JW Jungwoo, Gout Treatment New Drug 'Epaminurad' Receives Phase 3 Approval in Taiwan

First Case of Overseas Phase 3 Approval
IND Applications Submitted in Singapore, Thailand, and Malaysia

JW Pharmaceutical announced on the 18th that it has received approval for the clinical phase 3 trial plan (IND) for the gout treatment drug 'Epaminurad' from the Taiwan Food and Drug Administration (TFDA). This is the first time Epaminurad has received approval for a phase 3 clinical trial overseas.

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

Epaminurad, being developed as an oral medication, is a uric acid excretion promoter that works by inhibiting URAT1 (uric acid transporter-1). It is a promising new drug candidate effective for gout caused by hyperuricemia, a condition characterized by abnormally high uric acid levels in the blood.

Following this IND approval, JW Pharmaceutical will evaluate the efficacy (blood uric acid reduction effect) and safety of Epaminurad compared to febuxostat in gout patients in Taiwan.

JW Pharmaceutical plans to conduct phase 3 clinical trials of Epaminurad involving a total of 588 gout patients across five Asian countries, including Korea. To this end, in addition to Singapore and Thailand in July, the company also applied for IND approval from the Malaysian health authorities at the end of August. Currently, patient recruitment for phase 3 clinical trials is underway domestically, with patient enrollment and dosing having started since March.

Gout is classified into 'overproduction type' gout, where uric acid is produced in excess compared to normal individuals, and 'underexcretion type' gout, where uric acid excretion is impaired. While drugs that reduce uric acid production are already available, treatments that promote uric acid excretion for underexcretion type gout are not actively prescribed despite many patients, due to safety concerns regarding the kidneys and liver, according to the company.

In this context, JW Pharmaceutical explained that Epaminurad met both primary and secondary efficacy endpoints in the domestic phase 2b clinical trial completed in March 2021, confirming excellent safety and tolerability.

JW Pharmaceutical is pursuing global licensing out while conducting Asia-centered phase 3 clinical trials of Epaminurad. In 2019, the company licensed development and sales rights for China, Hong Kong, and Macau to China’s Simcere Pharmaceutical.

A JW Pharmaceutical official stated, "The approval in Taiwan is meaningful as the phase 3 clinical trial protocol for Epaminurad, designed independently, met the stringent overseas standards," adding, "Given the significant unmet needs in the global gout treatment market, we aim to develop Epaminurad as the best-in-class new drug in its category."

Meanwhile, according to the global market research firm Grand View Research, the global gout treatment market, currently valued at approximately 3 trillion KRW, is expected to grow to about 10 trillion KRW by 2025.

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