Announced details
Post-exposure prophylaxis of COVID-19. Prophylactic administration to household members or cohabitants of patients who have developed COVID-19.
The risk of developing COVID-19 through day 10 after administration was reduced by 67% versus the placebo group. The incidence of adverse events was similar in both groups.
Primary analysis population: 2,041 household contacts confirmed to be negative for SARS-CoV-2. Cumulative usage is not disclosed.
Shionogi Inc. is our U.S. group company. The FDA is the regulatory authority that granted the approval.
Shionogi Inc. is Shionogi's U.S. group company. The U.S. Food and Drug Administration (FDA) is the U.S. pharmaceutical regulatory authority. Other details, including location, representative, capital, year established and business activities, are not disclosed.
U.S. Food and Drug Administration (FDA)
Shionogi headquarters: Kita-ku, Osaka. The location of Shionogi Inc. is not disclosed.
The impact on consolidated results for the fiscal year ending March 2027 has been incorporated into the earnings forecasts announced on 12 May 2026.
The company does not address Contract Value / Offering price.
SCORPIO-PEP trial
The New England Journal of Medicine (published on 14 May 2026)
Vaccine Committee and COVID-19 Vaccine Task Force, Japanese Association for Infectious Diseases
| Item | Details |
|---|---|
| Names of Products / Services Covered | Ensitrelvir fumaric acid, Xocova® |
| Counterparty | U.S. Food and Drug Administration (FDA), Shionogi Inc. |
| Counterparty overview | Shionogi Inc. is Shionogi's U.S. group company. The U.S. Food and Drug Administration (FDA) is the U.S. pharmaceutical regulatory authority. Other details, including location, representative, capital, year established and business activities, are not disclosed. |
| Relationship with the Company | Shionogi Inc. is our U.S. group company. The FDA is the regulatory authority that granted the approval. |
| Applicable area | Post-exposure prophylaxis of COVID-19. Prophylactic administration to household members or cohabitants of patients who have developed COVID-19. |
| Awarding / certifying body | U.S. Food and Drug Administration (FDA) |
| Location | Shionogi headquarters: Kita-ku, Osaka. The location of Shionogi Inc. is not disclosed. |
| Quantitative Effects | The risk of developing COVID-19 through day 10 after administration was reduced by 67% versus the placebo group. The incidence of adverse events was similar in both groups. |
| Usage history | Primary analysis population: 2,041 household contacts confirmed to be negative for SARS-CoV-2. Cumulative usage is not disclosed. |
| Impact on Business Performance | The impact on consolidated results for the fiscal year ending March 2027 has been incorporated into the earnings forecasts announced on 12 May 2026. |
| Source | SCORPIO-PEP trial, The New England Journal of Medicine (published on 14 May 2026), Vaccine Committee and COVID-19 Vaccine Task Force, Japanese Association for Infectious Diseases |
Items this document does not state (7)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.Favorable results were obtained in the global Phase 3 post-exposure prophylaxis trial (SCORPIO-PEP trial).