Chemistry:Trifarotene
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| Clinical data | |
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| Trade names | Aklief |
| Other names | CD5789 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a620004 |
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| Pregnancy category | |
| Routes of administration | Topical |
| Drug class | Skin and mucous membrane agents |
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| 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
- ↑ 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.
- ↑ 2.0 2.1 2.2 2.3 "Aklief". 28 January 2021. https://www.tga.gov.au/apm-summary/aklief.
- ↑ 3.0 3.1 3.2 https://pdf.hres.ca/dpd_pm/00054047.PDF [bare URL PDF]
- ↑ "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.
- ↑ 5.0 5.1 5.2 5.3 "Aklief- trifarotene cream". https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=62d910db-85a6-4696-b69b-4bd2f3080cfc.
- ↑ 6.0 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.
- ↑ "Trifarotene Monograph for Professionals". 28 October 2019. https://www.drugs.com/monograph/trifarotene.html.
- ↑ "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.
- ↑ "Trifarotene Orphan Drug Designations and Approvals". 24 December 1999. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=20144310.
- ↑ "EU/3/20/2264". 12 August 2020. https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3202264.
- ↑ "Aklief (trifarotene) FDA Approval History". 7 October 2019. https://www.drugs.com/history/aklief.html.
- ↑ 12.0 12.1 "Drug Approval Package: Aklief". October 21, 2019. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211527Orig1s000TOC.cfm.
- ↑ "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). https://druginfo.nlm.nih.gov/drugportal/name/trifarotene.
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