Trifarotene
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Clinical data | |
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Trade names | Aklief |
Other names | CD5789 |
AHFS/Drugs.com | Monograph |
MedlinePlus | a620004 |
License data | |
Pregnancy category | |
Routes of administration | Topical |
Drug class | Skin and mucous membrane agents |
ATC code | |
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CompTox Dashboard(EPA) | |
ECHA InfoCard | 100.278.901 |
Chemical and physical data | |
Formula | C29H33NO4 |
Molar mass | 459.586g·mol−1 |
3D model (JSmol) | |
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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]
- ^abcd"Trifarotene Product Information".Therapeutic Goods Administration(TGA).Archivedfrom the original on 23 May 2021.Retrieved23 May2021.
- ^abcd"Aklief".Therapeutic Goods Administration (TGA).28 January 2021.Archivedfrom the original on 9 September 2021.Retrieved8 September2021.
- ^abc"PRODUCT MONOGRAPH Trifarotene cream"(PDF).Archived(PDF)from the original on 23 May 2021.Retrieved23 May2021.
- ^"Summary Basis of Decision (SBD) for Aklief".Health Canada.23 October 2014.Archivedfrom the original on 31 May 2022.Retrieved29 May2022.
- ^"Aklief Summary of Product Characteristics (SmPC)".(emc).28 November 2022.Archivedfrom the original on 6 August 2023.Retrieved5 July2024.
- ^abcd"Aklief- trifarotene cream".DailyMed.Archivedfrom the original on 23 May 2021.Retrieved22 May2021.
- ^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.
- ^ab"Drug Trials Snapshots: Aklief".U.S.Food and Drug Administration(FDA).11 October 2019.Archivedfrom the original on 19 November 2019.Retrieved18 November2019.
This article incorporates text from this source, which is in thepublic domain.
- ^"Trifarotene Monograph for Professionals".Drugs.com.28 October 2019.Archivedfrom the original on 4 March 2021.Retrieved23 May2021.
- ^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.
- ^"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.
- ^"EU/3/20/2264".European Medicines Agency(EMA).12 August 2020.Archivedfrom the original on 9 January 2021.Retrieved19 August2020.
- ^"Aklief (trifarotene) FDA Approval History".Drugs.com.7 October 2019.Archivedfrom the original on 27 October 2020.Retrieved19 November2019.
- ^ab"Drug Approval Package: Aklief".U.S.Food and Drug Administration(FDA).21 October 2019.Archivedfrom the original on 19 November 2019.Retrieved18 November2019.