Pipeline and Clinical Trials
We are committed to identifying unmet needs and harnessing the full potential of science to treat challenging human diseases. Our discoveries have led to the development of new treatments that have improved patients’ lives worldwide.
Shionogi has a long history of small molecule drug discovery. Our current pipeline includes projects across several therapeutic areas, including infectious diseases, rare diseases, acute ischemic stroke and oncology.
69% of our pipeline assets were developed in-house
U.S. Pipeline
These compounds and their uses are investigational and have not all been approved by the U.S. Food and Drug Administration. This information is presented only for purposes of providing a general overview and should not be construed as a recommendation for use of any product for unapproved uses.
Phase 1
Phase 2
Phase 3
Filing
Phase 4
Fetroja® (cefiderocol)
Zatolmilast
Redasemtide Trifluoracetate
Secutrelvir
S-337395
S-531011
S-606001
S-649228
S-054501
S-054502
Shionogi Clinical Trials in the U.S.
Shionogi and collaborating organizations are currently enrolling or preparing to enroll participants in the following clinical trials:
Infectious Disease
ClinicialTrials.gov Identifier: NCT07104162 is a Phase 1, open-label, single-dose study to determine the safety and pharmacokinetics of intravenous cefiderocol/xeruborbactam (S-649228) in participants with renal impairment.
ClinicalTrials.gov Identifier: NCT07093580 is a Phase 1 Study to investigate the safety, tolerability, and pharmacokinetics (PK) of single- and multiple-dose administration of a long-acting injectable S-892216 in healthy adult participants.
ClinicalTrials.gov Identifier: NCT07214571 is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, and efficacy of S-337395 in symptomatic nonhospitalized adults with respiratory syncytial virus who are at high risk of progression to severe disease.
Rare Disease
ClinicalTrials.gov Identifier: NCT07123155is 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.
Solid Tumors
ClinicalTrials.gov Identifier: NCT05101070 (aCCeleR8-001) 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.