The expansion of the cholestatic pruritus market across the US will be driven by the introduction of innovative therapies, Linerixibat, Volixibat, and TH104, among others. Furthermore, the rising prevalence of cholestatic pruritus, driven by increased disease awareness, improved diagnostic capabilities, earlier detection of underlying liver disorders, and an aging population, will contribute to greater demand for effective treatments.

LAS VEGAS, Nov. 4, 2025 /PRNewswire/ -- DelveInsight's Cholestatic Pruritus Market Insights report includes a comprehensive understanding of current treatment practices, cholestatic pruritus emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into the US. 

Cholestatic Pruritus Market Summary

• The market size for cholestatic pruritus in the US was estimated at USD 300 million in 2024.
• Cholestatic pruritus posed a significant clinical burden across rare liver diseases in the US in 2024, with approximately 76,000 cases in PBC.
• The overall burden of PBC, PSC, PFIC, ALGS, and biliary atresia is expected to increase steadily from 2025 to 2034, reflecting growing recognition, earlier diagnosis, and the need for expanded therapeutic strategies.
• Leading cholestatic pruritus companies developing emerging therapies, such as GlaxoSmithKline, Mirum Pharmaceuticals, Tharimmune, and others, are developing new therapy for cholestatic pruritus that can be available in the cholestatic pruritus market in the coming years. 
• The promising cholestatic pruritus therapies in clinical trials include Linerixibat (GSK2330672), Volixibat, TH104 (nalmefene), and others.
• Estimates suggest that Linerixibat will generate approximately USD 840 million in the US by 2034.

Discover the cholestatic pruritus new treatment @ New Treatments for Cholestatic Pruritus

Key Factors Driving the Growth of the Cholestatic Pruritus Market 

PBC as the Leading Contributor to Disease Burden

Cholestatic pruritus posed a significant clinical burden across rare liver diseases in the US in 2024, with approximately 76K cases in PBC, followed by PSC, ALGS, biliary atresia, and PFIC. While prevalence varies by disease, PBC accounts for the largest share due to its higher occurrence in adults, whereas PFIC, ALGS, and biliary atresia remain comparatively rare.

Increased Disease and Physician Awareness

Education by professional societies, patient advocacy groups, and pharma outreach has raised clinician awareness of cholestatic pruritus as a treatable clinical problem, accelerating referrals and uptake of new treatments.

Active Mid and Late Stage Cholestatic Pruritus Clinical Trial Activity

Companies like GSK's Linerixibat, Mirum's Volixibat, and Tharimmune's TH104, among others, are involved in the development of Phase III and Phase II drugs.

Cholestatic Pruritus Market Analysis

Cholestatic pruritus management focuses on treating the underlying liver disorder while providing symptomatic relief. Initial therapy typically includes bile acid sequestrants such as cholestyramine and antihistamines for mild symptoms. In contrast, ursodeoxycholic acid (UDCA) is prescribed for conditions such as PBC and ICP, albeit with modest benefit for pruritus. Patients who do not respond to these first-line options may be treated with rifampicin, opioid antagonists, or selective serotonin reuptake inhibitors (SSRIs). Fibrates such as bezafibrate, along with PPAR agonists like seladelpar, have shown potential in improving both liver function and itch severity, though adverse effects require close monitoring. IBAT inhibitors, including LIVMARLI and BYLVAY, act by disrupting bile acid recirculation and have demonstrated significant efficacy in pediatric cholestatic diseases, with age-specific FDA approvals. However, their benefit varies across specific PFIC subtypes.

LIVMARLI received its first approval in September 2021 for treating cholestatic pruritus in patients with Alagille syndrome (ALGS) aged one year and older, followed by a March 2024 approval for PFIC in patients aged five years and older, with the label later expanded to include infants as young as 12 months. BYLVAY was initially approved in July 2021 for PFIC patients aged three months and older, and subsequently in June 2023 for cholestatic pruritus in ALGS patients aged 12 months and older.

Advanced treatment options include UVB phototherapy, extracorporeal liver support, and liver transplantation for patients with refractory pruritus. Observational studies reveal that conventional agents remain the mainstay, bile acid-binding resins are most frequently used for PSC-related itch. At the same time, antihistamines dominate in PBC, with rifampicin, sertraline, and other agents used less often. 

Meanwhile, new therapies such as linerixibat, volixibat, and TH-104 are being developed to target pruritus pathways specifically. Linerixibat achieved rapid and sustained itch improvement in the GLISTEN trial, with a PDUFA target date set for March 2026. Volixibat demonstrated significant reductions in itch intensity in Phase IIb VANTAGE (PBC) and VISTAS (PSC) studies, with topline data expected in Q2 2026.

To know more about cholestatic pruritus treatment options, visit @ Approved Cholestatic Pruritus Drugs

Cholestatic Pruritus Competitive Landscape

Some of the cholestatic pruritus drugs in clinical trials include GSK's Linerixibat, Mirum's Volixibat, and Tharimmune's TH104, and others. 

