NDAORALCAPSULEPriority Review
Approved
Aug 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
1
Data completeness
5/8 — Partial
Priority Review
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LIVDELZI (seladelpar lysine) is an oral small-molecule capsule approved by the FDA on August 14, 2024, for treatment of primary biliary cholangitis (PBC). The drug works as a farnesoid X receptor (FXR) agonist, targeting a key metabolic pathway in cholestatic liver disease. It represents a novel mechanistic approach to a rare, progressive autoimmune liver condition.
Growth8.9 years to LOE
Early-stage product in growth phase with limited commercial infrastructure; significant team expansion likely as market develops.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Started Sep 2023
318 enrolled
Primary Biliary Cholangitis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.