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Trifarotene

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Trifarotene
Clinical data
Trade namesAklief
Other namesCD5789
AHFS/Drugs.comMonograph
MedlinePlusa620004
License data
Pregnancy
category
Routes of
administration
Topical
Drug classSkin and mucous membrane agents
ATC code
Legal status
Legal status
Identifiers
  • 4-[3-(3-tert-Butyl-4-pyrrolidin-1-ylphenyl)-4-(2-hydroxyethoxy)phenyl]benzoic acid
CAS Number
PubChemCID
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
CompTox Dashboard(EPA)
ECHA InfoCard100.278.901Edit this at Wikidata
Chemical and physical data
FormulaC29H33NO4
Molar mass459.586g·mol−1
3D model (JSmol)
  • CC(C)(C)c1cc(-c2cc(-c3ccc(C(=O)O)cc3)ccc2OCCO)ccc1N1CCCC1
  • InChI=1S/C29H33NO4/c1-29(2,3)25-19-23(10-12-26(25)30-14-4-5-15-30)24-18-22(11-13-27(24)34-17-16-31)20-6-8-21(9-7-20)28(32)33/h6-13,18-19,31H,4-5,14-17H2,1-3H3,(H,32,33)
  • Key:MFBCDACCJCDGBA-UHFFFAOYSA-N

Trifarotene,sold under the brand nameAklief,is amedicationfor thetopical treatmentofacne vulgaris.[6][8]It is aretinoid;[6][9]specifically, a fourth-generation selectiveretinoic acid receptor (RAR)-γagonist.[10]

Trifarotene was grantedorphan drugdesignation for the treatment of congenitalichthyosisby both the U.S.Food and Drug Administration(FDA) and theEuropean Medicines Agency(EMA).[11][12]It was approved for medical use in the United States in October 2019.[8][13][14]In December 2019, its labelling and package leaflet text received a decentralised approval for 16 European countries.[7]

Medical uses[edit]

In the United States, trifarotene isindicatedfor the topical treatment of acne vulgaris in people nine years of age and older.[6]In both Canada and Australia, it is indicated for the topical treatment of acne vulgaris of the face and/or the trunk in people twelve years of age and older.[1][2][3]

Society and culture[edit]

Legal status[edit]

Trifarotene was approved for medical use in the United States in October 2019,[14]in Canada in November 2019,[3]and in Australia in January 2021.[1][2]

References[edit]

  1. ^abcd"Trifarotene Product Information".Therapeutic Goods Administration(TGA).Archivedfrom the original on 23 May 2021.Retrieved23 May2021.
  2. ^abcd"Aklief".Therapeutic Goods Administration (TGA).28 January 2021.Archivedfrom the original on 9 September 2021.Retrieved8 September2021.
  3. ^abc"PRODUCT MONOGRAPH Trifarotene cream"(PDF).Archived(PDF)from the original on 23 May 2021.Retrieved23 May2021.
  4. ^"Summary Basis of Decision (SBD) for Aklief".Health Canada.23 October 2014.Archivedfrom the original on 31 May 2022.Retrieved29 May2022.
  5. ^"Aklief Summary of Product Characteristics (SmPC)".(emc).28 November 2022.Archivedfrom the original on 6 August 2023.Retrieved5 July2024.
  6. ^abcd"Aklief- trifarotene cream".DailyMed.Archivedfrom the original on 23 May 2021.Retrieved22 May2021.
  7. ^ab"Galderma receives a positive outcome through the European Decentralised Procedure for Aklief (trifarotene 50 mcg/g cream), the first new retinoid molecule for acne in the European Union in 25 years"(Press release). Galderma. 20 December 2019.Archivedfrom the original on 24 May 2021.Retrieved24 May2021– via Business Wire.
  8. ^ab"Drug Trials Snapshots: Aklief".U.S.Food and Drug Administration(FDA).11 October 2019.Archivedfrom the original on 19 November 2019.Retrieved18 November2019.Public DomainThis article incorporates text from this source, which is in thepublic domain.
  9. ^"Trifarotene Monograph for Professionals".Drugs.com.28 October 2019.Archivedfrom the original on 4 March 2021.Retrieved23 May2021.
  10. ^Scott LJ (November 2019)."Trifarotene: First Approval".Drugs.79(17): 1905–09.doi:10.1007/s40265-019-01218-6.PMID31713811.S2CID207964653.Archivedfrom the original on 29 August 2021.Retrieved17 June2020.
  11. ^"Trifarotene Orphan Drug Designations and Approvals".U.S.Food and Drug Administration(FDA).24 December 1999.Archivedfrom the original on 29 August 2021.Retrieved19 August2020.
  12. ^"EU/3/20/2264".European Medicines Agency(EMA).12 August 2020.Archivedfrom the original on 9 January 2021.Retrieved19 August2020.
  13. ^"Aklief (trifarotene) FDA Approval History".Drugs.com.7 October 2019.Archivedfrom the original on 27 October 2020.Retrieved19 November2019.
  14. ^ab"Drug Approval Package: Aklief".U.S.Food and Drug Administration(FDA).21 October 2019.Archivedfrom the original on 19 November 2019.Retrieved18 November2019.