GSK has reported positive outcomes from the randomised Phase III GLISTEN trial of the targeted inhibitor of ileal bile acid transporter (IBAT), linerixibat.
The therapy aims to treat adults with cholestatic pruritus (itch) and primary biliary cholangitis (PBC), an autoimmune liver condition.
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The trial met its primary endpoint, which was the change from baseline in monthly itch scores, demonstrating that the therapy significantly improved itch, compared to a placebo, over 24 weeks.
The placebo-controlled, double-blind trial was carried out in 238 PBC subjects with cholestatic pruritus. They were initially enrolled equally into active and placebo groups.
The primary analysis of the trial assessed the safety and efficacy of the therapy against a placebo. Subjects who had moderate to severe itch were enrolled in the trial.
In the trial, subjects were allowed to potentially move to part B after initial treatment with either linerixibat or a placebo.
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By GlobalDataKey secondary endpoints of the trial were also met, including rapid improvement in itch at week two, and improvements in itch-related sleep interference over the 24-week treatment period.
At week 24, 56% of subjects in the therapy group experienced a meaningful itch improvement, compared to 43% in the placebo group.
The safety profile of the therapy was found to be in line with earlier studies. As of now, linerixibat has not received approval for use in any country.
The global PBC trial concluded across 19 countries, including Japan, Europe, China, and the Americas.
Stable use of anti-itch therapy, as suggested by guidelines, was permitted during the trial.
GSK respiratory, immunology and inflammation research and development global head and senior vice-president Kaivan Khavandi said: “Relentless itch is present in the majority of patients with PBC and is a symptom that affects sleep, mental health, and quality of life.
“With linerixibat, we are one step closer to addressing the high unmet need of itch and its related sleep interference that are critically important to patients but historically under-treated.”
Linerixibat works by inhibiting the re-uptake of bile acids, thereby minimising the circulation of several pruritus mediators.
The therapy received orphan drug designation from the European Medicines Agency and the US Food and Drug Administration for treating cholestatic pruritus in PBC patients.
In March 2025, GSK announced that it is partnering with the UK Dementia Research Institute (UK DRI) and Health Data Research UK (HDR UK) to investigate whether GSK’s Shingrix (zoster vaccine recombinant) could minimise dementia risk.
