Saroglitazar

Name: Saroglitazar in Primary biliary cholangitis: Natural history, survival, and mortality
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 Place of product in therapy Disease description

Natural history, survival, and mortality

2 evidence topics · 1 source

ALP and bilirubin as prognostic markers

“Combining levels of alkaline phosphatase and bilirubin increased the ability to predict patient survival times.” (opens the source at this quote in a new tab)

Ten-year survival by ALP level one year after study enrollment

ALP category	Reported ten-year survival
At or below 2.0 times ULN	“alkaline phosphatase levels ≤ 2.0 times the ULN, 84% survived for 10 years”
Above 2.0 times ULN	“62% of those with levels >2.0 times the ULN”