Chemistry:Trifarotene

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Short description: Chemical compound
Trifarotene
Trifarotene.svg
Clinical data
Trade namesAklief
Other namesCD5789
AHFS/Drugs.comMonograph
MedlinePlusa620004
License data
Pregnancy
category
  • Contraindicated
Routes of
administration
Topical
Drug classSkin and mucous membrane agents
ATC code
Legal status
Legal status
Identifiers
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC29H33NO4
Molar mass459.586 g·mol−1
3D model (JSmol)

Trifarotene, sold under the brand name Aklief, is a medication for the topical treatment of acne vulgaris.[5][6] It is a retinoid;[5][7] specifically, a fourth-generation selective retinoic acid receptor (RAR)-γ agonist.[8]

Trifarotene was granted orphan drug designation for the treatment of congenital ichthyosis by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).[9][10] It was approved for medical use in the United States in October 2019.[6][11][12] In December 2019, its labelling and package leaflet text received a decentralised approval for 16 European countries.[13]

Medical uses

In the United States, trifarotene is indicated for the topical treatment of acne vulgaris in people nine years of age and older.[5] 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

Legal status

Trifarotene was approved for medical use in the United States in October 2019,[12] in Canada in November 2019,[3] and in Australia in January 2021.[1][2]

References

  1. 1.0 1.1 1.2 1.3 "Trifarotene Product Information". https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2021-PI-01076-1. 
  2. 2.0 2.1 2.2 2.3 "Aklief". 28 January 2021. https://www.tga.gov.au/apm-summary/aklief. 
  3. 3.0 3.1 3.2 https://pdf.hres.ca/dpd_pm/00054047.PDF [bare URL PDF]
  4. "Summary Basis of Decision (SBD) for Aklief". 23 October 2014. https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00464&lang=en. 
  5. 5.0 5.1 5.2 5.3 "Aklief- trifarotene cream". https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=62d910db-85a6-4696-b69b-4bd2f3080cfc. 
  6. 6.0 6.1 "Drug Trials Snapshots: Aklief". 11 October 2019. https://www.fda.gov/drugs/resources-information-approved-drugs/drug-trials-snapshots-aklief.  This article incorporates text from this source, which is in the public domain.
  7. "Trifarotene Monograph for Professionals". 28 October 2019. https://www.drugs.com/monograph/trifarotene.html. 
  8. "Trifarotene: First Approval". Drugs 79 (17): 1905–09. November 2019. doi:10.1007/s40265-019-01218-6. PMID 31713811. http://link.springer.com/10.1007/s40265-019-01218-6. 
  9. "Trifarotene Orphan Drug Designations and Approvals". 24 December 1999. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=20144310. 
  10. "EU/3/20/2264". 12 August 2020. https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3202264. 
  11. "Aklief (trifarotene) FDA Approval History". 7 October 2019. https://www.drugs.com/history/aklief.html. 
  12. 12.0 12.1 "Drug Approval Package: Aklief". October 21, 2019. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211527Orig1s000TOC.cfm. 
  13. "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 – via Business Wire.

External links