Evicenter
P&T meetings

Saroglitazar

Primary biliary cholangitis

Manufacturer
Zydus Therapeutics
Regulatory submission
NDA submitted by May 2026
Last updated
81 sources

Product information and disease descriptionPlace of product in therapyApproaches to treatment

Place in treatment, anticipated use, and care setting

1 evidence topic · 5 sources

Summary

The proposed U.S. indication positions saroglitazar as combination treatment with UDCA in adults with an inadequate response, or as monotherapy in patients unable to tolerate UDCA. This is a proposed indication, not an approved prescribing recommendation. PBC management consensus includes referral to a centre with specific clinical and research expertise in PBC. The expanded-access policy requires requests from the treating physician and does not guarantee access.