Evicenter
P&T meetings

Saroglitazar

Primary biliary cholangitis

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

Company-reported prevalence

Saroglitazar

Overview

FieldValue
DrugSaroglitazar (saroglitazar magnesium)
IndicationPrimary biliary cholangitis
DiseasePrimary biliary cholangitis (PBC)
CompanyZydus Lifesciences Limited, through its wholly owned subsidiary Zydus Therapeutics Inc. (United States); no licensing partner holding rights is named in the documents searched
Documents searchedZydus Therapeutics website home, about us, helping patients, PBC, pipeline, clinical trials, and expanded access pages (undated, read October 2026); press releases of May 9, 2024, 2025 (EPICS-III topline results), 2026 (NDA submission), May 28, 2026, and October 12, 2026; Integrated Annual Report 2025-26 (July 2026); investor presentation, August 2026; quarterly results presentations, February, May, and August 2026; earnings call transcripts of August 12, 2025, November 6, 2025, February 10, 2026, May 19, 2026, and August 11, 2026
Data as ofOctober 14, 2026
Prepared byAI research agent (Claude); not yet reviewed by a person

Company statements of prevalence

United States

No evidence found.

Europe

No evidence found.

Global

No evidence found.

Other countries and regions

No evidence found.

Geography not stated

Prevalence (women over the age of 40): Zydus Therapeutics website, October 2026

“PBC disproportionately affects women, with 1 in 1,000 women over the age of 40 being afflicted, 9 times the rate for men.” (opens the source at this quote in a new tab)

Cited source: 2.1 National Organization for Rare Disorders 2020

Zydus Therapeutics (2026) website, primary biliary cholangitis page, quoted passage highlighted (opens the full-size image in a new tab)
Captured from the passage on the page (opens in a new tab)

Prevalence (women over the age of 40): Zydus press release, May 2024

“PBC disproportionately affects women, with 1 in 1,000 women over the age of 40 being afflicted, 9 times the rate for men.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Zydus Lifesciences (2024) press release, May 9, 2024, quoted passage highlighted (opens the full-size image in a new tab)
Captured from page 1 of 4 (opens in a new tab)

Sources the company cites

National organization for rare disorders 2020

Reference as the company lists it

“Primary biliary cholangitis (2020) NORD (National Organization for Rare Disorders). Available at: https://rarediseases.org/rare-diseases/primary-biliary-cholangitis (Accessed: November 29, 2022).” (opens the source at this quote in a new tab)

Zydus Therapeutics (2026) website, primary biliary cholangitis page, quoted passage highlighted (opens the full-size image in a new tab)
Captured from the passage on the page (opens in a new tab)

Passage carrying the figure

“It has been estimated that PBC is one of the most common autoimmune diseases, affecting nearly 1 in 1000 women over the age of 40.” (opens the source at this quote in a new tab)

“Approximately 25% of patients with PBC are women younger than 40 years of age, and about 10% of patients are men.” (opens the source at this quote in a new tab)

National Organization for Rare Disorders (2020) primary biliary cholangitis report, quoted passage highlighted (opens the full-size image in a new tab)
Captured from the passage on the page (opens in a new tab), shown after selecting Affected Populations

References

  1. National Organization for Rare Disorders (2020) primary biliary cholangitis report (opens in a new tab)
  2. Zydus Lifesciences (2024) press release, May 9, 2024 (opens in a new tab)
  3. Zydus Therapeutics (2026) website, primary biliary cholangitis page (opens in a new tab)