Neither pill has been tested against the other, so for someone with primary biliary cholangitis (PBC) whose liver tests stay high on ursodiol, the choice between Iqirvo and Livdelzi comes down to the fine print on each FDA label. One showed a clear drop in itch in its trial and the other did not. One warns about muscle injury, especially alongside a statin, and about birth control that contains ethinyl estradiol, a form of estrogen, and the other does not. Both carry a fracture warning, and only one reports a decline in eGFR, a kidney function lab test, as a trial finding.
Iqirvo vs Livdelzi for Primary Biliary Cholangitis, Side by Side
Iqirvo (elafibranor, from Ipsen) and Livdelzi (seladelpar, from Gilead) are once-a-day pills approved in 2024 for adults with PBC who have not responded well enough to ursodiol (UDCA), taken together with it, or on their own by people who cannot tolerate ursodiol. The FDA approved Iqirvo on June 10, 2024 and Livdelzi on August 14, 2024, both under accelerated approval based on a drop in alkaline phosphatase (ALP), a liver enzyme that runs high when bile ducts are damaged, according to Drugs@FDA and the labels. Both labels say that improvement in survival or in preventing liver failure has not been shown.
Their main trials can be lined up more fairly than most, because ELATIVE (Iqirvo), RESPONSE (Livdelzi) and EPICS-III (saroglitazar) all counted a person as a responder with matching rules after about a year: ALP below 1.67 times the upper limit of normal, an ALP drop of at least 15%, and a normal bilirubin. The labs behind each trial set the upper limit of normal slightly differently. Trial Friend set the 2 journal results beside Zydus's reported EPICS-III result, checked October 17, 2026. On that measure, 51% responded on Iqirvo against 4% on placebo, 62% on Livdelzi against 20%, and 56.7% on saroglitazar against 9.8%. The people enrolled were not identical across trials, so the gap over placebo, 42 to 47 points for all 3, says more than the raw percentages.
- 80 mg tablet once a day, with or without food
- FDA approved June 10, 2024 (accelerated approval)
- Normal ALP reached by 15% against 0% on placebo
In people with moderate to severe itch, the itch score fell 1.93 points on Iqirvo against 1.15 on placebo at week 52, a difference the trial could not separate from chance (Kowdley, NEJM 2024).
- 10 mg capsule once a day, with or without food
- FDA approved August 14, 2024 (accelerated approval)
- Normal ALP reached by 25% against 0% on placebo
Itch relief was a key goal of the trial. In people with moderate to severe itch, the score fell 3.2 points on Livdelzi against 1.7 on placebo at month 6, a real difference (Hirschfield, NEJM 2024; label).
- 1 mg tablet once a day in the trial
- Under FDA priority review
- Approved in India since 2013 for other conditions
Zydus reported less itch than placebo at week 24 on a different itch scale, but not at week 52 (Zydus, 2026).
All 3 trials used matching responder rules at about 1 year (ALP under 1.67 times normal, a drop of at least 15%, normal bilirubin): 51% on Iqirvo against 4% on placebo, 62% on Livdelzi against 20%, and 56.7% on saroglitazar against 9.8%. Livdelzi is the only one whose label shows an itch benefit, and Iqirvo is the only one whose label warns about muscle injury and birth control with ethinyl estradiol.
Why Ocaliva Is Gone, and What Accelerated Approval Means for Iqirvo and Livdelzi
Ocaliva (obeticholic acid) was the second-line PBC pill for 8 years before these 2 arrived, and it held the same kind of accelerated approval. The FDA withdrew it effective November 24, 2025. In the Federal Register notice, the FDA said Intercept's follow-up trial did not verify a clinical benefit and that patients with early-stage disease on Ocaliva had more liver transplants and deaths. Intercept asked for the withdrawal while noting that it disagreed.
Iqirvo and Livdelzi now face the same test. Their approvals rest on ALP, a blood test, and both companies are running outcome trials meant to show fewer cases of liver failure, transplant or death: Ipsen's ELFIDENCE, estimated to finish in May 2029, and Gilead's AFFIRM, estimated to finish in August 2030, according to their ClinicalTrials.gov listings. Both enroll only people with cirrhosis. Neither has reported results.
PBC Itch Treatment With Livdelzi, Iqirvo and Lynavoy
For many people with PBC, itch is the symptom that runs the day. RESPONSE made itch a key secondary goal and Livdelzi met it: in people starting with an itch score of 4 or more out of 10, the score fell 3.2 points by month 6 against 1.7 on placebo. ELATIVE also measured itch, and the change on Iqirvo was not different enough from placebo to count at week 24 or week 52, according to its ClinicalTrials.gov results and the published trial.
Lynavoy (linerixibat), approved March 17, 2026, treats the itch itself and does not lower ALP. In GSK's GLISTEN trial it lowered itch scores more than placebo, with diarrhea in 62% of people taking it, according to its label. Trial Friend's Lynavoy page has the details, including how it is dosed before meals.
Iqirvo and Livdelzi Side Effects, From Fractures to Kidney Tests
Stomach upset leads both lists. On Iqirvo, the label reports abdominal pain and nausea in 11% each against 6% on placebo, vomiting in 11% against 2%, and diarrhea in 11% against 9%. On Livdelzi, headache came in at 8% against 3%, abdominal pain at 7% against 2%, and nausea at 6% against 5%. Neither label has a boxed warning, and neither lists a condition that rules the drug out entirely.
