A Phase 1a/1b study of GSK4771261 (NCT06734234) has been running since December 2024 in healthy participants and people with ADPKD, and moved to active-not-recruiting status in July 2026. It is GSK's first disclosed program in polycystic kidney disease, adding another large pharmaceutical company to a pipeline that now includes Novartis, AstraZeneca, Vertex, AbbVie/Calico and Otsuka.
The randomized, double-blind, placebo-controlled study enrolls 86 participants across 23 sites in the United States, Canada, the United Kingdom, Germany, France, Spain, Belgium and the Netherlands. Part A tests single ascending doses in healthy volunteers; Part B gives the drug to ADPKD patients, with blood and urine biomarker readouts alongside safety, pharmacokinetics and pharmacodynamics.
GSK has not disclosed the target or mechanism. The registry entry lists anti-drug antibody (immunogenicity) endpoints, which points to a biologic — an antibody or protein therapeutic — rather than an oral small molecule, though that is an inference from trial design rather than a company statement.
Study completion is estimated for July 2027. With enrollment closed, the next meaningful signal would be a conference presentation or a decision to advance into Phase 2 — worth watching at ASN Kidney Week and ERA.