Shionogi completes Phase 1 pharmacokinetic study of oral S-892216 in renal impairment
The trial enrolled 24 participants across renal-function and hemodialysis cohorts to measure how kidney disease alters drug exposure, with results not yet posted.
Executive Summary
- Shionogi closed out a Phase 1 study designed to measure how kidney impairment, including dialysis dependence, changes the body's handling of its oral drug candidate.
- Pharmacokinetic data from renal-impairment studies typically determine whether a drug needs dose adjustment or contraindication in kidney patients, a standard step before broader clinical or regulatory use.
- The trial's core exposure measurements have not yet posted publicly, leaving the central question, whether impaired kidney function meaningfully alters drug levels, still open.
- The mechanism behind the drug is not established in available data, so this program cannot be placed against named mechanism peers; it sits within a Phase 1-heavy field of renal-impairment pharmacokinetic studies from other sponsors testing unrelated compounds.
The trial
The study, registered as NCT07217886, tested S-892216-PO, an oral formulation, in adults grouped by kidney function: normal renal function, mild, moderate, and severe impairment not on dialysis, and a separate cohort receiving hemodialysis at least three times weekly for six months or longer. It started October 16, 2025, and moved to Completed status as of the July 13, 2026 registry update, with a primary completion date of February 13, 2026. The design carried five experimental treatment arms and no comparator arm beyond the matched healthy-control group. 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 endpoints
The primary endpoints measure drug exposure: area under the plasma concentration-time curve (AUC0-last), maximum plasma concentration (Cmax), and, for the hemodialysis cohort specifically, the amount of drug recovered in dialysate and its concentration across the dialysis circuit. A secondary endpoint tracked treatment-emergent adverse events through Day 39. These are standard pharmacokinetic measures used to determine whether renal impairment or dialysis clearance changes drug levels enough to warrant a dose adjustment. No results have posted on ClinicalTrials.gov for any of these measures. NCT07217886A Study of S-892216-PO in Participants With Renal Impairment and Matched ControlsNCT07217886
Enrollment and status
The trial enrolled 24 participants, down from an original target of 40, with enrollment type shifting from Anticipated to Actual as the trial closed. For a non-randomized Phase 1 pharmacokinetic study organized into defined renal-function strata, filling each cohort to its clinically relevant threshold, rather than hitting a pre-set total, is the operating logic; the trial reached Completed status cleanly, with no post-completion changes to the registered endpoints. NCT07217886A Study of S-892216-PO in Participants With Renal Impairment and Matched ControlsNCT07217886
Competitive and regulatory frame
S-892216's target and mechanism are not established in available data, so no direct mechanism comparator can be named. The renal-impairment field otherwise shows a spread of Phase 1 programs from Pfizer, Incyte, Eli Lilly, and Sun Pharmaceutical Industries, among others, but each tests a distinct small-molecule or peptide mechanism unrelated to S-892216, making them contextual neighbors sharing only indication and phase, not direct comparators. No FDA designation events are on record for S-892216 in this indication. Shionogi's broader trial portfolio shows a 92% completion rate across 63 trials with a track record, context for execution reliability rather than a signal specific to this asset.
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.