Seladelpar was approved for medical use in the United States in August 2024.[9][10][11]
Medical uses
Seladelpar is indicated 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.[3]
Clinically, seladelpar reduces pruritus (itching) and interleukin-31 in people with primary biliary cholangitis.[12]
Society and culture
Legal status
Seladelpar was approved for medical use in the United States in August 2024.[9] The FDA granted the application breakthrough therapy designation.[13]
In December 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency (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.[4] The applicant for this medicinal product is Gilead Sciences Ireland UC.[4] Seladelpar was authorized for medical use in the European Union in February 2025.[4][5] Seladelpar Gilead was renamed to Lyvdelzi.[4][5]
123456"Seladelpar Gilead EPAR". European Medicines Agency (EMA). 12 December 2024. Retrieved 16 December 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
1234"Seladelpar Gilead PI". Union Register of medicinal products. 21 February 2025. Retrieved 27 February 2025.
↑Billin AN (October 2008). "PPAR-beta/delta agonists for Type 2 diabetes and dyslipidemia: an adopted orphan still looking for a home". Expert Opinion on Investigational Drugs. 17 (10): 1465–1471. doi:10.1517/13543784.17.10.1465. PMID18808307. S2CID86564263.
↑"International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information. 31 (1). 2017. hdl:10665/330984.
