Treats primary biliary cholangitis (PBC). NDA 217899, held by Gilead Sciences Inc. Seladelpar Lysine.
As of Nov 14, 2026, NDA 217899 (Livdelzi), held by Gilead Sciences Inc, was first approved by FDA on Aug 14, 2024, with 1 approved supplement and 0 published complete response letters.
LIVDELZI is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. This indication is approved under accelerated approval based on a reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 14, 2024 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| LivdelziEQ 10MG BASE · capsule;oral | Seladelpar Lysine | RxReference drug |
| Jan 30, 2026 | Supplement 2Labeling · Standard review | Approved | |
| Aug 14, 2024 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
