JW Jungwoo Pharmaceutical's Gout Treatment 'Epaminurad' Receives Phase 3 Approval in Thailand

Phase 3 Clinical Trials Conducted in Korea and Five Asian Countries

JW Pharmaceutical announced on the 21st that it received approval for the Phase 3 clinical trial plan (IND) for the gout treatment 'Epaminurad' from the Thailand Food and Drug Administration (FDA) on the 18th.

JW Choongwae Pharmaceutical Gwacheon Office Building Exterior.
[Photo by JW Choongwae Pharmaceutical]

This is the second time Epaminurad has received Phase 3 IND approval overseas, following Taiwan last month. JW Pharmaceutical has applied for INDs in five Asian countries, including South Korea, to conduct a Phase 3 clinical trial of Epaminurad involving a total of 588 gout patients. INDs have been approved in South Korea, Taiwan, and Thailand, and applications were submitted to the health authorities of Singapore and Malaysia in July and August, respectively. Patient enrollment and dosing began domestically in March.

With this IND approval, JW Pharmaceutical will be able to evaluate the efficacy (reduction of serum uric acid levels) and safety of Epaminurad in gout patients in Thailand as well.

Epaminurad, developed as an oral drug, is a uric acid excretion promoter that inhibits URAT1 (uric acid transporter-1). It is a promising new drug candidate effective for gout caused by hyperuricemia, an abnormally high concentration of uric acid in the blood. JW Pharmaceutical confirmed the tolerability and safety of Epaminurad in a domestic Phase 2b clinical trial completed in March 2021. Both primary and secondary efficacy endpoints were also met.

JW Pharmaceutical is also pursuing global license-out opportunities alongside the Phase 3 clinical trial of Epaminurad. In 2019, it licensed development and marketing rights for China, Hong Kong, and Macau to China's Simcere Pharmaceutical.

A JW Pharmaceutical official stated, "The Phase 3 clinical trial protocol for Epaminurad, designed in-house, continues to meet the clinical trial standards of overseas health authorities," adding, "We will proceed smoothly with the multinational Phase 3 clinical trial to develop it as the best-in-class new drug in the global gout treatment market."

This content was produced with the assistance of AI translation services.