Ritlecitinib Explained

Tradename:Litfulo
Dailymedid:Ritlecitinib
Pregnancy Au:D
Routes Of Administration:By mouth
Atc Prefix:L04
Atc Suffix:AF08
Legal Au:S4
Legal Au Comment:[1] [2]
Legal Ca:Rx-only
Legal Ca Comment:[3] [4] [5]
Legal Us:Rx-only
Legal Us Comment:[6]
Legal Eu:Rx-only
Legal Eu Comment:[7] [8]
Index2 Label:as salt
Cas Number:1792180-81-4
Cas Number2:2192215-81-7
Pubchem:118115473
Iuphar Ligand:9559
Drugbank:DB14924
Drugbank2:DBSALT003482
Chemspiderid:59718512
Chemspiderid2:81368003
Unii:2OYE00PC25
Unii2:EAG4T1459K
Kegg2:D11970
Chebi:229233
Chembl:4085457
Synonyms:PF-06651600
Iupac Name:1-[(2''S'',5''R'')-2-methyl-5-(7''H''-pyrrolo[2,3-d]pyrimidin-4-ylamino)piperidin-1-yl]prop-2-en-1-one
C:15
H:19
N:5
O:1
Smiles:C[C@H]1CC[C@H](CN1C(=O)C=C)NC2=C3C=CNC3=NC=N2
Stdinchi:1S/C15H19N5O/c1-3-13(21)20-8-11(5-4-10(20)2)19-15-12-6-7-16-14(12)17-9-18-15/h3,6-7,9-11H,1,4-5,8H2,2H3,(H2,16,17,18,19)/t10-,11+/m0/s1
Stdinchikey:CBRJPFGIXUFMTM-WDEREUQCSA-N
Stdinchikey2:YOZLVAFWYLSRRN-VZXYPILPSA-N

Ritlecitinib, sold under the brand name Litfulo, is a medication used for the treatment of severe alopecia areata (hair loss). Ritlecitinib is a kinase inhibitor which inhibits Janus kinase 3 and tyrosine kinase.[9] [10]

The most common side effects include headache, diarrhea, acne, rashes, eczema, fever, mouth ulcers, dizziness, shingles rash, and abnormal findings in some laboratory test results.[11]

Ritlecitinib was approved for medical use in the United States in June 2023,[12] in the European Union in September 2023, and in Canada in November 2023.

Medical uses

Ritlecitinib is indicated for the treatment of severe alopecia areata for individuals twelve years of age and older.

History

The US Food and Drug Administration (FDA) approved ritlecitinib based on evidence from a clinical trial of 718 participants with severe alopecia areata. The efficacy and safety of ritlecitinib were evaluated in a randomized, double-blind, placebo controlled trial in 718 participants twelve years of age and older with alopecia areata with ≥50% scalp hair loss, including alopecia totalis and alopecia universalis. The trial randomized 130 participants to ritlecitinib 50 mg once daily, 131 participants to placebo, and 457 participants to other ritlecitinib dosing regimens. The safety evaluation was also supported by two placebo-controlled trials in which 80 participants were randomized to ritlecitinib 200 mg once daily for four weeks followed by 50 mg once daily and 82 participants were randomized to placebo. The trial was conducted at 128 sites in 18 countries in Argentina, Australia, Canada, Chile, China, Colombia, Czech Republic, Germany, Hungary, Japan, Republic of Korea, Mexico, Poland, Russian Federation, Spain, Taiwan, the United Kingdom, and the United States.

Society and culture

Legal status

In 2023, ritlecitinib was approved for medical use in the United States, in the European Union, and in Canada.

Economics

The annual list price of ritlecitinib is .[13]

Further reading

Notes and References

  1. https://www.tga.gov.au/resources/prescription-medicines-registrations/litfulo-pfizer-australia-pty-ltd
  2. Web site: Litfulo (ritlecitinib) . Therapeutic Goods Administration (TGA) . 30 July 2024 . 12 October 2024.
  3. Web site: Litfulo Product information . . 13 February 2024 . 3 March 2024.
  4. Web site: Summary Basis of Decision for Litfulo . . 18 July 2024 . 28 August 2024.
  5. Web site: Regulatory Decision Summary for Litfulo . . 29 November 2023 . 2 April 2024.
  6. Web site: Litfulo- ritlecitinib capsule . DailyMed . U.S. National Library of Medicine . 23 June 2023 . 28 August 2023 . 29 August 2023 . https://web.archive.org/web/20230829050849/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6b2f9446-fb23-4741-b73a-5a2f993733c3 . live .
  7. Web site: Litfulo EPAR . . 18 September 2023 . 20 September 2023 . 19 September 2023 . https://web.archive.org/web/20230919155005/https://www.ema.europa.eu/en/medicines/human/EPAR/litfulo . live .
  8. Web site: Litfulo Product information . Union Register of medicinal products . 18 September 2023 . 1 October 2023 . 1 October 2023 . https://web.archive.org/web/20231001223324/https://ec.europa.eu/health/documents/community-register/html/h1755.htm . live .
  9. Web site: Ritlecitinib . Inxight Drugs . 24 June 2023 . 25 June 2023 . https://web.archive.org/web/20230625051310/https://drugs.ncats.io/drug/2OYE00PC25 . live .
  10. Ramírez-Marín HA, Tosti A . Evaluating the Therapeutic Potential of Ritlecitinib for the Treatment of Alopecia Areata . Drug Design, Development and Therapy . 16 . 363–374 . February 2022 . 35210753 . 8860347 . 10.2147/DDDT.S334727 . free .
  11. Web site: Drug Trials Snapshots: Litfulo . U.S. Food and Drug Administration . 23 June 2023 . 29 April 2024.
  12. FDA Approves Pfizer's Litfulo (Ritlecitinib) for Adults and Adolescents With Severe Alopecia Areata . Pfizer . Business Wire . 23 June 2023 . 24 June 2023 . 25 June 2023 . https://web.archive.org/web/20230625051309/https://www.businesswire.com/news/home/20230623087591/en/FDA-Approves-Pfizer%E2%80%99s-LITFULO%E2%84%A2-Ritlecitinib-for-Adults-and-Adolescents-With-Severe-Alopecia-Areata . live .
  13. Web site: Kansteiner F . 26 June 2023 . Pfizer's Litfulo enters the scene in alopecia with adolescent nod to rival Lilly's Olumiant . Fierce Pharma . 18 September 2023 . 8 July 2023 . https://web.archive.org/web/20230708164950/https://www.fiercepharma.com/pharma/pfizers-litfulo-enters-scene-alopecia-adolescent-nod-rival-lillys-olumiant . live .

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