LIVDELZI (seladelpar lysine) · Gilead Sciences
LIVDELZI (seladelpar lysine) is a peroxisome proliferator-activated receptor (PPAR)-delta agonist indicated for the treatment of primary biliary cholangitis (PBC) in adult patients. It is used in combination with ursodeoxycholic acid (UDCA) for those with an inadequate response to UDCA, or as a monotherapy for patients who cannot tolerate UDCA. The drug received accelerated approval based on its ability to reduce alkaline phosphatase levels, though its impact on survival or the prevention of liver decompensation has not been established. Use is not recommended for patients who have or develop decompensated cirrhosis.
How LIVDELZI Works
Seladelpar is a peroxisome proliferator-activated receptor (PPAR)-delta agonist. While the exact mechanism by which it exerts its therapeutic effects in PBC is not fully understood, it is thought to reduce bile acid synthesis by downregulating CYP7A1—the rate-limiting enzyme in the conversion of cholesterol to bile acids. This downregulation is mediated through the activation of Fibroblast Growth Factor 21 (FGF21).
Details
- Status
- Prescription
- First Approved
- 2024-08-14
- Patent Cliff
- 2035
- Routes
- ORAL
- Dosage Forms
- CAPSULE
LIVDELZI Approval History
What LIVDELZI Treats
1 indicationsLIVDELZI is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Primary Biliary Cholangitis
LIVDELZI Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Other CDER-designated drugs from the same sponsor (2016–2025).
Active Pipeline
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LIVDELZI FDA Label Details
Indications & Usage
FDA Label (PDF)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) [see Clinical Studies ] . 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)....
LIVDELZI Patents & Exclusivity
Patents (6 active)
Exclusivity
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Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 6 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 1 similar drugs
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.