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Shionogi & Co (4507) Drug Pipeline

Drug pipeline
Drug NameConditionStageStatusStudy NameTrial Start DateArticle
S-606001Pompe DiseasePhase INot Yet RecruitingA Study of S-606001 as Monotherapy in Participants With Late-onset Pompe Disease (LOPD)Aug 24, 2026
Ert, S-606001Pompe DiseasePhase IINot Yet RecruitingAn Extension Study of S-606001 in Participants With Late-onset Pompe Disease (LOPD)Jul 30, 2026
SecutrelvirSars-Cov-2Phase IIIRecruitingA Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe DiseaseJul 30, 2026
SecutrelvirCovid-19Phase IIIRecruitingStudy of Secutrelvir in Participants With COVID-19Jul 17, 2026
S-892216-PoRenal ImpairmentPhase ICompletedA Study of S-892216-PO in Participants With Renal Impairment and Matched ControlsOct 14, 2025―
S-337395Respiratory Syncytial Virus InfectionsPhase IIRecruitingA Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe DiseaseOct 08, 2025
Cefiderocol/XeruborbactamBacterial InfectionsPhase ICompletedA Study to Investigate Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam in Participants With Renal ImpairmentJul 29, 2025―
S-606001Pompe DiseasePhase IIRecruitingStudy of S-606001 as an Add-on to Enzyme Replacement Therapy (ERT) in Participants With Late-onset Pompe Disease (LOPD)Jul 25, 2025
S-892216-LaiHealthy ParticipantsPhase IRecruitingStudy of S-892216 Long-acting Injectable (LAI) in Healthy Adult ParticipantsJul 23, 2025―
Bpn14770Hepatic ImpairmentPhase ICompletedPhase 1 Study of BPN14770 in Participants With Hepatic Impairment and Healthy ControlsJun 05, 2025―

FAQ

What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases: a. Preclinical testing b. Phase 1 – Safety and dosage c. Phase 2 – Effectiveness and side effects d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Shionogi & Co (JP:4507) have in its pipeline
Shionogi & Co JP:4507 is currently developing the following drugs: S-606001, Ert, S-606001, Secutrelvir, S-892216-Po, S-337395, Cefiderocol/Xeruborbactam, S-892216-Lai, Bpn14770, Sivopixant, Acetazolamide, Sass-001, Redasemtide, S-217622, Naldemedine, Bevacizumab, Pembrolizumab, S-531011, Keytruda. These drug candidates are in various stages of clinical development as the company works toward FDA approval.