drug · small molecule

LIVDELZI

updated 3mo ago

by $GILD GILEAD SCIENCES, INC.🔗 ChEMBL

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

targets

Peroxisome proliferator-activated receptor delta

all catalysts(0)

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brand

LIVDELZI

trade names

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

1 INDICATIONS AND USAGE 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 (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). LIVDELZI is a peroxisome proliferator-activated receptor (PPAR)-delta agonist indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have 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). ( 1 ) Limitations of Use Use of LIVDELZI is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy). ( 8.7 ) Limitations of Use Use of LIVDELZI is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy) [see Use in Specific Populations (8.7) ] .

Data sources

ClinicalTrials.gov · OpenTargets

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drug · small molecule

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LIVDELZI

updated 3mo ago

by $GILD GILEAD SCIENCES, INC.🔗 ChEMBL

community read0 votes

🐶 often sniffed alongside

top 3

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

targets

Peroxisome proliferator-activated receptor delta

all catalysts(0)

nothing on the calendar yet

News(0)

no news has mentioned this drug yet

brand

LIVDELZI

trade names

Livdelzi

generic

SELADELPAR LYSINE

MOA

indication

Data sources

ClinicalTrials.gov · OpenTargets

last refreshed 30m ago

Found something off?

comments(0)

5-min edit window · permanent after that

no comments yet — first sniff?

LIVDELZI

🐶 often sniffed alongside

targets

all catalysts(0)

News(0)

Report a data issue

comments(0)

LIVDELZI

🐶 often sniffed alongside

targets

all catalysts(0)

News(0)

Report a data issue

comments(0)