Seladelpar

From Wikipedia, the free encyclopedia

Template:Short description Template:DMCA Template:Cs1 config Template:Short description Page Template:Infobox drug/styles.css has no content.

Page Module:Infobox/styles.css has no content.

Seladelpar
Lua error in package.lua at line 80: module 'Module:InfoboxImage/data' not found.
Clinical data
Pronunciation/ˌsɛləˈdɛlpɑːr/
Script error: No such module "Respell".
Trade namesLivdelzi, others
Other namesMBX-8025; RWJ-800025
AHFS/Drugs.comMonograph
MedlinePlusa624062
License dataPage Template:Plainlist/styles.css has no content.
Routes of
administration		By mouth
ATC codePage Template:Plainlist/styles.css has no content.
Legal status
Legal statusPage Template:Plainlist/styles.css has no content.
Identifiers
  • 2-[4-[(2R)-2-ethoxy-3-[4-(trifluoromethyl)phenoxy]propyl]sulfanyl-2-methylphenoxy]acetic acid
CAS NumberPage Template:Plainlist/styles.css has no content.
PubChem CIDPage Template:Plainlist/styles.css has no content.
PubChem SIDPage Template:Plainlist/styles.css has no content.
IUPHAR/BPSPage Template:Plainlist/styles.css has no content.
DrugBankPage Template:Plainlist/styles.css has no content.
ChemSpiderPage Template:Plainlist/styles.css has no content.
UNIIPage Template:Plainlist/styles.css has no content.
KEGGPage Template:Plainlist/styles.css has no content.
ChEBIPage Template:Plainlist/styles.css has no content.
ChEMBLPage Template:Plainlist/styles.css has no content.
NIAID ChemDBPage Template:Plainlist/styles.css has no content.
PDB ligandPage Template:Plainlist/styles.css has no content.
CompTox Dashboard (EPA)Page Template:Plainlist/styles.css has no content.
Chemical and physical data
FormulaC21H23F3O5S
Molar mass444.47 g·mol−1
3D model (JSmol)Page Template:Plainlist/styles.css has no content.
  • CCO[C@H](COC1=CC=C(C=C1)C(F)(F)F)CSC2=CC(=C(C=C2)OCC(=O)O)C
  • 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
Data page
Template:Infobox drug/data page link

Seladelpar, sold under the brand name Livdelzi, is a medication used for the treatment of primary biliary cholangitis.[3] It is used as the lysine dihydrate salt.[3] It is a peroxisome proliferator-activated receptor delta (PPARδ) receptor agonist.[3][6][7] The compound was licensed from Janssen Pharmaceutica NV.[8]

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

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]

The EMA granted seladelpar orphan medicine designation.[4][5]

Names

Seladelpar is the international nonproprietary name.[14]

References

Page Template:Reflist/styles.css has no content.

  1. ^ Page Module:Citation/CS1/styles.css has no content."Lyvdelzi Product information". Health Canada. 16 October 2025. Retrieved 8 November 2025.
  2. ^ Page Module:Citation/CS1/styles.css has no content."Summary Basis of Decision for Lyvdelzi". Drug and Health Products Portal. 1 September 2012. Retrieved 17 February 2026.
  3. ^ a b c d e Page Module:Citation/CS1/styles.css has no content."Livdelzi- seladelpar lysine capsule". DailyMed. 14 August 2024. Retrieved 5 September 2024.
  4. ^ a b c d e f Page Module:Citation/CS1/styles.css has no content."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.
  5. ^ a b c d Page Module:Citation/CS1/styles.css has no content."Seladelpar Gilead PI". Union Register of medicinal products. 21 February 2025. Retrieved 27 February 2025.
  6. ^ Page Module:Citation/CS1/styles.css has no content.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.
  7. ^ Page Module:Citation/CS1/styles.css has no content.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.
  8. ^ Page Module:Citation/CS1/styles.css has no content."Targeting Mixed Dyslipidemia and Metabolic Syndrome". Metabolex, Inc. 2005. Archived from the original on 17 October 2006.
  9. ^ a b Page Module:Citation/CS1/styles.css has no content."Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 1 October 2024. Archived from the original on 19 April 2024. Retrieved 29 November 2024.
  10. ^ Page Module:Citation/CS1/styles.css has no content."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.
  11. ^ Page Module:Citation/CS1/styles.css has no content.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.
  12. ^ Page Module:Citation/CS1/styles.css has no content.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.
  13. ^ Page Module:Citation/CS1/styles.css has no content."CY 2024 CDER Breakthrough Therapy Calendar Year Approvals" (PDF). U.S. Food and Drug Administration (FDA). 30 September 2024.
  14. ^ Page Module:Citation/CS1/styles.css has no content."International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information. 31 (1). 2017. hdl:10665/330984.

Lua error in package.lua at line 80: module 'Module:Navbox/configuration' not found. Template:PPAR modulators Lua error in mw.title.lua at line 404: bad argument #2 to 'title.new' (unrecognized namespace name 'Portal'). Lua error in package.lua at line 80: module 'Module:Authority control/config' not found.

Retrieved from "https://cosmopedia.co/index.php?title=Seladelpar&oldid=12127243"