GSK's Linerixibat, an oral IBAT inhibitor, is being developed to treat cholestatic pruritus associated with primary biliary cholangitis (PBC), a rare autoimmune liver disorder. By blocking bile acid reuptake, it targets a key biological driver of pruritus. The therapy is also under evaluation in a long-term Phase III study to assess its safety and tolerability in PBC patients.

Results from the Phase III GLISTEN trial, reported in May 2025, showed rapid and sustained reductions in pruritus and improvements in sleep quality among patients with PBC. Linerixibat received Orphan Drug Designation (ODD) from the FDA in 2019, and GSK presented updated findings from the GLISTEN study at AASLD 2024, emphasizing its clinical promise in this indication.

Mirum's Volixibat, another oral and minimally absorbed IBAT inhibitor, is in development for adult cholestatic liver diseases, aiming to lower systemic and hepatic bile acid concentrations to alleviate related symptoms and complications. The drug is currently in Phase IIb evaluation for cholestatic pruritus through the VISTAS trial in primary sclerosing cholangitis (PSC) and the VANTAGE trial in PBC. Enrollment for VISTAS was completed in Q3 2025, with topline results expected in Q2 2026, while VANTAGE is expected to finish enrollment in 2026. Interim data shared in June 2024 and at AASLD 2024 showed encouraging improvements in pruritus in both PBC and PSC.

In October 2024, Volixibat was granted both Orphan Drug Designation (ODD) and Breakthrough Therapy Designation (BTD) by the US FDA for the treatment of PBC. Mirum Pharmaceuticals are developing the compound under exclusive global licenses from Shire International (acquired by Takeda) and Sanofi-Aventis, encompassing rights for development, manufacturing, commercialization, and sublicensing. Volixibat's US composition-of-matter patent extends through 2027, with pending method-of-use and dosing patents potentially prolonging protection until 2042.

Tharimmune's TH-104 (formerly AV104) is a proprietary transmucosal buccal film incorporating nalmefene, designed to modulate µ-opioid and kappa-opioid receptors involved in itch signaling pathways. Phase I data support advancement to Phase II in the US, following positive feedback from the FDA and completion of CMC activities. The upcoming Phase II trial will target moderate-to-severe pruritus in PBC (referred to as a hepatic impairment study) and is expected to initiate in 2026. Additionally, TH-104 is advancing toward a near-term NDA submission for the prevention of ultrapotent opioid exposure, supported by new patents valid until at least 2040.

At AASLD's The Liver Meeting, Tharimmune presented Phase I data demonstrating a correlation between plasma exposure and symptom improvement, along with favorable tolerability and no unexpected safety concerns. Under the Avior Patent License Agreement, Tharimmune holds exclusive global rights to develop and commercialize TH-104, with financial terms including a USD 0.4 million upfront payment, USD 0.15 million in quarterly fees, up to USD 24.25 million in development milestones, additional sales-based payments, and low to mid-single-digit royalties.

The anticipated launch of these emerging therapies are poised to transform the cholestatic pruritus market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the cholestatic pruritus market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

Discover more about therapy for cholestatic pruritus @ Cholestatic Pruritus Clinical Trials 

What is Cholestatic Pruritus?

Cholestatic pruritus, a common and distressing symptom associated with liver disorders involving impaired bile formation or obstruction of bile flow, results from various underlying causes, including bile duct injury, decreased hepatic bile secretion, or intrahepatic or extrahepatic blockage. Despite its clinical importance, it is often underdiagnosed. The itch typically affects the palms and soles, intensifies at night, and leads to sleep disruption, fatigue, and diminished quality of life, with current therapies offering limited relief. Although its exact mechanisms remain unclear, research indicates a multifactorial origin in which liver-derived pruritogens, including bile acids, serotonin, progesterone metabolites, endogenous opioids, and lysophosphatidic acids, stimulate primary itch neurons in the skin, relaying signals to the central nervous system.

Cholestatic Pruritus Epidemiology Segmentation

The cholestatic pruritus epidemiology section provides insights into the historical and current cholestatic pruritus patient pool and forecasted trends for the leading markets. The US had an estimated 108,000 PBC cases in 2024, making it the most prevalent rare cholestatic liver disease, followed by roughly 30,000 PSC cases.

The cholestatic pruritus market report proffers epidemiological analysis for the study period 2020–2034 in the US, segmented into:

• Total Diagnosed Prevalent Cases of Liver Diseases
• Total Diagnosed Prevalent Cases of Cholestatic Pruritus in Liver Diseases

Scope of the Cholestatic Pruritus Market Report

• Therapeutic Assessment: Cholestatic Pruritus current marketed and emerging therapies
• Cholestatic Pruritus Market Dynamics: Key Market Forecast Assumptions of Emerging Cholestatic Pruritus Drugs and Market Outlook
• Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
• Unmet Needs, KOL's views, Analyst's views, Cholestatic Pruritus Market Access and Reimbursement

Download the report to understand which factors are driving cholestatic pruritus therapeutics market trends @ Cholestatic Pruritus Market Trends

Table of Contents

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