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| Clinical data | |
|---|---|
| Trade names | Aklief |
| Other names | CD5789 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a620004 |
| License data |
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| Pregnancy category | |
| Routes of administration | Topical |
| Drug class | Skin and mucous membrane agents |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
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| CAS Number | |
| PubChem CID | |
| DrugBank | |
| ChemSpider | |
| UNII | |
| KEGG | |
| ChEMBL | |
| CompTox Dashboard (EPA) | |
| ECHA InfoCard | 100.278.901 |
| Chemical and physical data | |
| Formula | C29H33NO4 |
| Molar mass | 459.586 g·mol−1 |
| 3D model (JSmol) | |
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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
- ^ a b c d "Trifarotene Product Information". Therapeutic Goods Administration (TGA). Retrieved 23 May 2021.
- ^ a b c d "Aklief". Therapeutic Goods Administration (TGA). 28 January 2021. Retrieved 8 September 2021.
- ^ a b c https://pdf.hres.ca/dpd_pm/00054047.PDF[bare URL PDF]
- ^ "Summary Basis of Decision (SBD) for Aklief". Health Canada. 23 October 2014. Retrieved 29 May 2022.
- ^ a b c d "Aklief- trifarotene cream". DailyMed. Retrieved 22 May 2021.
- ^ a b "Drug Trials Snapshots: Aklief". U.S. Food and Drug Administration (FDA). 11 October 2019. Archived from the original on 19 November 2019. Retrieved 18 November 2019.
This article incorporates text from this source, which is in the public domain.
- ^ "Trifarotene Monograph for Professionals". Drugs.com. 28 October 2019. Retrieved 23 May 2021.
- ^ Scott LJ (November 2019). "Trifarotene: First Approval". Drugs. 79 (17): 1905–09. doi:10.1007/s40265-019-01218-6. PMID 31713811. S2CID 207964653.
- ^ "Trifarotene Orphan Drug Designations and Approvals". U.S. Food and Drug Administration (FDA). 24 December 1999. Retrieved 19 August 2020.
- ^ "EU/3/20/2264". European Medicines Agency (EMA). 12 August 2020. Retrieved 19 August 2020.
- ^ "Aklief (trifarotene) FDA Approval History". Drugs.com. 7 October 2019. Retrieved 19 November 2019.
- ^ a b "Drug Approval Package: Aklief". U.S. Food and Drug Administration (FDA). 21 October 2019. Archived from the original on 19 November 2019. Retrieved 18 November 2019.
- ^ "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
- "Trifarotene". Drug Information Portal. U.S. National Library of Medicine (NLM).
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This page was last edited on 30 January 2024, at 13:41