Prescription medicine
Seladelpar lysine Brand names: Livdelzi
Seladelpar lysine (Livdelzi) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the seladelpar lysine FDA label on DailyMed (effective February 3, 2026, Gilead Sciences, Inc); the NDA 217899 record on Drugs@FDA; every seladelpar lysine label on DailyMed.
Highlights of the record
FDA label of February 3, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageLIVDELZI 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.
Forms and strengths
- 10 mg
Capsule.
On the market
- Earliest approval on file
- August 14, 2024 Livdelzi, Gilead Sciences Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 19, 2035 Livdelzi capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 229 through July 30, 2026
What is seladelpar lysine used for?
From the label: indications and usageLIVDELZI 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 (14) ]. 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). […]
Source: FDA drug label (Livdelzi), Gilead Sciences, Inc, effective February 3, 2026 (SPL set 89f79d98-135c-40b2-a585-6996c04e599c), via openFDA; the full label on DailyMed
Is there a generic for seladelpar lysine (Livdelzi)?
No generic seladelpar lysine is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 6 patents for Livdelzi capsules: the compound patent runs to September 13, 2027, and the last listed entry to March 19, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2024 earliest approval on file
- 2035 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the seladelpar lysine label say about other medicines?
The seladelpar lysine label names 4 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cyclosporine | drug interactions | Concomitant Drug or Class: Dual or Multiple Clinical Inhibitors of Drug Transporters OATP1B1, OATP1B3, and BCRP (e.g, cyclosporine); Potential Effect on Seladelpar Exposure ↑ = Increase, ↓ = Decrease.: ↑ seladelpar; … |
| Fluconazole | drug interactions | Concomitant Drug or Class: Dual Moderate CYP2C9 and Moderate or Strong CYP3A4 Inhibitors (e.g., fluconazole); Potential Effect on Seladelpar Exposure ↑ = Increase, ↓ = Decrease.: ↑ seladelpar; Clinical Intervention: Monitor patients for adverse effects during concomitant use of LIVDELZI with drugs that are dual … |
| Probenecid | drug interactions | DRUG INTERACTIONS Probenecid: Avoid concomitant use. ( 7.1 ) Strong CYP2C9 Inhibitors: Monitor for adverse effects. ( 7.1 ) Dual Moderate CYP2C9 and Moderate to Strong CYP3A4 Inhibitors: |
| Rifampin | drug interactions | Monitor for adverse effects. ( 7.1 ) Rifampin: Monitor biochemical response (e.g., ALP and bilirubin) when patients initiate rifampin. |
Source: FDA drug label (Livdelzi), Gilead Sciences, Inc, effective February 3, 2026 (SPL set 89f79d98-135c-40b2-a585-6996c04e599c), via openFDA; the full label on DailyMed
What do FAERS reports show for seladelpar lysine?
The FDA Adverse Event Reporting System holds 229 reports that list seladelpar lysine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 11 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Seladelpar lysine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other