Trifarotene Explained

Tradename:Aklief
Dailymedid:Trifarotene
Pregnancy Au:D
Pregnancy Category:Contraindicated
Routes Of Administration:Topical
Class:Skin and mucous membrane agents
Atc Prefix:D10
Atc Suffix:AD06
Legal Au:S4
Legal Au Comment:[1] [2]
Legal Ca:Rx-only
Legal Ca Comment:[3] [4]
Legal Uk:POM
Legal Uk Comment:[5]
Legal Us:Rx-only
Legal Us Comment:[6]
Legal Status:Rx-only
Cas Number:895542-09-3
Pubchem:11518241
Drugbank:DB12808
Chemspiderid:9693029
Unii:0J8RN2W0HK
Kegg:D11225
Chembl:3707313
Synonyms:CD5789
Iupac Name:4-[3-(3-''tert''-Butyl-4-pyrrolidin-1-ylphenyl)-4-(2-hydroxyethoxy)phenyl]benzoic acid
C:29
H:33
N:1
O:4
Smiles:CC(C)(C)c1cc(-c2cc(-c3ccc(C(=O)O)cc3)ccc2OCCO)ccc1N1CCCC1
Stdinchi: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)
Stdinchikey:MFBCDACCJCDGBA-UHFFFAOYSA-N

Trifarotene, sold under the brand name Aklief, is a medication for the topical treatment of acne vulgaris.[7] It is a retinoid;[8] specifically, a fourth-generation selective retinoic acid receptor (RAR)-γ agonist.[9]

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).[10] [11] It was approved for medical use in the United States in October 2019.[12] [13] In December 2019, its labelling and package leaflet text received a decentralised approval for 16 European countries.[14]

Medical uses

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

Society and culture

Legal status

Trifarotene was approved for medical use in the United States in October 2019, in Canada in November 2019, and in Australia in January 2021.

Notes and References

  1. Web site: Trifarotene Product Information . Therapeutic Goods Administration (TGA) . 23 May 2021 . 23 May 2021 . https://web.archive.org/web/20210523190514/https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2021-PI-01076-1 . live .
  2. Web site: Aklief . Therapeutic Goods Administration (TGA) . 28 January 2021 . 8 September 2021 . 9 September 2021 . https://web.archive.org/web/20210909014105/https://www.tga.gov.au/apm-summary/aklief . live .
  3. Web site: PRODUCT MONOGRAPH Trifarotene cream . 23 May 2021 . 23 May 2021 . https://web.archive.org/web/20210523220540/https://pdf.hres.ca/dpd_pm/00054047.PDF . live .
  4. Web site: Summary Basis of Decision (SBD) for Aklief . . 23 October 2014 . 29 May 2022 . 31 May 2022 . https://web.archive.org/web/20220531043601/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00464&lang=en . live .
  5. Web site: Aklief Summary of Product Characteristics (SmPC) . (emc) . 28 November 2022 . 5 July 2024 . 6 August 2023 . https://web.archive.org/web/20230806082849/https://www.medicines.org.uk/emc/product/13881 . live .
  6. Web site: Aklief- trifarotene cream . DailyMed . 22 May 2021 . 23 May 2021 . https://web.archive.org/web/20210523053819/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=62d910db-85a6-4696-b69b-4bd2f3080cfc . live .
  7. Web site: Drug Trials Snapshots: Aklief . U.S. Food and Drug Administration (FDA) . 11 October 2019 . https://web.archive.org/web/20191119042107/https://www.fda.gov/drugs/resources-information-approved-drugs/drug-trials-snapshots-aklief . 19 November 2019 . live . 18 November 2019.
  8. Web site: Trifarotene Monograph for Professionals . Drugs.com . 28 October 2019 . 23 May 2021 . 4 March 2021 . https://web.archive.org/web/20210304102410/https://www.drugs.com/monograph/trifarotene.html . live .
  9. Scott LJ . Trifarotene: First Approval . Drugs . 79 . 17 . 1905–09 . November 2019 . 31713811 . 10.1007/s40265-019-01218-6 . 207964653 . 17 June 2020 . 29 August 2021 . https://web.archive.org/web/20210829180337/https://link.springer.com/article/10.1007%2Fs40265-019-01218-6 . live .
  10. Web site: Trifarotene Orphan Drug Designations and Approvals . U.S. Food and Drug Administration (FDA) . 24 December 1999 . 19 August 2020 . 29 August 2021 . https://web.archive.org/web/20210829094902/https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=20144310 . live .
  11. Web site: EU/3/20/2264 . European Medicines Agency (EMA) . 12 August 2020 . 19 August 2020 . 9 January 2021 . https://web.archive.org/web/20210109125835/https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3202264 . live .
  12. Web site: Aklief (trifarotene) FDA Approval History . Drugs.com . 7 October 2019 . 19 November 2019 . 27 October 2020 . https://web.archive.org/web/20201027190832/https://www.drugs.com/history/aklief.html . live .
  13. Web site: Drug Approval Package: Aklief . U.S. Food and Drug Administration (FDA) . 21 October 2019 . https://web.archive.org/web/20191119042411/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211527Orig1s000TOC.cfm . 19 November 2019 . live . 18 November 2019.
  14. 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. Galderma. Business Wire. 20 December 2019. 24 May 2021. 24 May 2021. https://web.archive.org/web/20210524032944/https://www.businesswire.com/news/home/20191220005031/en/Galderma-receives-a-positive-outcome-through-the-European-Decentralised-Procedure-for-AKLIEF%C2%AE-trifarotene-50-mcgg-cream-the-first-new-retinoid-molecule-for-acne-in-the-European-Union-in-25-years1. live.

This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Trifarotene".

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