{"url":"https://newsforagent.com/news/2026-10-28/nxera-pharma-licenses-lucerastat-idorsia","markdown_url":"https://newsforagent.com/news/2026-10-28/nxera-pharma-licenses-lucerastat-idorsia.md","title":"Nxera Pharma Licenses Lucerastat for CHF 7 Million","headline":"Nxera Pharma Exercises Option to License Idorsia's Lucerastat for Japan and Asia Pacific","description":"Nxera Pharma exercised its option to license Idorsia's oral Fabry disease therapy lucerastat for Japan and Asia Pacific, paying CHF 7 million upfront.","section":"Partnerships","published_at":"2026-10-28T07:53:51+00:00","modified_at":"2026-10-28T07:53:51+00:00","author":"News Desk","key_takeaways":["Nxera Pharma will pay Idorsia CHF 7 million upfront for exclusive rights to lucerastat in Japan, South Korea, Taiwan and selected Asia Pacific markets, excluding China.","Idorsia initiated the FAB-KLEAR pivotal Phase 3 study, a kidney biopsy study in 16 adult male patients, as part of a global program expected to support a regulatory filing as early as 2029.","Lucerastat is an investigational oral substrate reduction therapy with more than 400 patient-years of clinical experience, and Nxera will manage clinical development in Japan."],"companies":[{"name":"Nxera Pharma","is_primary":true,"profile_url":"https://akta.pro/company-profiles/000418w/nxera-pharma","website":"https://www.nxera.life"},{"name":"Idorsia","is_primary":false,"profile_url":"https://akta.pro/company-profiles/00009sm/idorsia","website":"https://www.idorsia.com"}],"source":{"publisher":"GlobeNewswire","title":"Nxera Pharma Secures Exclusive Rights to Fabry Disease Phase 3 Oral Therapy Candidate Lucerastat for Japan and Selected Asia Pacific Markets","url":"https://www.globenewswire.com/news-release/2026/10/28/3389900/0/en/nxera-pharma-secures-exclusive-rights-to-fabry-disease-phase-3-oral-therapy-candidate-lucerastat-for-japan-and-selected-asia-pacific-markets.html"},"other_sources":[],"tags":["Partnerships","Nxera Pharma","Idorsia"],"body_markdown":"Nxera Pharma exercised its option to license lucerastat from Idorsia for Japan, South Korea, Taiwan and selected other Asia Pacific markets, excluding China, paying CHF 7 million upfront. [GlobeNewswire](https://www.globenewswire.com/news-release/2026/10/28/3389900/0/en/nxera-pharma-secures-exclusive-rights-to-fabry-disease-phase-3-oral-therapy-candidate-lucerastat-for-japan-and-selected-asia-pacific-markets.html) reported the co-development and commercialization agreement on October 28, 2026.\n\n## Nxera's Lucerastat Rights and Phase 3 Role\n\n[Nxera Pharma](https://akta.pro/company-profiles/000418w/nxera-pharma) will hold exclusive rights to develop and commercialize lucerastat in its territory and will contribute to the global Phase 3 development program. Idorsia is eligible to receive royalties on net sales in the territory. Idorsia granted the option in July 2023 as part of Nxera's acquisition of Idorsia's Asia Pacific operations outside China.\n\nLucerastat is an investigational oral substrate reduction therapy designed to reduce production of Gb3, a fatty substance that builds up in cells and damages the kidneys, heart and nervous system in Fabry disease. In the 118-patient Phase 3 MODIFY study, lucerastat significantly reduced plasma and urinary Gb3 compared with placebo. In an interim analysis of the open-label extension, treatment was associated with a slower rate of kidney function decline compared with the two years before enrollment, with an eGFR slope of -1.64 on lucerastat versus -3.50 historical.\n\nIdorsia initiated FAB-KLEAR, a pivotal Phase 3 kidney biopsy study in 16 adult male patients, as part of a global program that also includes a 74-patient study comparing lucerastat with standard-of-care enzyme replacement therapies on kidney function. Nxera will take part in the comparative kidney function study and will manage clinical development in Japan. Christopher Cargill, President and CEO of Nxera Pharma, said: “The clinical evidence generated to date, together with the defined Phase 3 development program, gives us confidence in the potential of lucerastat for people living with Fabry disease.”\n\nAmer Joseph, Chief Medical Officer and Head of Global Clinical Development at [Idorsia](https://akta.pro/company-profiles/00009sm/idorsia), said: “While the primary endpoint of neuropathic pain reduction was not met, a subjective outcome that is proving difficult to reach in Fabry disease, lucerastat demonstrated robust and sustained biomarker reductions and a promising signal for slowing renal function decline in patients.”\n\n## Nxera's Recent Partnership Milestones\n\nAccording to akta.pro [company records](https://akta.pro/company-data), Nxera triggered a US$22.5 million milestone from Neurocrine Biosciences in April 2026 as the first patient was dosed in a Phase 2 trial of NBI-1117570 in schizophrenia. In May 2026, Nxera closed a licensing agreement and Series A financing with a newly formed GPCR-focused spin-out, granting worldwide rights outside Asia Pacific while retaining Japan and certain Asia Pacific territories, with up to US$275 million in milestones plus tiered royalties.\n\n## Nxera's Path to the Lucerastat Deal\n\nIn June 2026, Nxera achieved its fourth R&D milestone under its multi-target discovery collaboration with AbbVie targeting neurological diseases, resulting in a US$10 million payment, GlobeNewswire reported. In August 2026, Nxera reported first half GAAP earnings per share of ¥15.86 and revenue of ¥18.91 billion, a 25.3% year-over-year increase, according to Seeking Alpha. Also in August 2026, partner Neurocrine Biosciences received FDA IND acceptance for a Phase 2 study of NBI-1117567 for Alzheimer's cognition, Yahoo reported.\n\n## Lucerastat Filing Timeline\n\nThe global Phase 3 program is expected to support a regulatory filing as early as 2029. Nxera will release its third-quarter 2026 earnings and present operational highlights on October 30, 2026, with a results and R&D webinar at 5 p.m. JST, The future of trading reported.\n","publisher":{"name":"News for Agent","url":"https://newsforagent.com"}}