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FDA approval · GSK · Gastroenterology

Lynavoylinerixibat

FDA approves the first medicine for cholestatic itch in primary biliary cholangitis.

CompareGSK press release
FDA approval · New moleculeFirst approved for cholestatic itch in PBC40-second read

Lynavoylinerixibat

GSK · Ileal bile acid transporter (IBAT) inhibitor · Gastroenterology

Bottom line for your patients

Patients with PBC-related itch have an approved treatment for the symptom for the first time. The average itch improvement over placebo was under one point on a 0-10 scale, and diarrhea was common.

Drug brief
Drug IQ
Who it is for
Adult patients with primary biliary cholangitis who have cholestatic pruritus.
What changes
GSK states it is the first medicine approved in the US for this indication. GLISTEN compared linerixibat with placebo.
The evidence
Change from baseline in monthly itch score over 24 weeks favored linerixibat (n=119) versus placebo (n=119) on the 0-10 worst itch numerical rating scale (LS mean difference -0.72 [95% CI -1.15, -0.28], p=0.001). Itch-related sleep interference also improved (p=0.024).Placebo-controlled randomized trialGLISTEN · Phase 3Randomized against placebo: shows that it works, not how it compares with existing treatments.
Watch for
The most frequently reported adverse events were diarrhea (61%) and abdominal pain (18%), mostly mild to moderate. Treatment discontinuation due to diarrhea was 4% versus <1% with placebo, and due to abdominal pain 4% versus none.
How it is given
OralDose and schedule are not stated in the release; see the prescribing information.
What the approval tells you
New molecule. An active ingredient the FDA had not approved before.Orphan drug. Developed for a condition affecting fewer than 200,000 people in the US. Trials are often smaller.

Clinical summary

Lynavoy is an oral ileal bile acid transporter (IBAT) inhibitor for cholestatic pruritus in adults with primary biliary cholangitis (PBC). In the GLISTEN phase III trial, it improved monthly worst-itch score versus placebo over 24 weeks (least squares mean difference -0.72 on a 0-10 scale, p=0.001). Diarrhea was reported in 61% of patients and abdominal pain in 18%.

From the source 9

GSK press release

The GSK press release's own words, quoted exactly. Each line is what a claim on this page was checked against.

  1. GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Lynavoy (linerixibat) for the treatment of cholestatic pruritus in adult patients with PBC. Lynavoy, an ileal bile acid transporter (IBAT) inhibitor that reduces multiple drivers of chronic itch, is the first medicine approved in the US for this indication.5

    Backs · Approved indication; IBAT inhibitor; first medicine approved in the US for this indication

  2. GLISTEN is a double-blind, randomised, placebo-controlled, phase III trial.

    Backs · Double-blind, randomized, placebo-controlled, phase III

  3. The primary endpoint of change from baseline in monthly itch score showed linerixibat (n=119) significantly improved itch versus placebo (n=119) over 24-weeks, as measured on a 0-10 numerical rating scale (NRS) for the worst itch (WI-NRS) (least squares [LS] mean difference [95% CI]: -0.72 [-1.15, -0.28], p=0.001).

    Backs · n=119 per arm (total not stated, so n is null); 24 weeks; 0-10 scale; LS mean difference -0.72; p=0.001

View all 9 lines

  1. The primary and key secondary endpoints of the study were met, demonstrating significant, rapid (at week two), and sustained (over 24 weeks) improvements in cholestatic pruritus (p<=0.001) and itch-related sleep interference (p=0.024) versus placebo.

    Backs · Sleep interference p=0.024

  2. The most frequently reported adverse events were diarrhoea (61%) and abdominal pain (18%), both of which were mostly mild to moderate.

    Backs · Diarrhea 61%, abdominal pain 18%

  3. Treatment discontinuation due to diarrhoea was in 4% of patients versus <1% in placebo, and abdominal pain in 4% versus none in placebo.8

    Backs · Discontinuation 4% vs <1%, 4% vs none

  4. Linerixibat has been granted Orphan Drug Designation in the US, EU and Japan, and priority review in China, for the treatment of cholestatic pruritus in patients with PBC.

    Backs · Orphan drug designation

  5. Linerixibat is an IBAT inhibitor, a targeted oral agent to treat cholestatic pruritus (itch) associated with the rare autoimmune liver disease PBC.8

    Backs · Oral agent

  6. Lynavoy | linerixibat | 3/17/2026 | To treat cholestatic pruritus associated with primary biliary cholangitis

    Backs · FDA action date 2026-03-17 (from FDA Novel Drug Approvals for 2026 table, https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026; the GSK release is dated 19 March 2026 and does not state the action date)

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