Trifarotene

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Trifarotene
Clinical data
Trade namesAklief, Selgamis
Other namesCD5789
AHFS/Drugs.comMonograph
MedlinePlusa620004
License data
Pregnancy
category
Routes of
administration		Topical
Drug classSkin and mucous membrane agents
ATC code
Legal status
Legal status
Identifiers
  • 4-[3-(3-tert-Butyl-4-pyrrolidin-1-ylphenyl)-4-(2-hydroxyethoxy)phenyl]benzoic acid
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
CompTox Dashboard (EPA)
ECHA InfoCard100.278.901 Edit this at Wikidata
Chemical and physical data
FormulaC29H33NO4
Molar mass459.586 g·mol−1
3D model (JSmol)
  • CC(C)(C)c1cc(-c2cc(-c3ccc(C(=O)O)cc3)ccc2OCCO)ccc1N1CCCC1
  • InChI=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)
  • Key:MFBCDACCJCDGBA-UHFFFAOYSA-N

Trifarotene, sold under the brand name Aklief, is a medication for the topical treatment of acne vulgaris.[6][8] It is a retinoid;[6][9] specifically, a fourth-generation selective retinoic acid receptor (RAR)-γ agonist.[10]

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).[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

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In the United States, trifarotene is indicated for 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]

Side effects

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Most adverse effects of topical trifarotene for the treatment of acne are at the location side and transient, such as application site irritation, allergic dermatitis, skin irritation and sunburn[15]. Even though systemic absorption is very low[16], use of trifarotene is still contraindicated during pregnancy[17] because of the known risk of teratogenicity of the overall class of drugs trifarotene belongs to, retinoids.

Society and culture

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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

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  1. ^ a b c d "Trifarotene Product Information". Therapeutic Goods Administration (TGA). Archived from the original on 23 May 2021. Retrieved 23 May 2021.
  2. ^ a b c d "Aklief". Therapeutic Goods Administration (TGA). 28 January 2021. Archived from the original on 9 September 2021. Retrieved 8 September 2021.
  3. ^ a b c "PRODUCT MONOGRAPH Trifarotene cream" (PDF). Archived (PDF) from the original on 23 May 2021. Retrieved 23 May 2021.
  4. ^ "Summary Basis of Decision (SBD) for Aklief". Health Canada. 23 October 2014. Archived from the original on 31 May 2022. Retrieved 29 May 2022.
  5. ^ "Aklief Summary of Product Characteristics (SmPC)". (emc). 28 November 2022. Archived from the original on 6 August 2023. Retrieved 5 July 2024.
  6. ^ a b c d "Aklief- trifarotene cream". DailyMed. Archived from the original on 23 May 2021. Retrieved 22 May 2021.
  7. ^ a b "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. Archived from the original on 24 May 2021. Retrieved 24 May 2021 – via Business Wire.
  8. ^ 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. Public Domain This article incorporates text from this source, which is in the public domain.
  9. ^ "Trifarotene Monograph for Professionals". Drugs.com. 28 October 2019. Archived from the original on 4 March 2021. Retrieved 23 May 2021.
  10. ^ Scott LJ (November 2019). "Trifarotene: First Approval". Drugs. 79 (17): 1905–09. doi:10.1007/s40265-019-01218-6. PMID 31713811. S2CID 207964653. Archived from the original on 29 August 2021. Retrieved 17 June 2020.
  11. ^ "Trifarotene Orphan Drug Designations and Approvals". U.S. Food and Drug Administration (FDA). 24 December 1999. Archived from the original on 29 August 2021. Retrieved 19 August 2020.
  12. ^ "EU/3/20/2264". European Medicines Agency (EMA). 12 August 2020. Archived from the original on 9 January 2021. Retrieved 19 August 2020.
  13. ^ "Aklief (trifarotene) FDA Approval History". Drugs.com. 7 October 2019. Archived from the original on 27 October 2020. Retrieved 19 November 2019.
  14. ^ 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.
  15. ^ Tan J, Thiboutot D, Popp G, Gooderham M, Lynde C, Del Rosso J, et al. (June 2019). "Randomized phase 3 evaluation of trifarotene 50 μg/g cream treatment of moderate facial and truncal acne". Journal of the American Academy of Dermatology. 80 (6): 1691–1699. doi:10.1016/j.jaad.2019.02.044. PMID 30802558.
  16. ^ Wagner N, Benkali K, Alió Sáenz A, Poncet M, Graeber M (May 2020). "Clinical Pharmacology and Safety of Trifarotene, a First-in-Class RARγ-Selective Topical Retinoid". Journal of Clinical Pharmacology. 60 (5): 660–668. doi:10.1002/jcph.1566. PMC 7187247. PMID 32017149.
  17. ^ "Trifarotene for acne". Australian Prescriber. 44 (4): 140–141. August 2021. doi:10.18773/austprescr.2021.033. PMC 8377295. PMID 34421181.


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