Our Purpose

Developing Transformative Medicines to Restore Health and Improve Patients’ Lives

Potential to reduce the risk of disease progression.
Lessen symptom burden.
Provide greater hope for significantly better health.

It all adds up to more treasured time with family and friends, and motivation to pursue lifelong dreams and passions, and additional milestones reached.

At CymaBay, we are driven by our relentless commitment to restoring health and improving the lives of people with chronic liver, metabolic, and inflammatory diseases through innovative treatments that enhance quality of life and overall disease progression.

We understand the urgent need for better treatments now. Each day matters to patients and families affected by these conditions.

We focus on identifying and targeting unique mechanisms involved in inflammation and fibrosis, with the goal of raising the standard of care for treatment that impacts patients and the families who support them.

Our lead product candidate, seladelpar, is being developed for primary biliary cholangitis (PBC), an autoimmune disease that destroys the small bile ducts of the liver. The hallmark of PBC is impaired bile flow (cholestasis), which over time leads to liver damage (inflammation and fibrosis). People living with PBC often have debilitating symptoms including fatigue, itching (pruritus), and sleep disturbance. In later stages, cirrhosis, liver failure, and liver transplantation are inevitable.

Seladelpar is a first-in-class oral, selective delpar, or peroxisome proliferator-activated receptor-delta (PPARδ) agonist. PPARδ regulates pathways impacting cholestasis, lipid metabolism, inflammation, and fibrosis. In clinical trials of patients with PBC, seladelpar improved blood tests for cholestasis and liver damage while also improving itch for those who experienced moderate to severe itching.

Data from multiple clinical trials supports seladelpar’s safety and effectiveness in patients with PBC and seladelpar is currently being evaluated in Phase 3 studies. Due to the high unmet need for new PBC treatments, seladelpar has received Orphan Drug Designation from the U.S. Food & Drug Administration (FDA) and the European Medicines Agency (EMA). Seladelpar also has Breakthrough Therapy Designation from the FDA for early stage PBC and PRIority MEdicine (PRIME) status from the EMA for PBC.

Our Mission

Guided by a deep commitment to patients, CymaBay transforms the lives of people suffering from chronic liver, digestive tract, or inflammatory diseases, by developing innovative medicines that restore health and improve patients’ lives.

Our Vision

Our vision is to conquer metabolic, inflammatory, and fibrotic diseases so patients can lead fulfilling lives without suffering.

Our Company-wide Position

We are focused on developing innovative therapies for diseases of the liver and digestive tract, or that result from inflammation, to restore health and improve patients’ quality of life. We achieve our mission through scientific evidence and the highest quality standards.

Our Pipeline Programs

Indication or Program Pre-clinical Phase 1 Phase 2 Phase 3

(PPARδ agonist)

Primary Biliary Cholangitis
Pre-clinical Phase complete
Primary Biliary Cholangitis incomplete responders
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase in progress

Seladelpar

Ideal
Primary Biliary Cholangitis
Pre-clinical Phase complete
Primary Biliary Cholangitis partial responders
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase in progress
Primary Sclerosing Cholangitis
Pre-clinical Phase complete
Primary Sclerosing Cholangitis
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started

(GPR 119 agonist)

Diabetic Hypoglycemia
Pre-clinical Phase complete
Diabetic Hypoglycemia
Phase 1 Phase complete
Phase 2 Phase in progress
Phase 3 Phase not started

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