthelmintic drugs market was valued at USD 2.62 billion in 2024 and is projected to reach USD 3.52 billion by 2031, growing at a CAGR of 4.13% from 2024 to 2031[2].
Segment Analysis
The market is categorized based on application (including benzimidazoles, macrocyclic lactones, pyrantel, and emodepside) and product (including veterinary medicine, parasitic worm treatment, human helminthiasis treatment, and preventive healthcare). The report also analyzes trends and factors influencing the market across various geographical regions[5].
Future Development and Trials
Following the positive outcomes of the Phase II trials, emodepside is expected to proceed to Phase III trials. These trials are planned to start in 2025 on Pemba Island and the Philippines, further evaluating the safety, long-term effectiveness, and optimal use of emodepside in treating parasitic worm infections[3].
Likelihood of Approval
GlobalData's report indicates that Phase II drugs for ancylostomiasis (hookworm infections) have a 100% phase transition success rate (PTSR) benchmark for progressing into Phase III. This suggests a high likelihood of approval for emodepside as it moves through the clinical trial phases[4].
Conclusion
Emodepside is a promising drug candidate with significant potential in the treatment of parasitic worm infections. Its strong efficacy and safety profile, as demonstrated in recent clinical trials, position it as a critical treatment option for both individual cases and as part of global deworming efforts. As the drug progresses through its development stages, it is likely to play a major role in the growing anthelmintic drugs market.
Key Takeaways
- Emodepside is being developed for human use after initial success as a veterinary drug.
- Phase II clinical trials have shown high efficacy and safety in treating hookworm and other parasitic infections.
- The drug is expected to proceed to Phase III trials in 2025.
- The anthelmintic drugs market is projected to grow significantly, with emodepside contributing to this growth.
- Emodepside has a high likelihood of approval based on historical drug development data.
FAQs
What is emodepside and how is it being developed?
Emodepside is an antihelminthic drug originally developed for veterinary use. It is now being evaluated for human use by DNDi in collaboration with Bayer AG to treat parasitic worm infections such as onchocerciasis and hookworm infections.
What are the current stages of emodepside's clinical development?
Emodepside has completed Phase I studies and is currently in Phase II clinical trials to investigate its safety and efficacy in patients infected with Onchocerca volvulus. Phase III trials are planned to start in 2025.
How effective is emodepside in treating parasitic worm infections?
Recent studies have shown that emodepside has a high efficacy in treating hookworm infections, with a cure rate of 96.6% compared to 81.2% with the standard treatment albendazole.
What is the market projection for the anthelmintic drugs market?
The anthelmintic drugs market is projected to grow from USD 2.62 billion in 2024 to USD 3.52 billion by 2031, at a CAGR of 4.13%.
What are the next steps in the development of emodepside?
Following the positive outcomes of Phase II trials, emodepside is expected to proceed to Phase III trials in 2025, which will be conducted on Pemba Island and the Philippines.
Sources
- DNDi: Emodepside - DNDi
- Verified Market Research: In-Depth Industry Outlook: Anthelmintic Drugs Market Size, Forecast
- Swiss TPH: New Study Confirms Efficacy of Emodepside Against Parasitic Worm Infections
- Pharmaceutical Technology: Emodepside by Bayer for Ancylostomiasis (Hookworm Infections)
- Market Research Intellect: Anthelmintic Drugs Market Size, Share & Growth Factors | Forecast