Seladelpar

Seladelpar
Clinical data
Trade names	Livdelzi
Other names	MBX-8025; RWJ-800025
AHFS/Drugs.com	Livdelzi
License data	US DailyMed: Seladelpar;
Routes of; administration	By mouth
ATC code	A05AX07 (WHO) ;
Legal status
Legal status	US: ℞-only;
Identifiers
	IUPAC name 2-[4-[(2R)-2-ethoxy-3-[4-(trifluoromethyl)phenoxy]propyl]sulfanyl-2-methylphenoxy]acetic acid;
CAS Number	851528-79-5;
PubChem CID	11236126;
DrugBank	DB12390;
ChemSpider	9411171;
UNII	7C00L34NB9;
KEGG	D11256;
ChEMBL	ChEMBL230158;
CompTox Dashboard (EPA)	DTXSID001045332 ;
Chemical and physical data
Formula	C21H23F3O5S
Molar mass	444.47 g·mol−1
3D model (JSmol)	Interactive image;
	SMILES CCO[C@H](COC1=CC=C(C=C1)C(F)(F)F)CSC2=CC(=C(C=C2)OCC(=O)O)C;
	InChI InChI=1S/C21H23F3O5S/c1-3-27-17(11-28-16-6-4-15(5-7-16)21(22,23)24)13-30-18-8-9-19(14(2)10-18)29-12-20(25)26/h4-10,17H,3,11-13H2,1-2H3,(H,25,26)/t17-/m1/s1; Key:JWHYSEDOYMYMNM-QGZVFWFLSA-N;

Seladelpar, sold under the brand name Livdelzi, is a medication used for the treatment of primary biliary cholangitis.^[1] It is used as the lysine dihydrate salt.^[1] It is a peroxisome proliferator-activated receptor delta (PPARδ) receptor agonist.^[1]^[2]^[3] The compound was licensed from Janssen Pharmaceutica NV.^[4]

Seladelpar was approved for medical use in the United States in August 2024.^[5]^[6]^[7]

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.^[1]

Clinically, seladelpar reduces pruritus (itching) and interleukin-31 in people with primary biliary cholangitis.^[8]

Society and culture

Legal status

Seladelpar was approved for medical use in the United States in August 2024.^[5] The FDA granted the application breakthrough therapy designation.^[9]

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.^[10] The applicant for this medicinal product is Gilead Sciences Ireland UC.^[10]

The EMA granted seladelpar orphan medicine designation.^[10]

Names

Seladelpar is the international nonproprietary name.^[11]

References

^ ^a ^b ^c ^d ^e "Livdelzi- seladelpar lysine capsule". DailyMed. 14 August 2024. Retrieved 5 September 2024.
^ 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. PMID 18808307. S2CID 86564263.
^ Bays HE, Schwartz S, Littlejohn T, Kerzner B, Krauss RM, Karpf DB, et al. (September 2011). "MBX-8025, a novel peroxisome proliferator receptor-delta agonist: lipid and other metabolic effects in dyslipidemic overweight patients treated with and without atorvastatin". The Journal of Clinical Endocrinology and Metabolism. 96 (9): 2889–2897. doi:10.1210/jc.2011-1061. PMID 21752880.
^ "Targeting Mixed Dyslipidemia and Metabolic Syndrome". Metabolex, Inc. 2005. Archived from the original on 17 October 2006.
^ ^a ^b "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 29 November 2024.
^ "Gilead's Livdelzi (Seladelpar) Granted Accelerated Approval for Primary Biliary Cholangitis by U.S. FDA" (Press release). Gilead. 14 August 2024. Retrieved 15 August 2024 – via Business Wire.
^ New Drug Therapy Approvals 2024 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025.
^ Kremer AE, Mayo MJ, Hirschfield GM, Levy C, Bowlus CL, Jones DE, et al. (July 2024). "Seladelpar treatment reduces IL-31 and pruritus in patients with primary biliary cholangitis". Hepatology. 80 (1): 27–37. doi:10.1097/HEP.0000000000000728. PMC 11191048. PMID 38117036.
^ "CY 2024 CDER Breakthrough Therapy Calendar Year Approvals" (PDF). U.S. Food and Drug Administration (FDA). 30 September 2024.
^ ^a ^b ^c "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.
^ World Health Organization (2017). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information. 31 (1). hdl:10665/330984.

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[Livdelzi_FDA_label-1] "Livdelzi- seladelpar lysine capsule". DailyMed. 14 August 2024. Retrieved 5 September 2024.

[pmid18808307-2] 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. PMID 18808307. S2CID 86564263.

[pmid21752880-3] Bays HE, Schwartz S, Littlejohn T, Kerzner B, Krauss RM, Karpf DB, et al. (September 2011). "MBX-8025, a novel peroxisome proliferator receptor-delta agonist: lipid and other metabolic effects in dyslipidemic overweight patients treated with and without atorvastatin". The Journal of Clinical Endocrinology and Metabolism. 96 (9): 2889–2897. doi:10.1210/jc.2011-1061. PMID 21752880.

[Metabolex2006-4] "Targeting Mixed Dyslipidemia and Metabolic Syndrome". Metabolex, Inc. 2005. Archived from the original on 17 October 2006.

[Novel_Drug_Approvals_for_2024-5] "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 29 November 2024.

[6] "Gilead's Livdelzi (Seladelpar) Granted Accelerated Approval for Primary Biliary Cholangitis by U.S. FDA" (Press release). Gilead. 14 August 2024. Retrieved 15 August 2024 – via Business Wire.

[7] New Drug Therapy Approvals 2024 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025.

[8] Kremer AE, Mayo MJ, Hirschfield GM, Levy C, Bowlus CL, Jones DE, et al. (July 2024). "Seladelpar treatment reduces IL-31 and pruritus in patients with primary biliary cholangitis". Hepatology. 80 (1): 27–37. doi:10.1097/HEP.0000000000000728. PMC 11191048. PMID 38117036.

[CY_2024_CDER_Breakthrough_Therapy_Calendar_Year_Approvals-9] "CY 2024 CDER Breakthrough Therapy Calendar Year Approvals" (PDF). U.S. Food and Drug Administration (FDA). 30 September 2024.

[Seladelpar_Gilead_EPAR-10] "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.

[11] World Health Organization (2017). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information. 31 (1). hdl:10665/330984.

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