PBC stands for primary biliary cholangitis, a chronic autoimmune cholestatic liver disease causing progressive destruction of small intrahepatic bile ducts and potentially cirrhosis over time.
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 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 |
|---|---|---|---|
| NCT06715319 |
Obeticholic Acid Versus Placebo, in Combination with Ursodeoxycholic Acid in Patients with Primary Biliary Cirrhosis |
COMPLETED | PHASE3 |
| NCT05050136 |
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis |
RECRUITING | PHASE2 |
| NCT04076527 |
Prospective, Multicenter Cohort Study on Primary Biliary Cholangitis |
UNKNOWN | |
| NCT03146910 |
Swiss Primary Biliary Cholangitis Cohort Study |
RECRUITING | |
| NCT01904058 |
Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis |
COMPLETED | PHASE2 |
| NCT01654731 |
Phase 3 Study of Bezafibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis |
COMPLETED | PHASE3 |