Iqirvo's label updated its warning for drug-induced liver injury in August 2026. It describes 1 case at the approved 80 mg dose and 2 at a higher dose, appearing a median of 85 days after starting, and asks doctors to check liver tests at the start and during treatment, and to pause Iqirvo if liver tests worsen or signs of hepatitis appear. Livdelzi's label reports that kidney function, measured as eGFR, fell by at least 25% in 10% of people against 2% on placebo, then stabilized or moved back toward where it started with continued treatment.
What Iqirvo and Livdelzi Cost, and Help Paying
Medicare's 2024 drug spending data put Iqirvo at $379.40 a tablet and Livdelzi at $419.22 a capsule, before the manufacturer rebates CMS does not publish by drug. One a day for a year works out to about $138,500 for Iqirvo and $153,000 for Livdelzi, Trial Friend's arithmetic from CMS's per-unit figures, checked October 17, 2026. Both launched mid-2024, so CMS's per-patient averages for that year ($37,999 and $29,323) cover only part of a year. For comparison, Medicare spent $87,912 per Ocaliva patient in 2024, a full year on the market.
People on Medicare Part D pay no more than $2,100 out of pocket for covered drugs in 2026. Commercially insured patients can apply for IPSEN CARES copay help for Iqirvo or the Gilead Support Path copay program for Livdelzi, both advertising costs as low as $0; neither works with Medicare or Medicaid. IPSEN CARES staff also help look for other financial support, and Gilead runs a patient assistance program for eligible people without insurance. Trial Friend's help paying page lists both programs with what each covers.
Saroglitazar for PBC, the FDA Decision Due November 27th
The FDA's target date for saroglitazar is November 27, 2026, after Zydus Therapeutics announced on May 28, 2026 that its application had been accepted for priority review. Saroglitazar works on 2 related switches in liver cells, PPAR alpha and PPAR gamma; Iqirvo acts mainly on PPAR alpha and delta, and Livdelzi acts only on PPAR delta. It has been sold in India since 2013, first for high blood fats in people with diabetes and later for fatty liver disease, according to Zydus.
In EPICS-III, 148 adults with PBC were randomized 2 to 1 to saroglitazar 1 mg or placebo for 52 weeks. Zydus reported that 56.7% reached the trial's response goal against 9.8% on placebo, and that serious side effects happened in 6.3% of people on saroglitazar against 11.1% on placebo. Side effects Zydus listed as more common than placebo include headache, high blood pressure and abdominal pain. These results come from the company and have not yet been set out in an FDA label. Trial Friend's saroglitazar decision page will carry the outcome.
“Improvement in survival or prevention of liver decompensation events have not been demonstrated.”
FDA labels for both Iqirvo and Livdelzi, on what accelerated approval has and has not shown
PBC Clinical Trials Open in 2026
Trial Friend counted 21 interventional studies recruiting or about to recruit people with PBC on ClinicalTrials.gov on October 17, 2026, and 5 of them list US sites, 102 site listings in all. The largest US footprints belong to the 2 outcome trials, AFFIRM for Livdelzi (54 US sites) and ELFIDENCE for Iqirvo (43), both for people with cirrhosis. Zydus has 2 saroglitazar studies with a US site, and the Mayo Clinic plans to test nemolizumab, an antibody already used for skin itch, against liver-related itch. Several trials in China and France are testing fenofibrate and bezafibrate, older cholesterol drugs that act on PPAR receptors. The PBC trials page lists every open study with its locations.
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Questions People Ask About Iqirvo, Livdelzi and PBC
Is Livdelzi better than Iqirvo?
No trial has compared them, so neither has been shown to be better. With matching response rules, 62% responded on Livdelzi against 20% on placebo and 51% on Iqirvo against 4%, so the gap over placebo was similar. Livdelzi's label shows an itch benefit and Iqirvo's does not, while Iqirvo's label carries muscle and birth control warnings that Livdelzi's lacks.
Can I take Iqirvo with a statin?
Yes, but with monitoring. The Iqirvo label does not forbid statins; it warns about muscle injury, notes the one rhabdomyolysis case was in a patient with cirrhosis taking a statin, and tells doctors to monitor muscle symptoms and consider periodic CPK blood tests.
Do I stop ursodiol when I start Iqirvo or Livdelzi?
Usually not. Both drugs are approved in combination with ursodiol for people who did not respond well enough to it, and on their own only for people who cannot tolerate ursodiol. In the main trials, 94% to 95% of participants stayed on ursodiol.
Why was Ocaliva taken off the market?
The FDA withdrew Ocaliva's approval effective November 24, 2025, after saying its confirmatory trial did not verify a clinical benefit and that patients with early-stage PBC on the drug had more liver transplants and deaths. Intercept requested the withdrawal while stating that it disagreed with the FDA.
When will the FDA decide on saroglitazar for PBC?
The FDA's target date is November 27, 2026, under priority review. If approved, Zydus has said it plans to launch in the US by March 2027.
Does Iqirvo cause weight gain?
Weight gain was the most common side effect in Iqirvo's trial, in 23% of people, but it happened almost as often on placebo (21%). Weight loss was reported in 5% on Iqirvo against none on placebo.
The outcome trials will settle a question no ALP result can: whether either pill keeps people off the transplant list. Until AFFIRM and ELFIDENCE report, at the earliest in 2029, the label details above, and how a person's own liver tests move in the first 6 to 12 months, are the best guide anyone has.