S-892216-Po
Renal Impairment
Phase I
Completed
A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls
Oct 14, 2025
―
Cefiderocol/Xeruborbactam
Bacterial Infections
Phase I
Completed
A Study to Investigate Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam in Participants With Renal Impairment
Jul 29, 2025
―
Bpn14770
Hepatic Impairment
Phase I
Completed
Phase 1 Study of BPN14770 in Participants With Hepatic Impairment and Healthy Controls
Jun 05, 2025
―
Bpn14770
Renal Impairment
Phase I
Completed
Study of BPN14770 in Participants With Severe Renal Impairment and Healthy Controls
Jun 02, 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
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 Ltd (SGIOF) have in its pipeline
SGIOF is currently developing the following drugs: S-606001, Ert, S-606001, Secutrelvir. These drug candidates are in various stages of clinical development as the company works toward FDA approval.