GSK’s Linerixibat Gains NMPA Priority Review in China for Itch in Rare Liver Disease

GSK plc has achieved a key milestone in addressing a debilitating symptom of primary biliary cholangitis (PBC), a rare autoimmune liver disease. China’s National Medical Products Administration (NMPA) has accepted the company’s new drug application for linerixibat an investigational inhibitor of the ileal bile acid transporter (IBAT) and granted it priority review status.

This fast-tracks the potential approval of linerixibat specifically for treating cholestatic pruritus, the intense, relentless internal itching that plagues many PBC patients.

Breakthrough from GLISTEN Phase III Trial

The filing rests on robust data from the GLISTEN phase III trial (NCT04950127), unveiled last year at the European Association for the Study of the Liver (EASL) Congress. The study met its primary endpoint and key secondary measures, showing linerixibat delivered rapid, significant, and lasting relief from cholestatic pruritus compared to placebo.

It also improved itch-related sleep disruptions, a common torment for patients. Linerixibat’s safety profile aligned with prior trials, reflecting its IBAT inhibition mechanism, which blocks bile acid reabsorption in the gut to lower circulating pruritus triggers.

In PBC, the liver’s bile ducts inflame and scar, causing bile acids to build up in the blood. These trigger severe itching via skin nerve activation. Linerixibat acts locally in the ileum (small intestine) to prevent bile acid recycling, slashing these mediators without broadly disrupting liver function offering a targeted fix where options like antihistamines or opioids often fall short.

The Heavy Toll of Cholestatic Pruritus in PBC

PBC affects roughly 280,000 people in China, striking mostly women and progressively damaging the liver. Up to 89% of patients endure cholestatic pruritus at some point, which disrupts sleep, erodes quality of life, and can drive extreme measures like liver transplantation even absent full liver failure.

Current treatments provide limited relief, leaving a critical unmet need. Globally, PBC impacts millions, underscoring linerixibat’s potential as a game-changer if approved.

Linerixibat has earned Orphan Drug Designation in the US, EU, and Japan for this indication, recognizing its role in a rare condition. Marketing applications are now under review by health authorities in the US, EU, UK, and Canada. The drug remains unapproved worldwide.

GSK’s Broader Push in Hepatology

This advances GSK’s expanding hepatology efforts, leveraging inflammation expertise and immune system insights. Beyond PBC pruritus, the company pipelines therapies for chronic hepatitis B and steatotic liver disease (SLD), including metabolic dysfunction-associated steatohepatitis (MASH) and alcohol-associated liver disease (ALD).

Priority review in China signals momentum, potentially bringing linerixibat to patients faster in a market with high PBC prevalence.

As GSK navigates these reviews, linerixibat exemplifies precision medicine for fibro-inflammatory liver woes, promising real symptom relief where it’s needed most.

References

Linerixibat accepted for priority review in China for cholestatic pruritus in patients with primary biliary cholangitis, 26 February 2026, Linerixibat accepted for priority review in China for cholestatic pruritus in patients with primary biliary cholangitis | GSK

GLISTEN phase III trial results show linerixibat significantly improves cholestatic pruritus (relentless itch) in primary biliary cholangitis (PBC), 08 May 2025, Linerixibat accepted for priority review in China for cholestatic pruritus in patients with primary biliary cholangitis | GSK

Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN), ClinicalTrials.gov ID NCT04950127, https://clinicaltrials.gov/study/NCT04950127