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Saroglitazar

Primary biliary cholangitis

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

Product information and disease descriptionProduct descriptionProduct information

Special populations

3 evidence topics · 2 sources

Hepatic impairment: single-dose study
Population or parameterQuoted finding
Mild and moderate hepatic impairment“did not significantly affect the PK of saroglitazar”
Severe hepatic impairment: exposure“increased 3-fold”
Severe hepatic impairment: clearance“61% lower”
Severe hepatic impairment: authors’ qualification“may require close monitoring or dose adjustments”
Cholestatic cirrhosis and renal impairment: single-dose pharmacokinetics in non-cirrhotic cholestatic liver disease and severe renal impairment
Pregnancy, lactation, and pediatric use

No evidence found.