Linerixibat is an ileal bile acid transporter inhibitor marketed as Lynavoy for cholestatic pruritus in primary biliary cholangitis. It reduces pruritus-related mediators by inhibiting bile acid reuptake. The FDA first approved it on March 17, 2026.
The FDA announced major policy changes including requiring only one study for drug approvals instead of two, and offering performance bonuses to reviewers who complete work ahead of schedule while maintaining thoroughness.
GSK agreed to license linerixibat to Alfasigma in a deal worth up to $690 million, while Eisai received orphan drug designation in Japan for E2086, a novel selective orexin 2 receptor agonist for narcolepsy.
The FDA is set to announce decisions in March 2026 on several drug applications, including label expansions for approved therapies and new drug candidates, with some making repeat approval attempts.
The FDA is set to make approval decisions on five drug applications in March 2026, including treatments for psoriatic arthritis, dry eye disease, hypothalamic obesity, cholestatic pruritus, and a rare genetic disorder.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT05448170 |
Linerixibat Compassionate Use for Cholestatic Pruritus Adult Patients With Primary Biliary Cholangitis (PBC) |
AVAILABLE | |
| NCT05435170 |
Food Effect Study of Linerixibat Tablets in Healthy Adult Participants |
COMPLETED | PHASE1 |
| NCT05393076 |
Phase I Study of Linerixibat in Adults With Moderate Hepatic Impairment and Healthy Controls |
COMPLETED | PHASE1 |
| NCT05133830 |
Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Adult Participants |
COMPLETED | PHASE1 |
| NCT04950127 |
Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN) |
COMPLETED | PHASE3 |
| NCT04167358 |
Linerixibat Long-term Safety, and Tolerability Study |
ACTIVE_NOT_RECRUITING | PHASE3 |
