ArticleBritish journal of clinical pharmacology2026
Effects of Renal and Hepatic Impairment on the Pharmacokinetics of Zilurgisertib.
Article in British journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05090891 (A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva), which is not on this map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
Who cites it
1 citing paper in PubMed.
- Effects of Renal and Hepatic Impairment on the Pharmacokinetics of Zilurgisertib.British journal of clinical pharmacology · 2026Article
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6 authors.
Funding
Abstract
aimSmall-molecule activin receptor-like kinase-2 inhibitor zilurgisertib (INCB000928) is under investigation in a pivotal trial for the treatment of fibrodysplasia ossificans progressiva (FOP), an ultrarare genetic condition. This analysis assessed effects of renal and hepatic impairment on zilurgisertib pharmacokinetics.
methodsTwo open-label, parallel-group studies were conducted. Participants with renal or hepatic impairment were matched with healthy controls and received a single 200-mg dose of zilurgisertib; those with end-stage renal disease (ESRD) received doses before and after haemodialysis. Plasma concentrations were quantified via validated assay; pharmacokinetic parameters were derived from non-compartmental analysis. Geometric mean ratios (GMRs) and 90% confidence intervals (CIs) for C
resultsCompared with matched controls, GMRs (90% CIs) for C
conclusionsZilurgisertib exposure was unchanged with mild renal or moderate hepatic impairment, but increased by 30%-70% with moderate or more severe renal impairment and by 25% with severe hepatic impairment. These findings, alongside the therapeutic index, to be defined by the ongoing pivotal FOP trial (NCT05090891), will guide dosing in these populations.
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