Shionogi & Co., Ltd.
Regarding the Acquisition of Domestic Manufacturing and Marketing Approval for the Depression Treatment Drug “Zazvey® Capsules 30mg”
Shionogi & Co., Ltd. has obtained domestic manufacturing and marketing approval for the depression treatment drug "Zazvey® Capsules 30mg" in Japan and has launched it in the market as a novel mechanism of action treatment with rapid onset.
Key Figures
- Product/Service Name: Zazvey® Capsules 30mg
- Launch/Start Date: December 2025
- Target Market: Depression Treatment Drug Market
- Development Stage: Manufacturing and Marketing Approval Obtained (Commercialization)
AI要約
Overview of Product and Service
"Zazvey® 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.
Market Impact and Outlook
The estimated number of patients with depression in Japan is approximately 5 million. While conventional treatments often require several weeks to demonstrate efficacy, "Zazvey®" 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.
