Ritlecitinib
{{Short description|Medication to treat hair loss}}
{{Use American English|date=June 2023}}
{{Use dmy dates|date=March 2024}}
{{cs1 config |name-list-style=vanc |display-authors=6}}
{{Infobox drug
| image = Ritlecitinib.svg
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| pronounce =
| tradename = Litfulo
| Drugs.com = {{drugs.com|monograph|ritlecitinib}}
| MedlinePlus = a624015
| DailyMedID = Ritlecitinib
| pregnancy_AU = D
| pregnancy_category =
| routes_of_administration = By mouth
| class =
| ATC_prefix = L04
| ATC_suffix = AF08
| ATC_supplemental =
| legal_AU = S4
| legal_AU_comment = https://www.tga.gov.au/resources/prescription-medicines-registrations/litfulo-pfizer-australia-pty-ltd{{cite web | title=Litfulo (ritlecitinib) | website=Therapeutic Goods Administration (TGA) | date=30 July 2024 | url=https://www.tga.gov.au/resources/auspmd/litfulo-ritlecitinib | access-date=12 October 2024}}
| legal_BR =
| legal_BR_comment =
| legal_CA = Rx-only
| legal_CA_comment = {{cite web | title=Litfulo Product information | website=Health Canada | date=13 February 2024 | url=https://dhpp.hpfb-dgpsa.ca/dhpp/resource/103199 | access-date=3 March 2024}}{{cite web | title=Summary Basis of Decision for Litfulo | website=Health Canada | date=18 July 2024 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1721405092068 | access-date=28 August 2024}}{{cite web | title=Regulatory Decision Summary for Litfulo | website=Health Canada | date=29 November 2023 | url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1710791169293 | access-date=2 April 2024}}
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| legal_US = Rx-only
| legal_EU = Rx-only
| legal_EU_comment = {{cite web | title=Litfulo EPAR | website=European Medicines Agency | date=18 September 2023 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/litfulo | access-date=20 September 2023 | archive-date=19 September 2023 | archive-url=https://web.archive.org/web/20230919155005/https://www.ema.europa.eu/en/medicines/human/EPAR/litfulo | url-status=live }}{{cite web | title=Litfulo Product information | website=Union Register of medicinal products | date=18 September 2023 | url=https://ec.europa.eu/health/documents/community-register/html/h1755.htm | access-date=1 October 2023 | archive-date=1 October 2023 | archive-url=https://web.archive.org/web/20231001223324/https://ec.europa.eu/health/documents/community-register/html/h1755.htm | url-status=live }}
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| index2_label = as salt
| CAS_number = 1792180-81-4
| CAS_number2 = 2192215-81-7
| CAS_supplemental =
| PubChem = 118115473
| IUPHAR_ligand = 9559
| DrugBank = DB14924
| DrugBank2 = DBSALT003482
| ChemSpiderID = 59718512
| ChemSpiderID2 = 81368003
| UNII = 2OYE00PC25
| UNII2 = EAG4T1459K
| KEGG =
| KEGG2 = D11970
| ChEBI = 229233
| ChEMBL = 4085457
| NIAID_ChemDB =
| PDB_ligand =
| synonyms = PF-06651600
| IUPAC_name = 1-[(2S,5R)-2-methyl-5-(7H-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
| StdInChI_comment =
| StdInChIKey = CBRJPFGIXUFMTM-WDEREUQCSA-N
| StdInChIKey2 = YOZLVAFWYLSRRN-VZXYPILPSA-N
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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.{{cite web | title=Ritlecitinib | website=Inxight Drugs | url=https://drugs.ncats.io/drug/2OYE00PC25 | access-date=24 June 2023 | archive-date=25 June 2023 | archive-url=https://web.archive.org/web/20230625051310/https://drugs.ncats.io/drug/2OYE00PC25 | url-status=live }}{{cite journal | vauthors = Ramírez-Marín HA, Tosti A | title = Evaluating the Therapeutic Potential of Ritlecitinib for the Treatment of Alopecia Areata | journal = Drug Design, Development and Therapy | volume = 16 | issue = | pages = 363–374 | date = February 2022 | pmid = 35210753 | pmc = 8860347 | doi = 10.2147/DDDT.S334727 | doi-access = free }}
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.{{cite web | title=Drug Trials Snapshots: Litfulo | website=U.S. Food and Drug Administration | date=23 June 2023 | url=https://www.fda.gov/drugs/development-approval-process-drugs/drug-trials-snapshots-litfulo | archive-url=https://web.archive.org/web/20240405073315/https://www.fda.gov/drugs/development-approval-process-drugs/drug-trials-snapshots-litfulo | url-status=dead | archive-date=5 April 2024 | access-date=29 April 2024}} {{PD-notice}}
Ritlecitinib was approved for medical use in the United States in June 2023,{{cite press release | title=FDA Approves Pfizer's Litfulo (Ritlecitinib) for Adults and Adolescents With Severe Alopecia Areata | publisher=Pfizer | via=Business Wire | date=23 June 2023 | url=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 | access-date=24 June 2023 | archive-date=25 June 2023 | archive-url=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 | url-status=live }} 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
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References
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Further reading
{{refbegin}}
- {{cite journal | vauthors = Guttman-Yassky E, Pavel AB, Diaz A, Zhang N, Del Duca E, Estrada Y, King B, Banerjee A, Banfield C, Cox LA, Dowty ME, Page K, Vincent MS, Zhang W, Zhu L, Peeva E | title = Ritlecitinib and brepocitinib demonstrate significant improvement in scalp alopecia areata biomarkers | journal = The Journal of Allergy and Clinical Immunology | volume = 149 | issue = 4 | pages = 1318–1328 | date = April 2022 | pmid = 34863853 | doi = 10.1016/j.jaci.2021.10.036 | s2cid = 244824663 | doi-access = free }}
- {{cite journal | vauthors = King B, Zhang X, Harcha WG, Szepietowski JC, Shapiro J, Lynde C, Mesinkovska NA, Zwillich SH, Napatalung L, Wajsbrot D, Fayyad R, Freyman A, Mitra D, Purohit V, Sinclair R, Wolk R | title = Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b-3 trial | journal = Lancet | location = London, England | volume = 401 | issue = 10387 | pages = 1518–1529 | date = May 2023 | pmid = 37062298 | doi = 10.1016/S0140-6736(23)00222-2 | s2cid = 258114404 | url = https://escholarship.org/uc/item/4qw041s6 }}
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External links
- {{ClinicalTrialsGov|NCT03732807|PF-06651600 for the Treatment of Alopecia Areata (ALLEGRO-2b/3)}}
{{Immunosuppressants}}
{{Cytokine receptor modulators}}
{{Other dermatological preparations}}
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Category:Hair loss medications