Crystalys Launches With $205M to Advance Dotinurad Globally, Already Approved in China by Eisai

Crystalys Therapeutics, a newly launched biotech backed by Novo Holdings, SR One and Catalys Pacific, announced its debut with a $205 million Series A financing. The company will advance dotinurad (URECE®), a selective urate transporter (URAT1) inhibitor for gout and hyperuricemia, into late-stage development in the U.S. and Europe.

Why Crystalys is Targeting the U.S. and Europe

Although dotinurad (URECE®) was launched in China by Eisai in July 2025 and has already been approved in China, Thailand, and the Philippines, Crystalys sees major unmet need in Western markets. Gout affects over 10 million patients in the U.S. and 17 million in Europe, with prevalence continuing to rise. Current standard-of-care therapies such as allopurinol and febuxostat are limited by tolerability issues, side effects, or insufficient efficacy in achieving target serum uric acid (sUA) levels.

Dotinurad offers a differentiated mechanism of action: it selectively inhibits URAT1 to reduce uric acid reabsorption in the kidney while minimizing off-target effects. In China, Phase 3 trial data demonstrated superior efficacy compared with febuxostat (73.6% of patients achieving sUA ≤6.0 mg/dL at 24 weeks vs. 38.1% for febuxostat). This evidence underpins Crystalys’ plan to bring the therapy to U.S. and European patients where options remain suboptimal.

Crystalys aims to leverage Japanese innovation (originating from Fuji Yakuhin, which discovered dotinurad) and combine it with Western regulatory and clinical execution to expand global reach. The company’s development strategy will focus on pivotal trials designed to align with FDA and EMA expectations.

Dotinurad Global Development and Commercialization

• Discovered by: Fuji Yakuhin
• Licensed to Eisai: Exclusive rights in China and ASEAN (Indonesia, Malaysia, Myanmar, Philippines, Thailand)
• Launched: China (July 2025), Thailand (Sept 2024), Philippines (Feb 2025)
• Planned expansion: U.S. and Europe under Crystalys development

Eisai retains rights across its licensed territories, while Crystalys’ financing will enable late-stage development and eventual commercialization in the U.S. and European markets.

Gout Burden and Market Outlook

Gout is estimated to affect over 23 million patients in China and is similarly rising in prevalence worldwide. If inadequately treated, gout can lead to joint damage, disability, and decreased quality of life. Market demand for safer, more effective urate-lowering therapies remains strong, particularly in the U.S. and EU, where new entrants could capture significant market share from established agents.

References:

• Eisai press release (July 2025): URECE launch in China
• Crystalys Therapeutics press release (Sept 2025)