Saroglitazar

Name: Saroglitazar in Primary biliary cholangitis: Access and distribution
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

Access and distribution

2 evidence topics · 2 sources

Commercialization strategy: earnings-call publication

“With respect to US on PBC, the company has decided to launch the product on its own.” (opens the source at this quote in a new tab)

Expanded access

“All expanded access requests must be submitted by the patient’s treating physician” (opens the source at this quote in a new tab)
“This policy does not guarantee access” (opens the source at this quote in a new tab)

Commercial patient-assistance program; pharmacy distribution network

No evidence found.