Shionogi & Co., Ltd.
Approval Obtained for Domestic Manufacturing and Marketing of Depression Treatment Drug ‘Zavege® Capsules 30mg’
Shionogi & Co., Ltd. has obtained domestic manufacturing and marketing approval for the depression treatment drug 'Zavege® Capsules 30mg' in Japan and has started market launch as a novel mechanism of action treatment with rapid efficacy.
Key Figures
- Product/Service Name: Zavege® Capsules 30mg
- Launch/Start Date: December 2025
- Target Market: Domestic Depression Patient Market in Japan
- Development Stage: Manufacturing and Marketing Approval Obtained (Commercialization)
AI要約
Overview of Products and Services
Shionogi & Co., Ltd. obtained manufacturing and marketing approval in Japan on December 22, 2025, for the depression treatment drug 'Zavege® 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.
Market Impact and Outlook
Conventional antidepressants often require several weeks to manifest effects, creating a high demand for treatments with rapid onset. 'Zavege®' 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.
