Primary biliary cholangitis is a chronic autoimmune cholestatic liver disease characterized by progressive destruction of small intrahepatic bile ducts and risk of cirrhosis.
GENFIT will receive a $20 million milestone from Ipsen after Iqirvo posted $208 million in 2025 net sales in primary biliary cholangitis. The sales also triggered a €30 million instalment under GENFIT’s royalty-financing deal.
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 |
|---|---|---|---|
| NCT07598669 |
Austrian PBC Registry |
RECRUITING | |
| NCT07573514 |
Patients With Primary Biliary Cholangitis |
ACTIVE_NOT_RECRUITING | NA |
| NCT07449793 |
Biochemical Response and Clinical Outcomes in Patients With PBC |
RECRUITING | |
| NCT07424677 |
Study of Saroglitazar Magnesium for PBC Patients With Incomplete Response or Intolerant to UDCA Therapy |
NOT_YET_RECRUITING | PHASE3 |
| NCT07319169 |
The Value of Spleen Stiffness Measurement in Patients With PBC |
NOT_YET_RECRUITING | NA |
| NCT07282353 |
A Study of CS0159 in Patients With PBC With Inadequate Response or Intolerance to UDCA |
RECRUITING | PHASE3 |
| NCT07216235 |
Long-Term Study to Evaluate the Safety and Efficacy in Participants With Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes |
NOT_YET_RECRUITING | PHASE3 |
| NCT07122206 |
Monitoring the Response of Combination Ursodiol and Seladelpar Treatment |
NOT_YET_RECRUITING | |
| NCT07049887 |
A Study Describing Scratch and Sleep Patterns in Patients With Primary Biliary Cholangitis (Luminaria) |
COMPLETED | |
| NCT06888115 |
A Study of the Pharmacokinetics and Safety of CS0159 in Subjects With Hepatic Injury |
COMPLETED | PHASE1 |
