Zydus has announced the completion of enrollment of the pivotal Phase 2b/3 of saroglitazar in patients with PBC

Zydus has announced the completion of enrollment of the pivotal Phase 2b/3 EPICS-III trial of saroglitazar in patients with PBC . 

The completion of enrollment is slightly delayed as prior company communications guided patient enrollment completion in Q1 2024. Thus, topline data is estimated for Q2 2025 (given the 52-week primary endpoint)

Zydus previously announced plans to launch saroglitazar in the US in early 2026.

This medicine was designated as an orphan medicine for the treatment of primary biliary cholangitis in the European Union on 19 July 2021. This means that the developer will receive scientific and regulatory support from EMA to advance their medicine to the stage where they can apply for a marketing authorisation.

Orphan designation does not mean the medicine is available or authorised for use. All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.

source: article