Saroglitazar

Name: Saroglitazar in Primary biliary cholangitis: Pharmacokinetics
Published: 2026-09-14T15:39:06-04:00

Primary biliary cholangitis

Manufacturer: Zydus Therapeutics
Regulatory submission: NDA submitted by May 2026
Launch: Anticipated in April 2027, the start of Zydus fiscal year 2028
Last updated: September 19, 2026

Section

Product information and disease description Product description Product information Pharmacology

Pharmacokinetics

2 evidence topics · 3 sources

Pharmacokinetics: healthy volunteers

“Saroglitazar was not eliminated via the renal route.” (opens the source at this quote in a new tab)
“The pharmacokinetics of saroglitazar support a once daily dosage schedule.” (opens the source at this quote in a new tab)

Food effect: healthy volunteers, 4-mg tablet

“food reduced Cmax (maximum concentration) of saroglitazar by 30%” (opens the source at this quote in a new tab)
“there is no impact of food on the extent of absorption of saroglitazar.” (opens the source at this quote in a new tab)