Shionogi & Co., Ltd. has obtained domestic manufacturing and marketing approval for the depression treatment drug ‘Zavege\u00ae Capsules 30mg’ in Japan and has started market launch 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\/4507-20251222-02.pdf","jir_short_summary":"Shionogi & Co., Ltd. has obtained domestic manufacturing and marketing approval for the depression treatment drug 'Zavege\u00ae Capsules 30mg' in Japan and has started market launch as a novel mechanism of action treatment with rapid efficacy.","jir_summary":"### Overview of Products and Services\nShionogi & Co., Ltd. obtained manufacturing and marketing approval in Japan on December 22, 2025, for the depression treatment drug 'Zavege\u00ae Capsules 30mg' (generic name: Zulanolone). This oral medication, administered at 30mg once daily for 14 days, features a novel mechanism of action and is expected to provide rapid improvement of depressive symptoms. Efficacy and safety have been confirmed through Phase 3 verification trials, with effectiveness also observed upon re-administration. The target market comprises depression patients in Japan, with an estimated patient population of approximately 5 million.\n\n### Market Impact and Outlook\nConventional antidepressants often require several weeks to manifest effects, creating a high demand for treatments with rapid onset. 'Zavege\u00ae' addresses these unmet needs in the depression field by enabling symptom improvement over a short period. Shionogi aims to drive a paradigm shift in depression treatment through this drug and contribute to reducing the social health burden by facilitating early patient access. The impact on performance for the fiscal year ending March 2026 is expected to be minimal.","jir_financial_highlights":"Primary Evaluation Item: Change from Baseline in HAM-D17 Total Score: Mean change in treatment group -7.43, placebo group -6.23 (Between-group difference -1.20; 95% confidence interval -2.32, -0.08; p<0.0365)\nImpact on Consolidated Results for the Fiscal Year Ending March 2026: Minimal (Unknown)","jir_category":"Strategy\/Investment, Other","jir_hashtags":"#ShionogiCoLtd, #NewProduct, #JapaneseStocks","jir_key_figures":"Product\/Service Name: Zavege\u00ae Capsules 30mg\nLaunch\/Start Date: December 2025\nTarget Market: Domestic Depression Patient Market in Japan\nDevelopment Stage: Manufacturing and Marketing Approval Obtained (Commercialization)","jir_meta_title":"Shionogi & Co., Ltd. Obtains Domestic Manufacturing and Marketing Approval for Depression Treatment Drug Zavege\u00ae Capsules 30mg","jir_meta_description":"Shionogi & Co., Ltd. has obtained domestic manufacturing and marketing approval for the depression treatment drug 'Zavege\u00ae Capsules 30mg' in Japan. The drug, characterized by a novel mechanism of action with rapid efficacy, will be offered starting December 2025.","jir_og_title":"Shionogi & Co., Ltd. Announces Approval for Depression Treatment Drug Zavege\u00ae Capsules 30mg","jir_og_description":"Shionogi & Co., Ltd. has obtained domestic manufacturing and marketing approval for the depression treatment drug 'Zavege\u00ae Capsules 30mg' and will launch it as a novel mechanism of action treatment with rapid efficacy.","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-8209","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n