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Linerixibat: First Approval.

Sheridan M Hoy¹

¹Springer Nature, Private Bag 65901, Mairangi Bay, Auckland 0754, New Zealand. dru@adis.com.

|June 16, 2026

Summary

This summary is machine-generated.

Linerixibat, an ileal bile acid transporter inhibitor, has gained its first approvals in the US and UK for treating cholestatic pruritus in primary biliary cholangitis patients. This marks a significant milestone for patients with this condition.

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Area of Science:

Hepatology and Gastroenterology
Pharmacology and Therapeutics
Drug Development

Background:

Cholestatic pruritus, often associated with primary biliary cholangitis (PBC), presents a significant unmet need.
Ileal bile acid transporter (IBAT) inhibition is a targeted therapeutic strategy for managing cholestatic liver diseases.
Linerixibat (LYNAVOY®) represents a novel oral therapy developed for this indication.

Purpose of the Study:

To summarize the key development milestones of linerixibat.
To highlight the regulatory approvals of linerixibat for cholestatic pruritus in PBC.

Main Methods:

Review of regulatory submissions and approvals.
Summary of clinical development pathway for linerixibat.

Main Results:

Linerixibat received US FDA approval in March 2026 for cholestatic pruritus in adult PBC patients.
UK approval followed in May 2026 for the same indication.
Regulatory reviews are ongoing in Canada, China, and the EU.

Conclusions:

Linerixibat is the first US FDA-approved therapy for cholestatic pruritus associated with PBC.
These approvals represent a significant advancement in the treatment of PBC-related pruritus.
Further regulatory decisions are anticipated in other key markets.