GST-HG171 needs lower dosing in kidney disease as impairment raises drug exposure
A China-based renal-impairment study found GST-HG171 exposure rose with worsening kidney function, leading to modeling-based dose cuts for patients with impaired renal clearance.
Executive Summary
- A renal-impairment pharmacokinetic study found that reduced kidney function raised blood levels of GST-HG171 in a pattern that tracked the severity of impairment.
- Because the drug is cleared by the kidney when boosted with ritonavir, worsening renal function measurably slowed its clearance from the body.
- Modeling of the pharmacokinetic data supported lower doses for patients with impaired kidney function, extending the drug's use to a population that would otherwise risk higher exposure.
- The drug was generally tolerated across all renal function groups, though the study flagged a specific metabolic adverse effect to watch.
What the study tested
GST-HG171 is a 3C-like protease inhibitor (blocks a viral enzyme needed for replication) already approved in China for mild to moderate COVID-19. Because the drug is eliminated by the kidney when co-administered with ritonavir, a booster drug used to sustain CYP3A enzyme inhibition, its developer, Fujian Akeylink Biotechnology Co., Ltd., ran a trial to measure how impaired renal function changes its pharmacokinetics, safety and tolerability. The trial is registered as NCT06106126, a Not Applicable study, reflecting its pharmacokinetic design rather than a drug-development efficacy phase. Pharmacokinetics+1Pharmacokinetics, safety, and dose optimization of GST-HG171 in renal impairment: insights from physiologically based pharmacokinetic modeling.Jul 15, 2026Pharmacokinetics and Safety of GST-HG171 Tablets in Subjects With Impaired and Normal Renal FunctionNCT06106126
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
How it was done
The study enrolled 24 adult participants in three groups of eight: normal renal function, mild renal impairment (CKD stage 2), and moderate renal impairment (CKD stage 3). Each participant received ritonavir 100 mg at -12, 0, 12 and 24 hours, with a single 150 mg dose of GST-HG171 given at hour 0 to maintain CYP3A inhibition. The trial measured maximum plasma concentration (Cmax) as its primary endpoint and adverse events through Day 10 as a secondary endpoint. Analysts compared geometric least-squares mean ratios with 90% confidence intervals between the impaired and normal renal function groups, then used physiologically based pharmacokinetic modeling to translate the exposure data into dosing recommendations. Pharmacokinetics+1Pharmacokinetics, safety, and dose optimization of GST-HG171 in renal impairment: insights from physiologically based pharmacokinetic modeling.Jul 15, 2026Pharmacokinetics and Safety of GST-HG171 Tablets in Subjects With Impaired and Normal Renal FunctionNCT06106126
The exposure result
Mild renal impairment raised GST-HG171 exposure versus normal renal function, with geometric mean ratios of 118.15 for Cmax, 139.48 for AUC0-t and 138.46 for AUC0-infinity. Moderate impairment raised exposure further, to ratios of 131.81, 186.18 and 182.64 for the same three measures. Renal clearance of the drug fell 22.7% in the mild impairment group and 52% in the moderate impairment group, a decline that scaled with disease severity rather than plateauing. PharmacokineticsPharmacokinetics, safety, and dose optimization of GST-HG171 in renal impairment: insights from physiologically based pharmacokinetic modeling.Jul 15, 2026
Dosing and safety
Physiologically based modeling of these exposure differences supported a dose reduction to GST-HG171/ritonavir 100/100 mg twice daily for mild renal impairment and 50/100 mg twice daily for moderate renal impairment, each for five days. The drug was generally tolerated across all three groups, though the study flagged adverse reactions related to hypertriglyceridemia (elevated blood fats) as a finding to monitor. No results have been posted to the trial's ClinicalTrials.gov record, so the abstract is the source for these figures. Pharmacokinetics+1Pharmacokinetics, safety, and dose optimization of GST-HG171 in renal impairment: insights from physiologically based pharmacokinetic modeling.Jul 15, 2026Pharmacokinetics and Safety of GST-HG171 Tablets in Subjects With Impaired and Normal Renal FunctionNCT06106126
Where this sits
GST-HG171 has no active competitor in the Chronic Kidney Disease trial landscape that shares its mechanism as an antiviral protease inhibitor; the small-molecule programs active in chronic kidney disease target different pathways, including SGLT2 inhibitors such as AstraZeneca's dapagliflozin and Boehringer Ingelheim's empagliflozin, and mineralocorticoid receptor antagonists such as Bayer's finerenone. Those programs are chronic kidney disease treatments in their own right, while GST-HG171 is an antiviral being dose-adjusted for patients who happen to have impaired kidneys, so they answer a different clinical question rather than compete on the same endpoint.
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.