Shionogi Clinical Trials in the U.S.

STRIVE (ClinicalTrials.gov Identifier: NCT05605093) is an investigator-initiated research study, evaluating the safety and efficacy of ensitrelvir, given in addition to standard of care, for hospitalized patients with COVID-19 as part of the new Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE) platform protocol.

SCORPIO-PEP (ClinicalTrials.gov Identifier: NCT05897541) is a global Phase 3 clinical trial evaluating the safety and efficacy of ensitrelvir for the prevention of symptomatic SARS-CoV-2 infection in study participants exposed to household contacts who are symptomatic and tested positive for SARS-CoV-2. A participant website is also available.

Pediatric Ensitrelvir Trial is a Phase 3 clinical trial evaluating the safety and efficacy of ensitrelvir for children aged six to 11 years old in Japan.

ClinicalTrials.gov Identifier: NCT04215991 is a global Phase 2 study assessing the safety, tolerability and pharmacokinetics of cefiderocol in hospitalized pediatric patients aged 3 months to less than 18 years with suspected or confirmed aerobic Gram-negative bacterial infections.

ClinicalTrials.gov Identifier: NCT06086626 is a Phase 2 study assessing the pharmacokinetics, safety and tolerability of cefiderocol in hospitalized pediatric patients from birth to less than 3 months of age with suspected or confirmed aerobic Gram-negative bacterial infections.

ClinicalTrials.gov Identifier: NCT06079775 is a Phase 1, randomized, double-blind, controlled, drug-drug interaction and multiple-dose pharmacokinetics and safety study of xeruborbactam oral prodrug (QPX7831) in combination with ceftibuten in healthy adult participants.

Study 204 (ClinicalTrials.gov Identifier: NCT05163808) is a randomized, double-blind, placebo-controlled Phase 2b/3 study that includes cognitive and safety assessments of zatolmilast in adolescent males ages 9-17 with Fragile X syndrome.

Study 301 (ClinicalTrials.gov Identifier: NCT05358886) is a randomized, double-blind, placebo-controlled Phase 2b/3 study that includes cognitive and safety assessments of zatolmilast in adult males ages 18-45 with Fragile X syndrome.

Study 302 (ClinicalTrials.gov Identifier: NCT05367960) is an open-label extension study evaluating safety, available to participants with Fragile X syndrome after completing Study 204 or Study 301.

REvive (ClinicalTrials.gov Identifier: NCT05953480) is a randomized, double-blind, Phase 2b study evaluating the safety and efficacy of redasemtide in adult participants with acute ischemic stroke.

ClinicalTrials.gov Identifier: NCT05925114 is a randomized, double-blind, placebo-controlled Phase 2 study to assess the safety and efficacy of S-309309 in obese adults.

aCCeleR8-001 (ClinicalTrials.gov Identifier: NCT05101070) is a Phase 1b/2, multicenter, open-label study of S-531011 as monotherapy and in combination with an immune checkpoint inhibitor in participants with locally advanced or metastatic solid tumors.