Gilead Sciences’ Seladelpar Study: A Promising Step in PBC Treatment

Gilead Sciences ((GILD)) announced an update on their ongoing clinical study.

Gilead Sciences is currently conducting a Phase 3 clinical study titled ‘AFFIRM: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.’ The study aims to assess the efficacy of Seladelpar in improving clinical outcomes for patients suffering from PBC and compensated cirrhosis, a chronic liver disease. This research is significant as it could lead to new treatment options for this condition.

The intervention being tested is Seladelpar, an experimental drug administered in capsule form. Participants with CP-A cirrhosis receive a 10 mg dose daily, while those with CP-B cirrhosis receive a 5 mg dose daily, both for up to 36 months. A placebo group is also included for comparison.

The study employs a randomized, double-blind, placebo-controlled design, meaning participants are randomly assigned to either the Seladelpar or placebo group, and neither the participants nor the investigators know which treatment each participant receives. The primary purpose of the study is treatment-focused.

The study began on September 18, 2023, and is currently recruiting participants. The primary completion and estimated completion dates have not been specified, but the last update was submitted on August 21, 2025, indicating ongoing progress.

This clinical update could positively impact Gilead Sciences’ stock performance by boosting investor confidence, especially if the results demonstrate significant benefits of Seladelpar. It also places Gilead in a competitive position within the pharmaceutical industry, particularly in the liver disease treatment market.

The study is ongoing, and further details are available on the ClinicalTrials portal.