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

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 (S-743229) in combination with ceftibuten in healthy adult participants.

ClinicalTrials.gov Identifier: NCT06547554 is a Phase 1, randomized, double-blind, placebo-controlled, drug-drug interaction, pharmacokinetics and safety study of cefiderocol in combination with xeruborbactam in healthy adult participants.

Rare Disease

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).

ClinicalTrials.gov Identifier: NCT07123155 is a Phase 2, multicenter, randomized, placebo-controlled, double-blind study to investigate the safety, pharmacodynamics, and preliminary efficacy of S-606001 as an add-on to enzyme replacement therapy in patients with late-onset Pompe disease.

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.