GSK's Liver Disease Drug Linerixibat Approved in the U.S. for Cholestatic Pruritus in PBC; NDA Filed in China

(Source: Qiu Shi Medicine Society)

Local time on March 19, GSK（GSK）Announced that the U.S. FDA has approvedLinacibat（Linerixibat）Listed,For treatmentPrimary Biliary Cholangitis（PBC）Cholestatic Pruritus in Adult Patients. The press release pointed out that this isThe first drug approved in the U.S. to treat this indication,Represents an important milestone in the field of PBC pruritus treatment。

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PBC is a cholestatic liver disease in which the flow of bile in the liver is obstructed. Excessive bile acids produced in this cycle are considered to be the cause of cholestatic pruritus, and this internal itching sensation cannot be relieved by scratching.Itching may occur at any stage of the PBC course or after biochemical index control, and about 89% of PBC patients will experience itching of varying severity. First-line treatment for PBC can only control the condition in approximately 70% of patients but does not alleviate the severity or impact of the itching.

Linacibat（Linerixibat）It is an oral IBAT inhibitor that can reduce various pruritic mediators in the bloodstream by inhibiting bile acid reuptake.

This approval is based on the positive results of the Phase III clinical trial GLISTEN.GLISTEN isA Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial（NCT04950127）`, aimed to evaluate the ileal bile acid transporter`（IBAT）Targeted Inhibitor LinerixibatEfficacy and Safety in Treating Cholestatic Pruritus in PBC Patients. The primary endpoint is assessed using a Numerical Rating Scale. (NRS) CalculationChange in monthly pruritus score from baseline over 24 weeks。

GLISTEN StudyThe full data has been presented at the 2025 Annual Meeting of the European Association for the Study of the Liver (EASL).（EASL）Publicly announced in China. The results showed that the trial met its primary endpoint, with patients receiving treatment during the 24-week period.LinacibatPatients Treated（n=119）Compared with the placebo group（n=119）Significant improvement in itching symptoms. The least squares mean difference between the two groups was -0.72, as measured by the worst itching intensity on a 0-10 numerical rating scale, indicatingLinacibatHas the potential to treat persistent pruritus in PBC patients。

The trial also met multiple key secondary endpoints, including improvement in itch score at Week 2 and improvement in itch-related sleep interference score over 24 weeks, with results showing:

Rapid onset of itch relief, significant improvement over the placebo group at Week 2, with continued improvement throughout the trial period.

During the 24-week treatment cycle, compared with placebo,LinacibatSignificantly improved sleep disturbances caused by itching.

At Week 24,LinacibatGroup has56% of patients showed clinically significant improvement in itching scores.(WI-NRS reduction ≥3 points), while the placebo group was 43%.

In terms of safety,LinacibatThe safety profile is consistent with previous studies and the mechanism of IBAT inhibition,The most common adverse event was diarrhea.（61%）And abdominal pain（18%）`, both of which are mostly mild to moderate.`LinacibatThe proportion of the group discontinuing medication due to diarrhea was 4%, compared to less than 1% in the placebo group.

LinacibatMarketing applications are ongoing in the EU, the UK, Canada and China.March 9,GSK announced a licensing agreement, granting Alfasigma S.p.A.LinacibatThe global exclusive rights for development, production, and commercialization, the transaction is still ongoing.

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