Ritlecitinib

Clinical data
Trade names	Litfulo
Other names	PF-06651600
AHFS/Drugs.com	Monograph
MedlinePlus	a624015
License data	US DailyMed: Ritlecitinib
Pregnancy category	AU: D[1]
Routes of administration	By mouth
ATC code	L04AF08 (WHO)
Legal status
Legal status	AU: S4 (Prescription only)[2][1] CA: ℞-only[3][4][5] US: ℞-only[6] EU: Rx-only[7][8]
Identifiers
IUPAC name 1-[(2S,5R)-2-methyl-5-(7H-pyrrolo[2,3-d]pyrimidin-4-ylamino)piperidin-1-yl]prop-2-en-1-one
CAS Number	1792180-81-4 as salt: 2192215-81-7
PubChem CID	118115473
IUPHAR/BPS	9559
DrugBank	DB14924 as salt: DBSALT003482
ChemSpider	59718512 as salt: 81368003
UNII	2OYE00PC25 as salt: EAG4T1459K
KEGG	as salt: D11970
ChEBI	CHEBI:229233
ChEMBL	ChEMBL4085457
Chemical and physical data
Formula	C15H19N5O
Molar mass	285.351 g·mol−1
3D model (JSmol)	Interactive image
SMILES C[C@H]1CC[C@H](CN1C(=O)C=C)NC2=C3C=CNC3=NC=N2
InChI InChI=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 Key:CBRJPFGIXUFMTM-WDEREUQCSA-N Key:YOZLVAFWYLSRRN-VZXYPILPSA-N

Ritlecitinib, sold under the brand name Litfulo, is a medication used for the treatment of severe alopecia areata (hair loss).^[6] Ritlecitinib is a kinase inhibitor which inhibits Janus kinase 3 and tyrosine kinase.^[6][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,^[6][11][12] in the European Union in September 2023,^[7] and in Canada in November 2023.^[4]

Ritlecitinib is indicated for the treatment of severe alopecia areata for individuals twelve years of age and older.^[6][7]

The US Food and Drug Administration (FDA) approved ritlecitinib based on evidence from a clinical trial of 718 participants with severe alopecia areata.^[11] 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.^[11] The trial randomized 130 participants to ritlecitinib 50 mg once daily, 131 participants to placebo, and 457 participants to other ritlecitinib dosing regimens.^[11] 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.^[11] 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.^[11]

In 2023, ritlecitinib was approved for medical use in the United States,^[6][11] in the European Union,^[7] and in Canada.^[4]

The annual list price of ritlecitinib is US$49,000.^[13]

• Clinical trial number NCT03732807 for "PF-06651600 for the Treatment of Alopecia Areata (ALLEGRO-2b/3)" at ClinicalTrials.gov