FDA
FDA approves Lynavoy for cholestatic pruritus in patients with primary biliary cholangitis
Brand name: Lynavoy
Generic name: linerixibat
Manufacturer: GlaxoSmithKline
Approval date: March 17, 2026
FDA has approved Lynavoy (linerixibat) for the treatment of cholestatic pruritus in adult patients with primary biliary cholangitis (PBC). PBC is a rare autoimmune disease in which normal bile flow from the liver is disrupted. Accumulation of bile acids in the bloodstream is believed to contribute to cholestatic pruritus—an internal itching sensation that can’t be relieved by scratching. Lynavoy, an ileal bile acid transporter (IBAT) inhibitor, works by blocking reuptake of bile acids, thus reducing several mediators of pruritus in circulation. Lynavoy has been granted Orphan Drug Designation in the U.S.
Efficacy
Approval is based on data from the double-blind, randomized, placebo-controlled Phase 3 GLISTEN trial, which enrolled 238 patients with PBC and moderate-to-severe pruritus at 115 sites in 19 countries. Patients were randomized to receive Lynavoy (linerixibat) 40 mg orally twice a day or placebo. The primary endpoint was change in pruritus over 24 weeks evaluated using the WI-NRS (Worst Itch Numerical Rating Scale), ranging from 0 (no itching) to 10 (worst imaginable itching).
The study met its primary and key secondary endpoints, showing significant, early (by week two), and sustained (through 24 weeks) improvements in cholestatic pruritus and itch-related sleep disturbance vs. placebo. For the primary endpoint of change from baseline in WI‑NRS score over 24 weeks, linerixibat significantly improved pruritus compared with placebo (-2.86 for linerixibat,-2.15 for placebo, adjusted mean difference: -0.72, [95% confidence interval:-1.15, -0.28], p=0.001).
Safety
Common adverse reactions (≥5%): diarrhea, abdominal pain, nausea, increased ALT, hemorrhage, increased AST, headache, dyspepsia, gastroesophageal reflux disease, abdominal distension, dizziness, and
arthralgia.
Of note, diarrhea and abdominal pain were reported in 62% and 26% of linerixibat-treated patients, respectively. Most diarrhea events occurred within the first 20 days of starting linerixibat. Treatment was discontinued due to diarrhea in 4% of patients on linerixibat vs. <1% on placebo, and due to abdominal pain in 4% on linerixibat vs. none on placebo.
Recommended dose
The recommended dosage of Lynavoy is 40 mg orally twice daily. Patients should swallow tablets whole at least 30 minutes before any food or beverage (other than water).
Sources:
(2026, March 19). Lynavoy (linerixibat) approved by the US FDA for cholestatic pruritus in patients with primary biliary cholangitis (PBC). [Press release]. https://www.gsk.com/en-gb/media/press-releases/lynavoy-linerixibat-approved-by-the-us-fda/
Lynavoy (linerixibat). [Package insert]. https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Lynavoy/pdf/LYNAVOY-PI-PIL.PDF Dated March 2026.