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Drug ReportsRitlecitinib
Litfulo(ritlecitinib)
Litfulo (ritlecitinib) is a small molecule pharmaceutical. Ritlecitinib was first approved as Litfulo on 2023-06-23. It is used to treat alopecia areata in the USA. It has been approved in Europe to treat alopecia areata.
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YTD
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FDA approval date
EMA approval date
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Study first post date
Last update post date
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Litfulo
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ritlecitinib tosylate
Tradename
Company
Number
Date
Products
LITFULOPfizerN-215830 RX2023-06-23
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
litfuloNew Drug Application2024-07-16
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
alopecia areataEFO_0004192D000506L63
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
47 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Alopecia areataD000506EFO_0004192L63142—410
AlopeciaD000505HP_0002293L64142—410
VitiligoD014820EFO_0004208L80—13——4
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Rheumatoid arthritisD001172EFO_0000685M06.9—2———2
ArthritisD001168HP_0001369M05-M14—2———2
Crohn diseaseD003424EFO_0000384K50—1———1
Ulcerative colitisD003093EFO_0000729K51—1———1
ColitisD003092EFO_0003872K52.9—1———1
UlcerD014456MPATH_579——1———1
Diabetes mellitusD003920HP_0000819E08-E13—1———1
Type 1 diabetes mellitusD003922EFO_0001359E10—1———1
Celiac diseaseD002446EFO_0001060K90.0—1———1
MycosesD009181—B35-B49—1———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———23————23
Renal insufficiencyD051437HP_0000083N191————1
Liver diseasesD008107HP_0002910K70-K771————1
Hepatic insufficiencyD048550——1————1
PharmacokineticsD010599——1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRitlecitinib
INNritlecitinib
Description
Ritlecitinib is a pyrrolopyrimidine that is 7H-pyrrolo[2,3-d]pyrimidine substituted at position 4 by a [(3R,6S)-6-methyl-1-(prop-2-enoyl)piperidin-3-yl]amino group. It is a dual inhibitor of Janus kinase 3 and the TEC family of tyrosine kinases. It has a role as an EC 2.7.10.2 (non-specific protein-tyrosine kinase) inhibitor, an antirheumatic drug, an anti-inflammatory drug and an immunosuppressive agent. It is a pyrrolopyrimidine, a N-acylpiperidine, a secondary amino compound, a member of acrylamides and a tertiary carboxamide. It is a conjugate base of a ritlecitinib(1+).
Classification
Small molecule
Drug class—
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
C=CC(=O)N1C[C@H](Nc2ncnc3[nH]ccc23)CC[C@@H]1C
Identifiers
PDB—
CAS-ID1792180-81-4
RxCUI—
ChEMBL IDCHEMBL4085457
ChEBI ID—
PubChem CID118115473
DrugBankDB14924
UNII ID2OYE00PC25 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
No data
Safety
Black-box Warning
Black-box warning for: Litfulo
Adverse Events
Top Adverse Reactions
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709 adverse events reported
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