Lynavoy (linerixibat)
An approved treatment for Primary Biliary Cholangitis.
The same compound appears under different names depending on the context. Here is how to identify Linerixibat wherever you encounter it, plus the key facts at a glance.
- Generic name
- Linerixibat
- Brand name
- Lynavoy
- Development code
- GSK2330672
- Drug class
- Ileal bile acid transporter (IBAT) inhibitor
- Manufacturer
- Intercept Pharmaceuticals, a subsidiary of Alfasigma (discovered and developed by GSK)
- How it's taken
- One 40 mg tablet by mouth twice a day, swallowed whole at least 30 minutes before any food or drink other than water.
A twice-daily tablet approved by the FDA on March 17, 2026 to treat cholestatic pruritus, the persistent internal itch of primary biliary cholangitis (PBC), in adults. It is the first medicine approved in the US specifically for PBC itch, and it treats the itch rather than the underlying liver disease. In its main trial it lowered itch scores more than placebo over 24 weeks, with a difference already seen by week 2.
Where Linerixibat fits
The first FDA-approved medicine for the itch of PBC. It treats itch rather than the liver disease itself, so it is used alongside UDCA and other PBC treatments; in the main trial, 97% of people were also taking UDCA.
How Linerixibat works
In PBC, bile does not drain properly from the liver, and bile acids and other substances build up in the blood. These are thought to help drive cholestatic pruritus, an itch that comes from inside and is not relieved by scratching. Normally the last part of the small intestine (the ileum) pulls most bile acids back into the body using a pump called the ileal bile acid transporter, or IBAT. Linerixibat blocks that pump, so more bile acids leave the body in stool and blood levels of bile acids fall. The label says the exact way it eases itch is not fully known, and very little of the drug is absorbed into the bloodstream.
Mechanism: Oral ileal bile acid transporter (IBAT) inhibitor that blocks bile acid reabsorption in the gut so more bile acids leave the body in stool
Side effects and safety
- Liver test increases. Seen in 14% on linerixibat against 6% on placebo. Liver tests (ALT, AST, bilirubin and ALP) are done before starting and during treatment, and the drug is stopped if increases persist.
- Diarrhea. The most common side effect. Watch for dehydration; treatment may be paused or stopped if diarrhea persists.
- Low fat-soluble vitamins (A, D, E and K). Vitamin levels and INR (a clotting test) are checked before starting and periodically, and supplements are given if levels are low.
- Bleeding and bone fractures. Bleeding was more common than on placebo, and treatment is paused if bleeding occurs. IBAT inhibitors have been linked to fractures, so bone health and vitamin levels are monitored.
- Liver tests (ALT, AST, total and direct bilirubin, ALP) before starting and during treatment
- Vitamins A, D and E and INR before starting and periodically
- Watch for dehydration if diarrhea occurs
- Bone health checks
Lynavoy has no boxed warning and no contraindications. In the main trial the most common side effects, against placebo, were diarrhea (62% against 18%), abdominal pain (26% against 10%), nausea (10% against 9%), raised ALT liver enzyme (9% against 3%), bleeding events such as bruising or nosebleeds (9% against 3%), raised AST liver enzyme (8% against under 1%), headache (8% against 3%) and indigestion (8% against under 1%). Most diarrhea started in the first 20 days and was mild or moderate, and 4% stopped because of it. Liver test increases were more common on linerixibat (14% against 6%), so the label calls for liver tests before and during treatment. It can lower absorption of the fat-soluble vitamins A, D, E and K, which is linked to bleeding and bone fractures, so vitamin levels are checked before and during treatment. Side effects led 14% of people on linerixibat to stop, against 5% on placebo[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Linerixibat
One 40 mg tablet by mouth twice a day, swallowed whole at least 30 minutes before any food or drink other than water. If a dose is missed, take it as soon as possible and at least 30 minutes before the next meal; if it is more than 6 hours late, skip it and do not take a double dose. Bile acid binding resins such as cholestyramine or colesevelam should be taken at least 4 hours before or after linerixibat[1][8]. It should be avoided in people with decompensated cirrhosis or with past or current liver decompensation events such as variceal bleeding, fluid in the belly or hepatic encephalopathy[1]. Prescriptions are filled through PANTHERx Rare Pharmacy, the exclusive specialty pharmacy named by the maker[9].
