Scientists at CymaBay are committed to identifying unique targets in pathways that have critical roles in disease. We are developing novel small molecules that regulate metabolism, inflammation, and fibrosis with the potential to address unmet needs in the treatment of inflammatory liver diseases and other chronic diseases.
| Indication or Program | Phase 3 |
|---|---|
Primary Biliary Cholangitis Incomplete responders (ALP>1.67xULN) |
Phase 3 Phase in progress
|
Primary Biliary Cholangitis |
Phase 3 Phase in progress
|
Primary Biliary Cholangitis |
Phase 3 Phase in progress
|
Primary Biliary Cholangitis |
Phase 3 Phase in progress
|
Seladelpar, is a first-in-class oral, selective delpar, or peroxisome proliferator-activated receptor-delta (PPARĪ“) agonist, that has been shown to regulate critical metabolic and liver-disease pathways. It is currently being evaluated in a Phase 3 study of patients with primary biliary cholangitis (PBC), a progressive cholestatic inflammatory liver disease. Seladelpar has received Breakthrough Therapy Designation (FDA) in the United States for the treatment of early stage PBC including pruritis and PRIME status (EMA), as well as Orphan Drug Designation in the United States and Europe for the treatment of patients with PBC. It is backed by clinical evidence and global patient experience through its Phase 2 and Phase 3 studies,1 and we initiated an international pivotal Phase 3 study of seladelpar in patients with PBC in 2021.1 Future research could indicate whether it has the potential to be effective in treating other liver diseases such as primary sclerosing cholangitis (PSC).
1. Li NX, et al. Diabetes. 2018;67:1401-1413.