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During the congress, E-Posters will be accessible to all participants on the congress website 24/7, as well as in the E-poster stations in the congress center.
Preparing your E-Poster
Please review the E-Poster format requirements carefully when preparing your E-Poster. Should your E-Poster not meet the mentioned requirements, it may not be displayed as described above.
E-Poster Submission Deadline
Please prepare and upload your E-Poster no later than March 14, 2026 11.59PM CET. After this date, you will no longer be able to prepare and upload your E-poster and it will not be displayed and accessible on the congress website.
Please follow the instructions below to input your abstract title.
Abstract titles should be brief and reflect the content of the abstract.
Drug development in nephrology has long lagged behind that in other medical specialties; however, dedicated engagement and collaboration among patients, clinicians, industry, and regulators have accelerated nephrology drug development in recent years. We aimed to analyze the current state of regulatory approvals for nephrology drugs between Japan and the United States (US).
We identified new active substances and new indications for kidney diseases approved in Japan or the US between January 2015 and September 2025. Publicly available data were obtained from the websites of the Pharmaceuticals and Medical Devices Agency (PMDA)/Ministry of Health, Labour and Welfare (MHLW) and the U.S. Food and Drug Administration (FDA) as well as company press releases. We calculated cumulative approvals and categorized products as approved in both countries, US-only, or Japan-only. We then compared approval dates, assessed the utilization of expedited drug development programs, and described the characteristics of drugs unapproved in either jurisdiction.
The cumulative number of approvals was comparable between Japan (25 drugs across 29 indications) and the US (27 drugs across 27 indications). Among the 18 drugs approved in both countries, approvals tended to occur earlier in the US than in Japan, with a median difference of 1.3 years (interquartile range −0.1 to 2.9). Although the US led for most indications, approvals for renal anemia occurred 3.2 years earlier in Japan, largely reflecting earlier approvals of hypoxia-inducible factor prolyl-hydroxylase inhibitors based on two agents. Of the eight US-only approvals, 75% used FDA expedited programs, and half targeted IgA nephropathy relying on the accelerated approval pathway. Seven drugs spanning 11 indications were Japan-only; anemia and nephrotic syndrome each accounted for 3 of 11 indications (27%). In Japan, 45% of these Japan-only drugs utilized PMDA/MHLW expedited programs, yet none received conditional early approval. In addition, in the US, more than half of these Japan-only indications were reimbursed when used off-label.
US approvals generally preceded those in Japan; however, the magnitude and direction varied by indication, with Japan earlier for renal anemia and the US earlier for most other areas. Divergent use of expedited pathways and distinct reimbursement practices may affect development strategies in both countries.
