Zydus Lifesciences' saroglitazar demonstrated significant efficacy in resolving steatohepatitis in a Phase 2b MASH trial, supporting plans for larger, long-term clinical studies.
On Nov 6, 2026 Zydus announced Phase 2b data for saroglitazar in MASH: the primary endpoint was met with statistical significance, with 39.1% resolution of steatohepatitis without fibrosis worsening on the 4 mg dose vs 13.7% on placebo (P=0.002), and a well-tolerated safety profile. Positive trial readouts typically lift the listed parent's shares, though this is a Phase 2b result and the key secondary fibrosis endpoint missed significance, which limits the magnitude.
Its investigational drug saroglitazar met the main goal of a Phase 2b trial in MASH, with 39.1% of patients on the 4 mg dose achieving resolution of steatohepatitis without worsening fibrosis versus 13.7% on placebo, a statistically significant result that supports moving to larger studies.
No. Saroglitazar is investigational for MASH and its safety and effectiveness for that use have not been established; it does hold Orphan Drug, Fast Track and Priority Review designations from the FDA for the treatment of PBC.
Zydus Lifesciences announced that its investigational drug, saroglitazar, met the primary endpoint in a Phase 2b trial for MASH. The study showed 39.1% of patients on the 4 mg dose achieved resolution of steatohepatitis without worsening fibrosis, compared to 13.7% for the placebo group. While the drug showed a favorable safety profile, secondary endpoints regarding fibrosis improvement did not reach statistical significance.
Its investigational drug saroglitazar met the main goal of a Phase 2b trial in MASH, with 39.1% of patients on the 4 mg dose achieving resolution of steatohepatitis without worsening fibrosis versus 13.7% on placebo, a statistically significant result that supports moving to larger studies.
No. Saroglitazar is investigational for MASH and its safety and effectiveness for that use have not been established; it does hold Orphan Drug, Fast Track and Priority Review designations from the FDA for the treatment of PBC.