Shionogi Clinical Trials in the U.S.

As part of our commitment to addressing unmet medical needs, Shionogi and collaborating organizations are currently enrolling or preparing to enroll participants in clinical trials for infectious diseases, neurology/CNS, metabolic disorders and oncology.

Infectious Disease

SCORPIO-HR (ClinicalTrials.gov Identifier: NCT05305547) is a global Phase 3 clinical trial for non-hospitalized, symptomatic mild-to-moderate COVID-19 patients who have tested positive for SARS-CoV-2, regardless of risk factors or vaccination status.
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.

Neurology/CNS

Study 204 (ClinicalTrials.gov Identifier: NCT05163808) is a randomized, double-blind, placebo-controlled Phase 2b/3 study that that includes cognitive and safety assessments of zatolimast 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.

Acute Ischemic Stroke

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.

Metabolic Disorders

ClinicalTrials.gov Identifier: NCT06106334 is a crossover, Phase 1, open-label, single-arm study to investigate the effect of itraconazole on the pharmacokinetics of S-309309 in healthy male and female participants.

Oncology

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.