Elafibranor (Iqirvo) Phase III trial in adults with Primary Sclerosing Cholangitis (PSC)

Ipsen’s new Phase 3 ELASCOPE trial (N=350, PCD: Apr 2031) evaluating Iqirvo in PSC was highlighted as the first global Phase 3 trial to assess long-term efficacy and safety outcomes as the primary objective in PSC

Reiterated positive data readout from the Phase 2 ELMWOOD trial of Iqirvo in PSC presented at EASL 2025.

Iqirvo’s packaging and tablet will differ in PSC, reflecting the higher 120mg dose compared with 80mg in PBC.

In PSC, Ipsen seems to be positioning Iqirvo as a potential first-approved treatment for this indication.

Based on the current estimated PCD of the trial of Apr 2031 and assuming that Ipsen is granted 6-month priority review, estimated approval of Iqirvo in PSC would be in 2032