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  1. pharmadog
  2. ›drugs
  3. ›Livdelzi
drug
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seladelpar lysine

Marketedupdated 5mo ago
by CymaBay Therapeutics Inc
Approved
community read0 votes

🐶 often sniffed alongside

top 3
  • drugLIVDELZI8 co-mentions · 2 sources
  • tagApproval8 co-mentions · 2 sources
  • tagSmall Molecule4 co-mentions · 2 sources

Small molecule drug with a maximum clinical stage of Approval, with an approval for biliary liver cirrhosis.

all catalysts(2)

approval · 2
Aug 14, 2024
approval
$GILD152.21+0.85%
2y ago
LIVDELZI (SELADELPAR LYSINE) — FDA approval
seladelpar lysine
→
Jan 30, 2026
approval
$GILD152.21+0.85%
8mo ago
LIVDELZI (SELADELPAR LYSINE) — FDA approval
seladelpar lysine
→

Patent cliff

source: FDA Orange Book
first barrier falls
Aug 14, 2029
~2.9 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (6)

  • Mar 19, 2035method-of-use (U-1854)US 10272058
  • Mar 19, 2035method-of-use (U-1854)US 11406611
  • Mar 19, 2035method-of-use (U-1854)US 11596614
  • Mar 19, 2035method-of-use (U-1854)US 9486428
  • Sep 13, 2026compositionUS 7709682
  • Aug 2, 2026compositionUS 7301050

FDA exclusivities (2)

  • Aug 14, 2031ODE-486Orphan Drug (7y)4.9y
  • Aug 14, 2029NCENew Chemical Entity (5y)2.9y

News(1)

  • CEO O’Day tells Fierce how Gilead’s cancer, inflammation expansion has reached ‘critical mass’
    Following a steady stream of acquisitions that culminated in three biotech buyouts earlier this year, Gilead has now reached “critical mass” in its efforts to diversify into oncology and inflammati…
    fiercebiotech · 19d ago
brand
Livdelzi
generic
seladelpar lysine
MOA
12.1 Mechanism of Action Seladelpar is a peroxisome proliferator-activated receptor (PPAR)-delta (δ) agonist. However, the mechanism by which seladelpar exerts its therapeutic effects in patients with PBC is not well understood. Pharmacological activity that is potentially relevant to therapeutic effects includes inhibition of bile acid synthesis through activation of PPARδ, which is a nuclear receptor expressed in most tissues, including the liver. Published studies show that PPARδ activation by seladelpar reduces bile acid synthesis through Fibroblast Growth Factor 21 (FGF21)-dependent downregulation of CYP7A1, the key enzyme for the synthesis of bile acids from cholesterol.
indication
Primary Biliary Cholangitis (Primary Biliary Cirrhosis)
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 9m ago
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