Availability and cost
Only available as the brand-name product.
Help paying for Lynavoy
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Interconnect Savings Program: patients with commercial insurance may pay as little as $0 a month for Lynavoy. Not valid for patients enrolled in Medicare, DoD, VA, Medicaid or other federal or state healthcare programs.
For: private insurance · source - Insurance and case manager help
Interconnect Care Managers explain benefits, explore other coverage and financial assistance options, and give ongoing support such as check-ins and refill reminders. Prescriptions are filled through PANTHERx Rare Pharmacy (1-866-347-0951).
The official page does not say who qualifies. Ask the program. · source
Good to know: Lynavoy is marketed by Intercept Pharmaceuticals, a subsidiary of Alfasigma, which licensed linerixibat from GSK (deal closed April 27, 2026). Full co-pay terms are at interconnectsupport.com/en/copay-terms, which timed out when fetched. Specific free-drug or bridge terms were not confirmed.
- From a charity · TotalAssist (formerly PAN Foundation)Primary Biliary Cholangitis fundOpen
Pays for: Out-of-pocket costs for approved medications, up to $2,500 per year. Requires Medicare, Medicaid or TRICARE.
- From a charity · The Assistance FundPrimary Biliary Cholangitis (PBC) fundWaitlist
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
The foundation says: “WAITLIST — Accepting Waitlist Patients. TAF is currently accepting requests to join the enrollment waitlist for this program. Waitlists a…”
Clinical trial results
Approval rested on GLISTEN (NCT04950127), which randomized 238 adults with PBC and itch to linerixibat 40 mg twice daily (119 people) or placebo (119 people) for 24 weeks; 97% were also taking UDCA and 47% were taking another itch medicine. People rated their worst itch on a 0 to 10 scale, starting from an average of about 7.3. Over 24 weeks the monthly itch score fell by 2.86 points on linerixibat against 2.15 points on placebo, a difference of 0.72 points, and a difference was already seen at week 2. Itch-related sleep interference also improved more on linerixibat (2.77 against 2.24 points)[1]. Results were published in The Lancet Gastroenterology and Hepatology[6].
Development history
GSK discovered and developed linerixibat under the code GSK2330672[3]. The FDA received GSK's application on March 24, 2025 and approved Lynavoy on March 17, 2026, with a letter issued to GSK[2]. On March 9, 2026, GSK and Alfasigma announced a license giving Alfasigma worldwide rights, and the deal closed on April 27, 2026[3][5]. Lynavoy is now marketed in the US by Intercept Pharmaceuticals, a wholly owned subsidiary of Alfasigma[1][8]. As conditions of approval, the FDA required a pregnancy outcomes study and completion of LLSAT, a long-term safety trial looking at liver injury, bone health and bleeding[2].
Explore Primary Biliary Cholangitis trials
Other Primary Biliary Cholangitis treatments
PBC treatment has 2 goals: slowing the liver disease and easing symptoms such as itch. UDCA is the first treatment for the disease, with elafibranor (Iqirvo) and seladelpar (Livdelzi) available under accelerated approval for people who do not respond well enough. Linerixibat (Lynavoy), approved in March 2026, is the only FDA-approved medicine specifically for PBC itch. Obeticholic acid (Ocaliva) is no longer available in the US after the FDA withdrew its approval effective November 24, 2025.
Common questions about Linerixibat
▸What is Linerixibat (Lynavoy)?
A twice-daily tablet approved by the FDA on March 17, 2026 to treat cholestatic pruritus, the persistent internal itch of primary biliary cholangitis (PBC), in adults. It is the first medicine approved in the US specifically for PBC itch, and it treats the itch rather than the underlying liver disease. In its main trial it lowered itch scores more than placebo over 24 weeks, with a difference already seen by week 2.
▸How does Linerixibat work?
In PBC, bile does not drain properly from the liver, and bile acids and other substances build up in the blood. These are thought to help drive cholestatic pruritus, an itch that comes from inside and is not relieved by scratching. Normally the last part of the small intestine (the ileum) pulls most bile acids back into the body using a pump called the ileal bile acid transporter, or IBAT. Linerixibat blocks that pump, so more bile acids leave the body in stool and blood levels of bile acids fall. The label says the exact way it eases itch is not fully known, and very little of the drug is absorbed into the bloodstream.
