Shionogi completes Phase 1 renal-impairment PK study of S-892216
The trial enrolled 24 of a planned 40 participants and finished with pharmacokinetic data now due, testing how kidney function and dialysis affect drug clearance.
Executive Summary
- Shionogi's Phase 1 study testing how renal impairment and hemodialysis affect exposure to its oral drug candidate has finished enrollment and moved to Completed status, with the pharmacokinetic data itself still to come.
- The study closed with fewer participants than originally planned, a change that falls within the range regulators and sponsors typically expect for this kind of small, stratified renal-function study and does not by itself signal a design or execution problem.
- The trial's endpoints measure drug concentration and clearance across normal kidney function, three grades of impairment, and dialysis, the standard data package used to determine whether a dose adjustment is needed in patients with reduced renal function.
- The value of this catalyst sits entirely in the pharmacokinetic results the completed trial has not yet disclosed, which will determine whether S-892216 can be dosed the same way regardless of kidney function or needs a modified regimen.
The study
NCT07217886 tested oral S-892216 in adults with normal kidney function and across three grades of renal impairment, plus a separate group receiving hemodialysis at least three times weekly for six months or longer. The trial's four primary endpoints measure the area under the plasma concentration-time curve, maximum plasma concentration, and for the hemodialysis group, how much drug is recovered in the dialysate during a hemodialysis session. A single secondary endpoint tracks treatment-emergent adverse events from Day 1 through Day 39. This is the standard design regulators expect before a drug's label can address dosing in patients with impaired kidney function. NCT07217886A Study of S-892216-PO in Participants With Renal Impairment and Matched ControlsNCT07217886
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
The enrollment change
The registry now shows the trial completed with an actual enrollment of 24 participants, down from an originally anticipated 40. The primary completion date landed on February 13, 2026, matching the date the registry had most recently guided to before this update. The operational model that flags enrollment changes uses a threshold of 20% or more before calling a shift material; a small, stratified renal-function PK study enrolling to the level needed to fill its impairment cohorts, rather than to an efficacy-driven target, sits within that routine band. NCT07217886+1A Study of S-892216-PO in Participants With Renal Impairment and Matched ControlsNCT07217886A Study of S-892216-PO in Participants With Renal Impairment and Matched ControlsJul 13, 2026
Sponsor context
Shionogi Inc. has completed 58 of 63 prior trials with results tracked, a completion rate in the low-to-mid 90s across its broader portfolio, and the company's pipeline currently includes 5 recruiting trials, 3 active-not-recruiting, and one drug approved for marketing. The company has no prior terminated trial in renal impairment on record for this asset, and S-892216 has no other trial in the sponsor's active portfolio beyond this one.
The competitive field
Renal-impairment pharmacokinetic studies are common across sponsors developing drugs for other primary indications, and several other companies, including Pfizer, Incyte, and Eli Lilly, are running their own Phase 1 renal-impairment studies for unrelated molecules in the same indication label. None of these share S-892216's target or mechanism, since S-892216's target has not been characterized in available records, so no direct mechanistic comparator exists for this specific PK question. The informative comparison here is not competitive positioning but whether the exposure data show a need for dose adjustment in any of the impairment strata or the dialysis cohort.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.