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Research & Development

The Shionogi Group progresses its research and development activities with world-class productivity and with the objective of bringing pharmaceuticals needed by patients rapidly to global markets. The Group is also continuously pursuing access to external innovation through partnership and licensing opportunities with academia and venture companies, focused on future medical needs and novel products and technologies.

In research, the Shionogi Pharmaceutical Research Center (SPRC), the center of the Shionogi Group’s research functions, has continued to serve as a platform through which we have further strengthened the coordination and productivity of our drug discovery efforts , increasing the number of development candidates generated improving the success rate in transitioning from pre- clinical to clinical development. Looking ahead, our goal is to address the needs of a rapidly-aging society (extension of healthy life expectancy, support to return to productive life), focusing on infectious diseases and pain/CNS disorders as core therapeutic areas to create innovative medicines, complemented by efforts in obesity/geriatric metabolic disease and oncology/immunology, expected to offer opportunities for our future growth.

In development, we have now established bases for new product development in the United States, Europe, and Asia, in addition to Japan, and are concentrating on our effectiveness and speed in the development of our global medicines. Multiple new products created in SPRC have quickly progressed throughpreclinical development and then achieved clinical POC*. In addition, Shionogi has evolved into an organization capable of phase II and III clinical trials globally and of submitting NDA filings worldwide. Clear demonstrations of this capability include the US FDA approval of ospemifene, a treatment for postmenopausal vulvar and vaginal atrophy, and the approval of the anti-HIV treatment dolutegravir in many countries outside Japan.

The Shionogi Group will continue to work to achieve even more rapid and successful drug development in Japan, the United States, Europe and Asia, to provide best medicines required for patients globally as quickly as possible.

*POC (Proof of Concept): Proof in clinical trials that the compound’s concept (site and mechanism of action), including efficacy and safety, represents a reasonable approach to the treatment of the target disease in humans.

For reference: Drug Development Process:

For reference: Drug Development Process:

  • Phase I Clinical Trials: The initial phase of testing in humans. Confirms the drug’s pharmacokinetics (the rate of absorption in the body and the rate and method of elimination) and safety in healthy adults (certain drugs such as anti-cancer agents, however, are tested in patients).
  • Phase II Clinical Trials: Clinical trials to test efficacy and safety by administering the drug to a relatively small number of patients and to determine the effective dose regimen (dosage amount, dosing interval, etc.).
  • Phase III Clinical Trials: Clinical trials to test efficacy and safety by administering the drug to a larger number of patients. In these larger clinical trials, the drug’s advantage compared with a placebo or an existing drug is also investigated.

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