▸What are the side effects of Linerixibat?
Lynavoy has no boxed warning and no contraindications. In the main trial the most common side effects, against placebo, were diarrhea (62% against 18%), abdominal pain (26% against 10%), nausea (10% against 9%), raised ALT liver enzyme (9% against 3%), bleeding events such as bruising or nosebleeds (9% against 3%), raised AST liver enzyme (8% against under 1%), headache (8% against 3%) and indigestion (8% against under 1%). Most diarrhea started in the first 20 days and was mild or moderate, and 4% stopped because of it. Liver test increases were more common on linerixibat (14% against 6%), so the label calls for liver tests before and during treatment. It can lower absorption of the fat-soluble vitamins A, D, E and K, which is linked to bleeding and bone fractures, so vitamin levels are checked before and during treatment. Side effects led 14% of people on linerixibat to stop, against 5% on placebo[1].
▸How is Linerixibat taken?
One 40 mg tablet by mouth twice a day, swallowed whole at least 30 minutes before any food or drink other than water. If a dose is missed, take it as soon as possible and at least 30 minutes before the next meal; if it is more than 6 hours late, skip it and do not take a double dose. Bile acid binding resins such as cholestyramine or colesevelam should be taken at least 4 hours before or after linerixibat[1][8]. It should be avoided in people with decompensated cirrhosis or with past or current liver decompensation events such as variceal bleeding, fluid in the belly or hepatic encephalopathy[1]. Prescriptions are filled through PANTHERx Rare Pharmacy, the exclusive specialty pharmacy named by the maker[9].
▸Is Linerixibat FDA approved?
Yes, Linerixibat (Lynavoy) is FDA approved (2026) for the treatment of Primary Biliary Cholangitis.
▸What is Lynavoy used for?
Lynavoy (linerixibat) treats cholestatic pruritus, the persistent internal itch caused by primary biliary cholangitis, in adults. The FDA approved it on March 17, 2026. It eases itch but does not treat the underlying liver disease, so it is taken alongside PBC medicines such as UDCA.
▸Does Lynavoy cause diarrhea?
Diarrhea is the most common side effect. In the GLISTEN trial it affected 62% of people on linerixibat against 18% on placebo, usually starting in the first 20 days, and most cases were mild or moderate. About 4% stopped treatment because of diarrhea. Drink fluids and call your doctor if it does not go away.
▸Who makes Lynavoy?
GSK discovered and developed linerixibat, and the FDA approval letter was issued to GSK on March 17, 2026. GSK then licensed worldwide rights to Alfasigma in a deal that closed on April 27, 2026. Lynavoy is now marketed in the US by Intercept Pharmaceuticals, a subsidiary of Alfasigma, and is filled through PANTHERx Rare Pharmacy.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- Alfasigma · 2026-03-09. GSK and Alfasigma announce agreement on worldwide rights for linerixibat. https://www.alfasigma.com/news-media/gsk-and-alfasigma-announce-agreement-on-worldwide-rights-for-linerixibat/
- Alfasigma · 2026-03-19. Linerixibat approved for use in the U.S. for the treatment of cholestatic pruritus in primary biliary cholangitis (PBC). https://www.alfasigma.com/news-media/linerixibat-approved-for-use-in-the-u-s-for-the-treatment-of-cholestatic-pruritus-in-primary-biliary-cholangitis-pbc/
- Alfasigma · 2026-04-27. Alfasigma Completes Agreement with GSK for linerixibat. https://www.alfasigma.com/news-media/alfasigma-completes-agreement-with-gsk-for-linerixibat/
- The Lancet Gastroenterology and Hepatology · 2026. Linerixibat in patients with primary biliary cholangitis and cholestatic pruritus (GLISTEN): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial. https://doi.org/10.1016/S2468-1253(25)00192-X
- ClinicalTrials.gov. Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN). https://clinicaltrials.gov/study/NCT04950127
- U.S. Food and Drug Administration, Federal Register · 2025-11-24. Withdrawal of Approval of New Drug Application for OCALIVA (Obeticholic Acid) Tablets. https://www.federalregister.gov/documents/2025/11/24/2025-20767/intercept-pharmaceuticals-inc-et-al-withdrawal-of-approval-of-new-drug-application-for-ocaliva