Nxera Pharma has secured an exclusive Lucerastat license for Japan and selected Asia Pacific markets, agreeing to pay Idorsia CHF 7 million upfront and contribute to a global Phase 3 program for the investigational Fabry disease treatment.
Lucerastat license terms
The agreement announced on October 28, 2026, gives Nxera exclusive development and commercialization rights in Japan, South Korea, Taiwan and selected other Asia Pacific markets, excluding China. Idorsia is eligible to receive royalties on net sales in the licensed territories.
Nxera exercised an option granted in July 2023 as part of its acquisition of Idorsia’s Asia Pacific operations outside China. It will also manage clinical development in Japan.
New studies target kidney disease
Idorsia has initiated the FAB-KLEAR study, a Phase 3 kidney biopsy trial designed to enroll 16 adult male patients. The broader program also includes a 74-patient study comparing lucerastat with standard-of-care enzyme replacement therapies on kidney function. Nxera will participate in the comparative study.
Fabry disease is an inherited condition in which a fatty substance called Gb3 accumulates in cells, damaging organs including the kidneys and heart. Lucerastat is an investigational oral therapy designed to reduce Gb3 production.
Earlier trial findings
The earlier Phase 3 MODIFY study did not meet its primary endpoint of reducing neuropathic pain. It did, however, show reductions in plasma and urinary Gb3 compared with placebo.
In an interim analysis of its long-term extension, treatment was associated with a slower rate of kidney function decline than in the period before enrollment. The new studies are intended to generate further evidence for registration.
Next milestone
The companies expect the Phase 3 program to support a regulatory filing as early as 2029.
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