Livdelzi (seladelpar)

One of 2 second-line PBC pills with FDA accelerated approval, alongside elafibranor (Iqirvo, June 2024). Obeticholic acid (Ocaliva), the older second-line option, is no longer available in the US after the FDA withdrew its approval effective November 24, 2025.

In PBC, the immune system damages the small bile ducts inside the liver, so bile acids back up and injure liver cells. Seladelpar switches on PPAR-delta, a receptor that acts like a control switch in the liver and most other tissues. The label says exactly how it helps in PBC is not well understood, but switching on PPAR-delta appears to lower bile acid production by turning down CYP7A1, the main enzyme the liver uses to make bile acids from cholesterol. In the main trial this showed up as a drop in alkaline phosphatase (ALP), a liver blood test that rises when bile flow is blocked. It has not yet been shown to help people live longer or avoid liver failure.

Livdelzi has no boxed warning and no contraindications. In the main trial the most common side effects, against placebo, were headache (8% against 3%), abdominal pain (7% against 2%), nausea (6% against 5%), a swollen or bloated belly (6% against 3%) and dizziness (5% against 2%). Bone fractures happened in 4% of people on seladelpar and in no one on placebo. The label also warns about rises in liver enzymes, which were seen at doses 5 and 20 times higher than the approved dose, and says to avoid it in people with a complete blockage of the bile ducts. In the trial, 10% of people on seladelpar had a drop of at least 25% in eGFR, a blood test estimate of kidney function, against 2% on placebo, and these drops leveled off or improved with continued treatment^[1].

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Approval rested on RESPONSE (NCT04620733), which randomized 193 adults with PBC who had not responded well enough to UDCA, or could not take it, to seladelpar 10 mg (128 people) or placebo (65 people) for 12 months, with 94% also taking UDCA. The main goal was a combined liver blood test response: ALP below 1.67 times the upper limit of normal, a drop in ALP of at least 15% and a normal bilirubin level. That goal was reached by 62% on seladelpar against 20% on placebo, and ALP came all the way down to the normal range in 25% against 0%. Among people who started with moderate to severe itch (at least 4 on a 0 to 10 scale), the itch score fell by 3.2 points on seladelpar against 1.7 points on placebo at 6 months^[1][5].

Seladelpar was studied in PBC under the code MBX-8025^[8], and the FDA approval letter was issued to its developer, CymaBay Therapeutics, which Gilead acquired^[2][4]. The FDA granted accelerated approval as Livdelzi on August 14, 2024, based on the drop in ALP^[2]. Accelerated approval requires a confirmatory trial: AFFIRM (NCT06051617), a placebo-controlled trial in people with PBC and compensated cirrhosis that measures death, liver transplant and signs of liver failure, with completion planned for August 2029 under the timetable in the approval letter^[2][7]. On January 30, 2026, the FDA approved label updates to the drug interaction and liver impairment sections^[3]. Livdelzi also received Breakthrough Therapy and Orphan Drug designations^[4].

UDCA remains the first treatment for PBC. For people who do not respond well enough to UDCA or cannot take it, seladelpar (Livdelzi) and elafibranor (Iqirvo) have FDA accelerated approval based on ALP results, and both have confirmatory outcome trials underway. Linerixibat (Lynavoy), approved in March 2026, treats the itch of PBC rather than the liver disease itself. No head-to-head trial has compared seladelpar with elafibranor.