OSAKA, Japan, January, 20, 2022 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President and CEO: Isao Teshirogi, Ph.D.; hereafter "Shionogi") announced that Shionogi has begun consultation with Pharmaceuticals and Medical Devices Agency (PMDA) on how to submit the clinical trial results of S-217622, an oraly administered antiviral drug for COVID-19, from today.
As expressed in the related notifications1, 2, Shionogi has been consulting with PMDA from the early stages of S-217622 development. Shionogi has already been submitting non-clinical and manufacturing/CMC* data, and today, Shionogi submitted the Phase 1 clinical trials data and initiated to discuss how to submit the Phase 2/3 clinical trial data. In the Phase 2a part of the Phase 2/3 clinical trials, antiviral effects have been confirmed, and Shionogi will continue to submit clinical trial data sequentially, as it is obtained. We will continue to consult closely with the Ministry of Health, Labor and Welfare, PMDA and other organizations regarding future aspects of the submission timing.
*CMC: Chemistry Manufacturing and Control
Shionogi is committed to “Protect people worldwide from the threat of infectious diseases” as our key focus. We are not only pursuing the research and development of therapeutics, but are also working towards total care for infectious diseases, through awareness building, epidemiologic monitoring, prevention, diagnosis, and addressing exacerbations, as well as the treating the infection itself. As SARS-CoV-2 continues to have a major impact on people’s lives and to represent a global threat, we will seek to contribute to re-establishing the safety and security of society by developing new products and services to address this pandemic, and will keep all stakeholders informed regarding the progress of our efforts.
S-217622, a therapeutic drug for COVID-19, is a 3CL protease inhibitor created through joint research between Hokkaido University and Shionogi. SARS-CoV-2 has an enzyme called 3CL protease, which is essential for the replication of the virus. S-217622 suppresses the replication of SARS-CoV-2 by selectively inhibiting 3CL protease. Phase 2b/3 Part of a domestic Phase 2/3 clinical trials is currently underway in mild, moderate, or asymptomatic COVID-19 patients in January 20223, 4.
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Notice Regarding the Initiation of a Phase 2/3 Clinical Trial for a COVID-19 Therapeutic Agent in Japan
Shionogi Announces Commitment to Fight COVID-19
Our efforts against COVID-19 are updated on our website as needed. A considerable amount of valuable information on COVID-19 from other websites is also summarized on this page, so please use it for reference: SHIONOGI website