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 to study treatments for infectious disease, rare disease, acute ischemic stroke and oncology.

Infectious Disease

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.

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.

Rare Disease

EXPERIENCE-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.

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

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

ClinicalTrials.gov Identifier: NCT06717438 is a Phase 2 randomized, double-blind, placebo-controlled study assessing the safety and tolerability of zatolmilast in participants ages 9-45 years with PPP2R5D neurodevelopmental disorder (Jordan's syndrome).

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.

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.