Conclusions
1 evidence topic · 3 sources
Summary
Saroglitazar remains investigational for PBC in the United States. The sponsor reports Priority Review with a PDUFA target action date of November 27, 2026. The proposed population consists of adults with an inadequate response to UDCA, or patients unable to tolerate UDCA. The available phase 3 evidence primarily addresses biochemical response over 52 weeks; longer-term clinical benefit remains to be established.