GSK’s Linerixibat Poised to Address Substantial Unmet Need for the Treatment of Pruritus Associated with Primary Biliary Cholangitis, According to Spherix Global Insights
Despite new market entrants in the form of Gilead’s Livdelzi and Ipsen’s Iqirvo, US gastroenterologists report nearly half of PBC patients suffer from moderate to severe pruritus, underscoring an existing unmet need.
EXTON, PA, July 17, 2025 (GLOBE NEWSWIRE) -- The treatment landscape for primary biliary cholangitis (PBC) has undergone a marked transformation over the past year, driven by the recent approvals of Gilead’s Livdelzi (seladelpar) and Ipsen’s Iqirvo (elafibranor). These additions to the therapeutic arsenal represent meaningful progress in disease management. However, new data from Spherix Global Insights’ Market Dynamix™: Primary Biliary Cholangitis and Primary Sclerosing Cholangitis 2025 (US) reveal that pruritus—a persistent and often debilitating symptom—continues to pose a significant unmet need for many patients living with PBC.
Among the 104 US gastroenterologists surveyed in the study, there was near-universal agreement on the importance of addressing pruritus—one of the most burdensome and distressing symptoms associated with PBC. Respondents estimated that approximately half of their PBC patients suffer from moderate to severe pruritus, a manifestation that significantly impacts quality of life and remains challenging to manage. As one specialist poignantly noted, “Patients with cholestatic liver disease will go to the world’s end to escape from pruritus and the insomnia it causes.”
Most gastroenterologists surveyed also acknowledged a substantial unmet need for therapies specifically targeting PBC-associated pruritus. While Livdelzi has demonstrated a significant reduction in itch symptoms after six months of treatment, only about half of respondents reported that their patients on Livdelzi required no additional intervention for pruritus. The need for effective symptom control is even more pronounced among patients receiving Iqirvo, further highlighting the gap in adequate pruritus management and the continued demand for novel therapeutic approaches.
In June, GSK announced that the FDA had accepted the New Drug Application (NDA) for its ileal bile acid transporter (IBAT) inhibitor, linerixibat, for the treatment of cholestatic pruritus in patients with PBC. The PDUFA target action date is set for March 24, 2026. Awareness of the IBAT class is already high among gastroenterologists, and most report they are likely to incorporate linerixibat into their treatment armamentarium if approved. As one specialist expressed, “The results seem promising with a significant symptom reduction among moderate to severe pruritus. However, abdominal pain and diarrhea side effects are somewhat concerning and may limit real-world use.” Another echoed the sentiment, noting, “It significantly improved symptoms of pruritus along with quality of life, which can be a challenging and quite debilitating symptom to treat.”
If approved, linerixibat could represent a meaningful advancement for patients struggling with PBC-related pruritus—a symptom that continues to profoundly impair quality of life and remains inadequately addressed by current therapies. Spherix Global Insights will continue to closely track emerging developments across the PBC treatment landscape and pipeline through its Market Dynamix™: Primary Biliary Cholangitis and Primary Sclerosing Cholangitis service.
Market Dynamix™ is an independent service providing analysis of markets anticipated to experience a paradigm shift within the next three to five years. Insights highlight market size, current treatment approaches, unmet needs, and expert opinions on the likely disruption introduced by pipeline agents.
About Spherix Global Insights
Spherix is a leading independent market intelligence and advisory firm that delivers commercial value to the global life sciences industry, across the brand lifecycle.
The seasoned team of Spherix experts provides an unbiased and holistic view of the landscape within rapidly evolving specialty markets, including dermatology, gastroenterology, rheumatology, nephrology, neurology, ophthalmology, and hematology. Spherix clients stay ahead of the curve with the perspective of the extensive Spherix Physician Community.
As a trusted advisor and industry thought leader, Spherix’s unparalleled market insights and advisory services empower clients to make better decisions and unlock opportunities for growth.
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NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and analysis addressed within are based on Spherix Global Insight’s analysis and do not imply a relationship with or endorsement of the companies or brands mentioned in this press release.
Jim Hickey, Gastroenterology Franchise Head Spherix Global Insights 4848794284 james.hickey@spherixglobalinsights.com
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