JW Pharmaceutical has entered the data acquisition phase for its in-house developed gout treatment, Epaminurad (project name URC102), as it nears commercialization. With global Phase 3 clinical trials approaching completion, the company has initiated a separate clinical trial to demonstrate drug equivalence between South Korea and overseas manufacturing sites. Having finalized its U.S. patent registration, industry experts believe the company is well-positioned for entry into the global market.
Participant Recruitment Begins at Jeonbuk National University Hospital to Verify Manufacturing Site Differences
On Thursday, the Ministry of Food and Drug Safety announced that JW Pharmaceutical has officially begun recruiting participants for the Epaminurad clinical trial at Jeonbuk National University Hospital. This trial, approved on December 8 of last year, aims to prove the consistency of manufacturing quality – a crucial step in the new drug approval process.
The trial design specifies that participants will receive the clinical trial drug on an empty stomach in the morning, following a randomly assigned sequence.
The study will compare the absorption rates and safety profiles of domestically manufactured Epaminurad (test drug) against its overseas-manufactured counterpart (control drug).
Industry insiders view this clinical design as a strategic move to enable flexible management of domestic and overseas production volumes in preparation for global market entry.
Global Phase 3 Trials Progress Smoothly: Aiming for Best-in-Class Safety Profile
The global Phase 3 clinical trials, the cornerstone of Epaminurad’s development, are progressing well. These trials involve 588 gout patients across five countries: South Korea, Taiwan, Thailand, Singapore, and Malaysia. This phase marks the final stretch of a three-year journey that began after receiving approval from the Ministry of Food and Drug Safety in November 2022.
The trial is designed as a non-inferiority study, comparing Epaminurad’s blood uric acid reduction effects and safety profile against Febuxostat, the current market leader in gout treatments.
The global gout treatment market faces significant unmet medical needs due to safety limitations of existing medications, which often have relatively weak efficacy and potential side effects such as skin rashes.
Epaminurad successfully met all primary and secondary endpoints in its Phase 2b trials, demonstrating excellent results for key safety indicators, including cardiovascular side effects and liver toxicity.
JW Pharmaceutical is developing Epaminurad as a uric acid excretion promoter that selectively inhibits URAT1. This medication targets hyperuricemia and gout, with the potential to overcome existing drug limitations, positioning it as a best-in-class candidate.
U.S. Patent Barrier Established: Securing Exclusive Market Position Until 2038
On December 3, JW Pharmaceutical secured a patent from the U.S. Patent and Trademark Office (USPTO) for Epaminurad’s dosage and usage. This patent, combined with the substance patent, is expected to create a formidable barrier against competitor market entry.
The patent acquisition extends Epaminurad’s exclusive sales period in the U.S. market from September 2029 to 2038. The patent has been registered in 18 countries, including South Korea, with reviews ongoing in major markets such as Europe, Japan, and China.
This patent strengthens JW Pharmaceutical’s position in future technology transfer negotiations. The company previously demonstrated market potential by transferring development and sales rights to China’s Simcere Pharmaceutical for the Chinese market in 2019.
According to global market research firm Grand View Research, the global gout treatment market was valued at approximately 10 trillion KRW (about 6.9 million USD) last year. The prevalence of gout is reportedly rising rapidly due to aging populations and changing dietary habits.
A pharmaceutical industry insider commented that the initiation of the clinical trial at Jeonbuk National University Hospital appears to be a proactive move to address potential production site issues that could arise during global commercialization. Securing equivalence data for domestic and overseas production could provide a competitive edge in global supply contracts upon product approval.