Shionogi & Co., Ltd. has obtained domestic manufacturing and marketing approval for the depression treatment drug “Zazvey\u00ae Capsules 30mg” in Japan and has launched it in the market as a novel mechanism of action treatment with rapid 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Ltd.","jir_importance":"\u26054","jir_publication_date":"2025-12-22","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2025\/12\/4507-20251222-01.pdf","jir_short_summary":"Shionogi & Co., Ltd. has obtained domestic manufacturing and marketing approval for the depression treatment drug \"Zazvey\u00ae Capsules 30mg\" in Japan and has launched it in the market as a novel mechanism of action treatment with rapid onset.","jir_summary":"### Overview of Product and Service\n\"Zazvey\u00ae Capsules 30mg\" (generic name: Zulalon) is an oral depression treatment drug with a novel mechanism of action indicated for depression and depressive states. The domestic Phase 3 confirmatory trial demonstrated efficacy and safety with once-daily 30mg dosing over 14 days, showing rapid onset of symptom improvement from early after administration. Furthermore, efficacy and safety were confirmed upon re-administration following a drug-free interval of more than 6 weeks. Manufacturing and marketing approval in Japan was obtained on December 22, 2025.\n\n### Market Impact and Outlook\nThe estimated number of patients with depression in Japan is approximately 5 million. While conventional treatments often require several weeks to demonstrate efficacy, \"Zazvey\u00ae\" exhibits rapid onset, expected to improve depressive symptoms in a short period. This addresses significant unmet needs in the depression field and aims to transform the treatment paradigm. The impact on consolidated earnings for the fiscal year ending March 2026 is considered minimal, but efforts continue to ensure early patient access.","jir_financial_highlights":"Primary Endpoint Change from Baseline in HAM-D17 Total Score: Mean change in treatment group -7.43, placebo group -6.23 (Difference between groups -1.20; 95% confidence interval -2.32,-0.08; p<0.0365)\nImpact on Consolidated Earnings for Fiscal Year Ending March 2026: Minimal (Unknown)","jir_category":"Strategy\/Investment, Other","jir_hashtags":"#ShionogiCoLtd, #NewProduct, #JapaneseStocks","jir_key_figures":"Product\/Service Name: Zazvey\u00ae Capsules 30mg\nLaunch\/Start Date: December 2025\nTarget Market: Depression Treatment Drug Market\nDevelopment Stage: Manufacturing and Marketing Approval Obtained (Commercialization)","jir_meta_title":"Shionogi Obtains Domestic Manufacturing and Marketing Approval for Depression Treatment Drug Zazvey\u00ae Capsules 30mg","jir_meta_description":"Shionogi & Co., Ltd. has obtained domestic manufacturing and marketing approval in Japan for the depression treatment drug \"Zazvey\u00ae Capsules 30mg\" and will launch it as a novel mechanism of action treatment with rapid onset.","jir_og_title":"Shionogi Announces Approval for Depression Treatment Drug Zazvey\u00ae Capsules 30mg","jir_og_description":"Shionogi & Co., Ltd. has received manufacturing and marketing approval in Japan for the depression treatment drug \"Zazvey\u00ae Capsules 30mg,\" expected to be a novel mechanism of action treatment with rapid onset.","jir_og_image_url":"\/assets\/og\/company-product-announcement.jpg","jir_chart_data_collection":"[]","ir_related_company":6919,"ir_release_date":"","ir_type":"","ir_is_new":false,"ir_document_url":"","jir_ir_type":"product_announcement","footnotes":""},"sector":[],"importance":[],"class_list":["post-7566","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n