medcelerator · clinician one-pager
New Pill for Itch from a Bile-Duct Disease
Lynavoy (linerixibat) for cholestatic itch in adults with primary biliary cholangitis — oral IBAT inhibitor
FDA Approved · United States, Canada, United Kingdom · September 4, 2026
Condition: Primary Biliary Cholangitis
Who this is for
Lynavoy (linerixibat) is a pill taken twice daily for itch caused by primary biliary cholangitis, a liver disease, in adults. The United States and the United Kingdom approved it in 2026.
Next clinical step
The US Food and Drug Administration (FDA) has approved this medicine. In the United States and the United Kingdom, ask your doctor or a specialist whether it suits you. They can write a prescription. Insurance or public drug plan coverage is not guaranteed. In Canada, authorisation is not confirmed; see Possible routes below if any are listed.
Ways to access this treatment
United States · Prescription
US prescription (FDA-labelled)
https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c00317c8-709c-4707-a6d1-632bff123026
United Kingdom · Prescription
UK prescription (MHRA-authorised)
https://www.gov.uk/government/news/mhra-approves-linerixibat-lynavoy-for-the-treatment-of-itch-due-to-biliary-tract-disease
Possible routes (not confirmed)
Canada · Health Canada Special Access Programme (SAP) · Applicability unknown
Health Canada Special Access Programme (manufacturer must agree)
SAP here depends on the manufacturer agreeing to supply; no confirmation for this drug.
https://www.canada.ca/en/health-canada/services/drugs-health-products/special-access/drugs.html
Canada · Company expanded-access programme · Applicability unknown
GSK compassionate-use programme NCT05448170 (individual patients)
Compassionate-use record lists no sites or countries and was last verified 2025-02; Canada is not named.
https://clinicaltrials.gov/study/NCT05448170
General resources for further research
Canadian Clinical Trial Search Portal (Health Canada)
Health Canada's public search of the drug and biologic clinical trials it has authorised in Canada (phase 1 to 3, since April 2013). Search by condition, drug, or trial status and see where trials are running. It replaced the Health Canada Clinical Trials Database in July 2026. A listing is not enrolment, and Health Canada does not recruit patients: ask your clinician and contact the trial sponsor.
https://clinical-trials-search.canada.ca/en/home
ClinicalTrials.gov
US National Library of Medicine registry of clinical studies. Search by condition, drug, NCT number, and location. A listing is not enrolment, eligibility, or funding. Talk with the trial contact and a clinician before assuming a slot exists.
https://clinicaltrials.gov/
AI-produced discussion aid; not prescribing instructions. Approval does not establish coverage. Full article: https://medcelerator.com/articles/lynavoy-linerixibat