Seladelpar, sold under the brand name Livdelzi, is a
medication
Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, medicinal drug or simply drug) is a drug used to medical diagnosis, diagnose, cure, treat, or preventive medicine, prevent disease. Drug therapy (pharmaco ...
used for the treatment of
primary biliary cholangitis.
It is used as the lysine dihydrate salt.
It is a
peroxisome proliferator-activated receptor delta
A peroxisome () is a membrane-bound organelle, a type of microbody, found in the cytoplasm of virtually all eukaryotic cells. Peroxisomes are oxidative organelles. Frequently, molecular oxygen serves as a co-substrate, from which hydrogen perox ...
(PPARĪ“)
receptor agonist
An agonist is a chemical that activates a receptor to produce a biological response. Receptors are cellular proteins whose activation causes the cell to modify what it is currently doing. In contrast, an antagonist blocks the action of the agon ...
.
The compound was licensed from
Janssen Pharmaceutica
Johnson & Johnson Innovative Medicine (formerly Janssen Pharmaceuticals) is a Belgian pharmaceutical company headquartered in Beerse, Belgium, and wholly owned by Johnson & Johnson. It was founded in 1953 by Paul Janssen.
In 1961, Janssen Ph ...
NV.
Seladelpar was approved for medical use in the United States in August 2024.
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Medical uses
Seladelpar is
indicated
In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis ...
for the treatment of primary biliary cholangitis in combination with
ursodeoxycholic acid in adults who have an inadequate response to ursodeoxycholic acid, or as
monotherapy in people unable to tolerate ursodeoxycholic acid.
Clinically, seladelpar reduces
pruritus (itching) and
interleukin-31 in people with primary biliary cholangitis.
Society and culture
Legal status
Seladelpar was approved for medical use in the United States in August 2024.
The FDA granted the application
breakthrough therapy designation.
In December 2024, the
Committee for Medicinal Products for Human Use of the
European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products ...
(EMA) adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Seladelpar Gilead, intended for the treatment of
primary biliary cholangitis.
The applicant for this medicinal product is Gilead Sciences Ireland UC.
[ Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.] Seladelpar was authorized for medical use in the European Union in February 2025.
Seladelpar Gilead was renamed to Lyvdelzi.
The EMA granted seladelpar
orphan medicine designation.
Names
Seladelpar is the
international nonproprietary name.
References
{{Authority control
Acetic acids
Ethoxy compounds
Orphan drugs
PPAR agonists
Thioethers
Trifluoromethyl compounds