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The FDA is expected to decide on Saroglitazar for Primary biliary cholangitis by November 27, 2026, under an NDA from Zydus Therapeutics.
What the FDA is deciding on Saroglitazar for Primary biliary cholangitis
The FDA is reviewing Zydus Therapeutics' application to approve Saroglitazar for primary biliary cholangitis. Dual PPAR agonist under priority review for second-line PBC.
Who the Saroglitazar decision matters to
Primary Biliary Cholangitis (PBC) is a chronic autoimmune liver disease in which the immune system mistakenly attacks the small bile ducts in the liver, leading to bile duct destruction and progressive liver damage. The condition predominantly affects middle-aged women and progresses slowly, ultimately leading to cirrhosis and liver failure if untreated.
PBC is characterized by elevated cholestasis markers and presence of antimitochondrial antibodies.
Prevalence: About 14.6 per 100,000 people worldwide in a 2021 pooled analysis of 47 population studies, highest in North America (21.8 per 100,000) and lowest in the Asia-Pacific region (9.8 per 100,000). Rates are rising in all regions (Lv et al., J Gastroenterol Hepatol 2021). See our full Primary Biliary Cholangitis page for current treatments, recruiting trials, and community resources.
What an approval or a rejection of Saroglitazar would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. The letter describes what the FDA wants addressed, and the company then decides whether to resubmit, run more studies or stop. Either way, this page updates with the outcome and what it means.
Where Primary Biliary Cholangitis treatment stands today
Read our full Primary Biliary Cholangitis treatment summary
Research in Primary Biliary Cholangitis is advancing treatment options for patients who don't respond well to traditional ursodeoxycholic acid therapy. Saroglitazar, a PPAR alpha and gamma agonist from Zydus, faces an FDA decision on November 27, 2026.
In its EPICS-III trial, 56.7% of people on saroglitazar reached the liver blood test goal at 52 weeks against 9.8% on placebo, according to Zydus. Other open trials test CS0159 in a Phase 3 trial (NCT07282353), seladelpar combined with Gilead's FXR agonist cilofexor (NCT07841977), and the fibrates bezafibrate and fenofibrate.
Trials carefully measure how well treatment works using liver enzyme levels, imaging studies of liver stiffness, and importantly, patient survival without needing transplantation. Understanding whether you respond to standard UDCA therapy helps determine which newer agents might benefit you most.
Combination approaches pairing UDCA with emerging therapies are increasingly studied.
Biomarkers that predict which patients will respond to specific treatments are helping guide personalized medicine approaches. Your baseline disease stage affects trial eligibility and expected outcomes.
Two once-daily pills now have FDA accelerated approval for adults whose PBC has not responded well enough to UDCA, or who cannot take it: Iqirvo (elafibranor), approved in June 2024, and Livdelzi (seladelpar), approved in August 2024, and both still have confirmatory outcome trials underway.
Ocaliva (obeticholic acid) is no longer available in the US, because the FDA withdrew its approval effective November 24, 2025, at Intercept's request, after the FDA found that its confirmatory trial did not verify clinical benefit. For PBC itch, the FDA approved Lynavoy (linerixibat) in March 2026, the first medicine approved in the US specifically for itch caused by PBC.
The Primary Biliary Cholangitis page has every treatment and trial →Meanwhile, 38 Primary Biliary Cholangitis studies are open or about to open
Whatever the FDA decides here, research on Primary Biliary Cholangitis does not stop. Of these, 20 test a treatment; the others follow patients over time. The most recently updated:
We'll email you when the decision is public, with what it means in plain language, and when new trials open for Primary Biliary Cholangitis. Unsubscribe anytime.
- Trial Alerts, when a new trial opens or a trial changes
- Disease Updates, FDA decisions and condition news, usually 1 or 2 emails a month
Frequently asked questions
When will the FDA decide on Saroglitazar?
The FDA's target date (PDUFA date) for Saroglitazar in Primary biliary cholangitis is November 27, 2026.
Who disclosed it: Zydus Therapeutics. The FDA does not publish these dates.
Can it move: the FDA can act early, and a major amendment to the application can push the date back 3 months.
Source: Zydus announcement
What is Saroglitazar being reviewed for?
Zydus Therapeutics submitted an NDA for Saroglitazar in Primary biliary cholangitis.
What to know: Dual PPAR agonist under priority review for second-line PBC.
Is there already an FDA-approved treatment for Primary Biliary Cholangitis?
Yes. Trial Friend's drug list includes 3 FDA-approved drugs for Primary Biliary Cholangitis.
Approved: Livdelzi (seladelpar), Iqirvo (elafibranor), Lynavoy (linerixibat).
Check: the Primary Biliary Cholangitis page also searches FDA drug labels for approved treatments.
Can I get Saroglitazar before the FDA decides?
Usually only through a clinical trial or an expanded access program, and the company decides whether to offer one.
Trials: 38 Primary Biliary Cholangitis studies are open or about to open, 20 of them testing a treatment. See them.
Check your fit: Match Me compares your details with every open trial.
Expanded access: your doctor can ask Zydus Therapeutics directly. Registered programs are listed on ClinicalTrials.gov.
How much will Saroglitazar cost?
Zydus Therapeutics has not announced a price. Drugmakers usually set it around approval.
Help paying: drugmaker programs and charity funds usually open at launch.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Saroglitazar decision?
This page updates with the outcome the day it is announced.
If approved: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
If not approved: a complete response letter means the FDA declined the application in its current form. Many are about manufacturing or how data were presented, and companies often resubmit.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from Zydus announcement. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.