We are a clinical-stage biopharmaceutical company focused on improving the lives of people with liver and other chronic diseases that have high unmet medical need through a pipeline of innovative therapies. With a long history of drug discovery and development, we deliver value to all stakeholders through a deep understanding of the underlying mechanisms of inflammation and fibrosis, unique targets that play a role in their progression, and innovative therapies for liver and chronic diseases.
Seladelpar is a first-in-class oral , selective, PPARδ agonist that has been shown to regulate critical metabolic and liver disease pathways in indications with high unmet medical need. It has received Breakthrough Therapy Designation (FDA) and PRIME status (EMEA), Orphan Drug Designation in the U.S. and Europe, for treatment of patients with primary biliary cholangitis (PBC). Backed by an extensive body of clinical evidence and global patient experience through Phase 2 and Phase 3 ENHANCE studies of seladelpar in Primary Biliary Cholangitis (PBC), CymaBay initiated an international pivotal Phase 3 study (RESPONSE) in early 2021.
Our pipeline also includes an additional investigational product for other chronic diseases.