Toray Industries, Inc. announced today the commencement of a clinical trial in Europe for RAPROS®, an oral treatment designed for chronic kidney disease (CKD) in cats.
Feline CKD is a progressive condition that deteriorates kidney function, causing symptoms like appetite loss and weight reduction. Without proper treatment, the mortality risk escalates significantly. Existing treatments have long been inadequate. In 2017, Toray received approval in Japan to manufacture and market RAPROS®, with distribution managed by Kyoritsu Seiyaku Corporation. This was the first veterinary drug approved to decelerate kidney function decline. By the fiscal year ending March 31, 2023, RAPROS® dominated approximately 70% of Japan’s market for veterinary CKD treatments by value, achieving an estimated compound annual growth rate (CAGR) of 20% from 2017 to 2022.
The new clinical trial in Europe aims to support the application for marketing authorization on the continent. This randomized, placebo-controlled trial will involve 300 cats with CKD to assess the safety and efficacy of RAPROS®. Toray initiated the trial following consultations with the Committee for Veterinary Medicinal Products (CVMP) of the European Medicines Agency (EMA) and securing approvals from various European countries. The company plans to complete the trial and apply for marketing authorization in Europe by the end of 2026, with parallel development efforts in regions such as the USA and China.
Toray is dedicated to advancing veterinary medicine by introducing innovative treatments that improve the lives of pets and their owners worldwide.
Notes
- Source: Fuji Keizai Group, First data edition of “Directory of competition analyses of the veterinary drug and noteworthy disease markets and the latest market trends.”
- Placebo: In clinical trials, a placebo looks and tastes like the actual drug but contains no active ingredient. Animals are randomly assigned to either the placebo or drug group to prevent bias, a method considered highly effective for evaluating drug impacts.
RAPROS® Profile (as approved in Japan)
- Ingredients and Quantity: Each tablet contains 55 µg of beraprost sodium.
- Dosage and Administration: Administer one tablet orally twice daily, in the morning and evening after meals.
- Indications: In cats, RAPROS® suppresses renal function decline and improves clinical symptoms in IRIS stages 2-3 chronic kidney disease.
