Iqirvo (elafibranor)

The first of 2 second-line PBC pills given FDA accelerated approval in 2024, followed by seladelpar (Livdelzi) in August 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.

PBC slowly destroys the small bile ducts in the liver, and the bile acids that back up damage liver cells. Elafibranor and its main active breakdown product switch on PPARs, a family of receptors that act as control switches for how the body handles fats and bile acids. In lab tests it activates the alpha, delta and gamma forms, and the label says its action on the alpha and delta forms is potentially the relevant one in PBC, by turning down the liver's production of bile acids. Exactly how it helps in PBC is not well understood. In the main trial it lowered alkaline phosphatase (ALP), a liver blood test that rises when bile flow is blocked, but it has not yet been shown to help people live longer or avoid liver failure.

Iqirvo has no boxed warning and no contraindications. In the main trial the most common side effects, against placebo, were weight gain (23% against 21%), diarrhea (11% against 9%), abdominal pain (11% against 6%), nausea (11% against 6%), vomiting (11% against 2%), joint pain (8% against 4%), constipation (8% against 2%) and muscle pain (7% against 2%). Fractures happened in 6% of people on elafibranor and in no one on placebo. The label warns about muscle injury, including 1 case of rhabdomyolysis (severe muscle breakdown) with kidney injury in a person with cirrhosis who was also taking a statin, and about drug-induced liver injury, allergic reactions and blocked bile ducts. Raised CPK, a muscle enzyme, was the most common reason people stopped treatment (4%). It may harm an unborn baby, and since August 2026 the label advises women who could become pregnant to avoid birth control containing ethinyl estradiol, because elafibranor can make it less effective, and to use another method during treatment and for 3 weeks after the last dose^[1][3].

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Approved for adults with PBC, taken with UDCA when UDCA alone has not worked well enough, or on its own when UDCA cannot be tolerated. Not recommended for people who have or develop decompensated cirrhosis. Safety and effectiveness in children have not been established. The main trial required ALP of at least 1.67 times the upper limit of normal and bilirubin no higher than 2 times normal.

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Approval rested on ELATIVE (NCT04526665), which randomized 161 adults with PBC who had not responded well enough to UDCA, or could not take it, to elafibranor 80 mg (108 people) or placebo (53 people) for at least 52 weeks, with 95% 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. At week 52 that goal was reached by 51% on elafibranor against 4% on placebo, and ALP came down to normal in 15% against 0%^[1][7]. In July 2026 Ipsen reported that a second trial, ELSPIRE, in people whose ALP was only mildly raised (1 to 1.67 times normal), met its main goal, with 85% reaching a normal ALP at week 52 against 23% on placebo; Ipsen plans to submit those results to regulators^[6].

Elafibranor was discovered by GENFIT under the code GFT505^[10], and Ipsen licensed the rights everywhere except mainland China, Hong Kong, Taiwan and Macau in 2021^[5]. The FDA granted accelerated approval as Iqirvo on June 10, 2024, based on the drop in ALP, and Ipsen described it as the first new PBC medicine in nearly a decade^[2][5]. The approval requires a confirmatory trial, ELFIDENCE (NCT06016842), measuring death, liver transplant, liver decompensation, worsening MELD scores and liver cancer, with completion planned for May 2029 under the timetable in the approval letter^[2][9]. On August 7, 2026, the FDA approved a label update based on a drug interaction study with birth control pills, changing the contraception advice, and recorded a related postmarketing requirement and commitment as fulfilled^[3]. As of September 29, 2026, Iqirvo is still marketed under accelerated approval and has not been withdrawn^[4].

UDCA remains the first treatment for PBC. For people who do not respond well enough to UDCA or cannot take it, elafibranor (Iqirvo) and seladelpar (Livdelzi) 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 elafibranor with seladelpar.