Phase 3 (VISIONARY) trial data for the IgA nephropathy treatment VOYXACT has been disclosed. Demonstrates a significant stabilization of eGFR over 24 months compared with placebo, withSafety profile comparable to placebo. Progress toward FDA sbLA submission in the U.S. continues.<\/p>\n","protected":false},"comment_status":"open","ping_status":"closed","template":"","meta":{"Ticker":"","DATE":"","longName":"","company_name_ja":"","fullTimeEmployees":0,"address":"","phone":"","website":"","industry":"","sector":"","regularMarketPrice":0,"financialCurrency":"","marketCap":0,"fiftyTwoWeekLow":0,"fiftyTwoWeekHigh":0,"epsTrailingTwelveMonths":0,"epsForward":0,"bookValue":0,"totalRevenue":0,"OperatingIncome":0,"operatingMargins":0,"NetIncome":0,"profitMargins":0,"ebitda":0,"trailingPE":0,"forwardPE":0,"priceToBook":0,"returnOnEquity":0,"recommendationMean":0,"recommendationKey":"","targetMeanPrice":0,"numberOfAnalystOpinions":0,"analyst_earnings_data":"","dividendRate":0,"dividendYield":0,"payoutRatio":0,"totalEsg":0,"environmentScore":0,"socialScore":0,"governanceScore":0,"title":"","providerPublishTime":"","link":"","longBusinessSummary":"","longBusinessSummary_ja":"","quarterly_revenue":0,"quarterly_net_income":0,"quarterly_operating_profit":0,"enterprise_value":0,"company_officer_1_name":"","company_officer_1_title":"","company_officer_2_name":"","company_officer_2_title":"","company_officer_3_name":"","company_officer_3_title":"","company_officer_4_name":"","company_officer_4_title":"","company_officer_5_name":"","company_officer_5_title":"","company_officers_update_time":"","get_dividend_history_year1":0,"get_dividend_history_year2":0,"get_dividend_history_year3":0,"get_dividend_history_year4":0,"get_dividend_history_year5":0,"get_dividend_history_year6":0,"get_dividend_history_year7":0,"get_dividend_history_year8":0,"get_dividend_history_year9":0,"get_dividend_history_year10":0,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"jir_stock_code":"4578","jir_company_name":"Otsuka Holdings Corporation","jir_importance":"\u2605\u2605\u2605\u2605\u2606","jir_publication_date":"2026-08-04","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/08\/4578-20260804-01.pdf","jir_short_summary":"Phase 3 (VISIONARY) trial data for the IgA nephropathy treatment VOYXACT has been disclosed. Demonstrates a significant stabilization of eGFR over 24 months compared with placebo, withSafety profile comparable to placebo. Progress toward FDA sbLA submission in the U.S. continues.","jir_summary":"### Section Heading\nOtsuka Holdings Co., Ltd. and its 100% subsidiary Otsuka Pharmaceutical Co., Ltd. disclose the phase 3 (VISIONARY) data for VOYXACT (sobeprenlimab), showing an improvement in the 24-month eGFR slope and achievement of kidney function stabilization. The safety profile is comparable to placebo, and progress toward sBLA submission to the U.S. FDA continues.\n\n### Second Section Heading\nThese data suggest efficacy as a disease-modifying therapy and will support future approval applications and regulatory reviews in various countries. It is positioned as a key milestone that will contribute to medium- to long-term corporate value enhancement.","jir_financial_highlights":"Unknown: Unknown (Unknown)","jir_category":"","jir_hashtags":"#OtsukaHoldings, #VOYXACT, #IgAN","jir_key_figures":"24-month eGFR slope: sobeprenlimab group +0.3 (95% CI: \u22120.4 to 0.9) mL\/min\/1.73 m\u00b2\/year\nPlacebo group: \u22124.2 (95% CI: \u22124.9 to \u22123.6) mL\/min\/1.73 m\u00b2\/year\nBetween-group difference: 4.5 (95% CI: 3.6 to 5.4) mL\/min\/1.73 m\u00b2\/year","jir_meta_title":"Otsuka Holdings IGAN treatment VOYXACT Phase 3 data release | eGFR stabilization, approvals proceeding","jir_meta_description":"Otsuka Holdings' VOYXACT (sobeprenlimab) phase 3 data released. Demonstrates 24-month eGFR stabilization with safety comparable to placebo. Milestones toward FDA sbLA review and future regulatory filings.","jir_og_title":"VOYXACT Phase 3 data release by Otsuka Holdings","jir_og_description":"Phase 3 data for VOYXACT released, showing kidney function stabilization and progress on regulatory submissions.","jir_og_image_url":"\/assets\/og\/company-general_ir.jpg","jir_chart_data_collection":"[]","ir_related_company":6875,"ir_release_date":"","ir_type":"","ir_is_new":false,"ir_document_url":"","jir_ir_type":"product_announcement","footnotes":""},"sector":[],"importance":[],"class_list":["post-93952","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n