Nexera Pharma announced the submission of a manufacturing and marketing authorization application for the dual orexin receptor antagonist daridorexant in South Korea, aiming for approval in 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Corporation","jir_importance":"\u2605\u2605\u2605\u2606\u2606","jir_publication_date":"2026-03-04","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/03\/4565-20260304-01.pdf","jir_short_summary":"Nexera Pharma announced the submission of a manufacturing and marketing authorization application for the dual orexin receptor antagonist daridorexant in South Korea, aiming for approval in 2027.","jir_summary":"### Overview of the Manufacturing and Marketing Authorization Application in South Korea\nNexera Pharma Corporation has submitted a manufacturing and marketing authorization application to the Ministry of Food and Drug Safety (MFDS) of South Korea for daridorexant, a dual orexin receptor antagonist, for the treatment of patients with insomnia. In the Phase III clinical trial conducted in South Korea, the primary endpoint of total sleep time (sTST) and secondary endpoints of sleep latency (sLSO) and wake time after sleep onset (sWASO) were all achieved, and safety was comparable to the placebo group.\n\n### Market Background and Future Outlook\nIn South Korea, 15\u201325% of the adult population, approximately 6.5 to 11 million people, suffer from insomnia, and the number of chronic insomnia patients is increasing. Daridorexant is marketed in Japan under the brand name \"Quvivia\u00ae Tablets\" and is also sold in the United States, Canada, Europe, China, and Hong Kong. Approval in South Korea is targeted for 2027, and the company will provide updates on the review progress as appropriate. The impact of this application on consolidated earnings for the fiscal year ending December 2026 is considered minimal.","jir_financial_highlights":"Impact on consolidated earnings for the fiscal year ending December 2026: Minimal (Unknown)","jir_category":"","jir_hashtags":"#NexeraPharmaCorporation, #NewDrugApprovalApplication, #InsomniaTreatment, #Daridorexant, #JapaneseStocks","jir_key_figures":"Number of insomnia patients in South Korea: Approximately 6.5 to 11 million (15\u201325% of adult population)\nPrimary endpoint of Phase III trial: Significant improvement in total sleep time (sTST) (p<0.0001)\nSecondary endpoints of Phase III trial: Significant improvement in sleep latency (sLSO) and wake time after sleep onset (sWASO) (both p<0.0001)","jir_meta_title":"Nexera Pharma Announces Manufacturing and Marketing Authorization Application for Daridorexant in South Korea","jir_meta_description":"Nexera Pharma has submitted a manufacturing and marketing authorization application for the insomnia treatment drug daridorexant in South Korea, aiming for approval in 2027. The Phase III trial achieved primary endpoints and confirmed safety.","jir_og_title":"Nexera Pharma Announces Daridorexant Approval Application in South Korea","jir_og_description":"Nexera Pharma announces the manufacturing and marketing authorization application for the insomnia treatment drug daridorexant in South Korea, confirming efficacy and safety in the Phase III trial.","jir_og_image_url":"\/assets\/og\/company-general_ir.jpg","jir_chart_data_collection":"[]","ir_related_company":16880,"ir_release_date":"","ir_type":"","ir_is_new":false,"ir_document_url":"","jir_ir_type":"product_announcement","footnotes":""},"sector":[],"importance":[],"class_list":["post-33156","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n