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ritlecitinib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| Janus kinase inhibitors, antineoplastics | 5728 | 1792180-81-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Ritlecitinib irreversibly inhibits Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) kinase family by blocking the adenosine triphosphate (ATP) binding site. In cellular settings, ritlecitinib inhibits cytokine induced STAT phosphorylation mediated by JAK3-dependent receptors. Additionally, ritlecitinib inhibits signaling of immune receptors dependent on TEC kinase family members. The relevance of inhibition of specific JAK or TEC family enzymes to therapeutic effectiveness is not currently known.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 50 | mg | O |
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2B,AURKA,BLK,BMX,BTK,CAMK2D,CHEK2,CSNK1G2,DDR1,DYRK1B,EGFR,EIF2AK3,ERBB2,ERBB4,GRK2,ITK,JAK3,MAP3K10,MAP3K21,MAPK3,MARK4,PDK1,PDK2,PDK4,RIPK3,STK33 | 26 | |||
| kinase-selectivity-class | AURKA,BLK,BMX,BTK,CLK2,EGFR,ERBB2,ERBB4,JAK3,MAP3K10,MAP3K21,PDK1 | 12 | |||
| mdck-mdr1-bcrp-efflux | MDCK-MDR1-BCRP efflux ratio | 8.933 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| rat-kpuu-brain | Rat brain Kpuu | 0.039 | % | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| June 23, 2023 | FDA | PFIZER INC | |
| Sept. 15, 2023 | EMA | PFIZER EUROPE MA EEIG | |
| June 26, 2023 | PMDA | Pfizer Japan Inc. |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Drug ineffective | 157.50 | 44.91 | 116 | 735 | 1384182 | 89243414 |
| Therapeutic product effect incomplete | 142.95 | 44.91 | 57 | 794 | 193839 | 90433757 |
| Condition aggravated | 75.46 | 44.91 | 54 | 797 | 595491 | 90032105 |
| Acne | 66.77 | 44.91 | 20 | 831 | 28487 | 90599109 |
| Product dose omission issue | 44.99 | 44.91 | 30 | 821 | 291657 | 90335939 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Therapeutic product effect incomplete | 161.99 | 67.62 | 49 | 378 | 70890 | 42550018 |
| Drug ineffective | 147.38 | 67.62 | 84 | 343 | 630113 | 41990795 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Therapeutic product effect incomplete | 256.64 | 48.79 | 92 | 1005 | 223713 | 110364489 |
| Drug ineffective | 250.66 | 48.79 | 163 | 934 | 1520377 | 109067825 |
| Condition aggravated | 104.51 | 48.79 | 73 | 1024 | 734763 | 109853439 |
| Product dose omission issue | 75.40 | 48.79 | 44 | 1053 | 321738 | 110266464 |
| Acne | 75.01 | 48.79 | 23 | 1074 | 33497 | 110554705 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L04AF08 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Janus-associated kinase (JAK) inhibitors |
| MeSH PA | D000075242 | Janus Kinase Inhibitors |
| MeSH PA | D000092004 | Tyrosine Kinase Inhibitors |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D047428 | Protein Kinase Inhibitors |
| CHEBI has role | CHEBI:35472 | anti-inflammatory drug |
| CHEBI has role | CHEBI:35526 | hypoglycemic agent |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:35705 | immunosuppressive agent |
| CHEBI has role | CHEBI:35842 | antirheumatic drug |
| CHEBI has role | CHEBI:50177 | dermatologic drug |
| CHEBI has role | CHEBI:67079 | anti-inflammatory agent |
| CHEBI has role | CHEBI:76617 | EC 2.7.10.2 (non-specific protein-tyrosine kinase) inhibitor |
| CHEBI has role | CHEBI:231911 | renoprotective agent |
Related Drugs by ATC class:
L04AF Janus-associated kinase (JAK) inhibitors 7 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Alopecia areata | indication | 68225006 | DOID:986 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 50MG BASE | LITFULO | PFIZER | N215830 | June 23, 2023 | RX | CAPSULE | ORAL | 12077533 | Dec. 3, 2034 | METHOD OF TREATING SEVERE ALOPECIA AREATA IN ADULTS AND ADOLESCENTS 12 YEARS AND OLDER BY ADMINISTERING RITLECTINIB |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 50MG BASE | LITFULO | PFIZER | N215830 | June 23, 2023 | RX | CAPSULE | ORAL | June 23, 2028 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Tyrosine-protein kinase JAK3 | Kinase | INHIBITOR | IC50 | 7.48 | DRUG LABEL | DRUG LABEL | |||
| Receptor tyrosine-protein kinase erbB-4 | Kinase | IC50 | 4.60 | CHEMBL | |||||
| Cytoplasmic tyrosine-protein kinase BMX | Kinase | Ki | 6.26 | CHEMBL | |||||
| Tyrosine-protein kinase ITK/TSK | Kinase | Ki | 7.57 | CHEMBL | |||||
| Tyrosine-protein kinase JAK1 | Kinase | INHIBITOR | IC50 | 5.79 | IUPHAR | ||||
| Tyrosine-protein kinase Tec | Kinase | IC50 | 6.23 | CHEMBL | |||||
| Tyrosine-protein kinase TXK | Kinase | Ki | 6.88 | CHEMBL | |||||
| Tyrosine-protein kinase Blk | Kinase | IC50 | 4.72 | CHEMBL | |||||
| Tyrosine-protein kinase BTK | Kinase | IC50 | 6.22 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| CHEBI:229233 | CHEBI |
| CHEMBL4085457 | ChEMBL_ID |
| C000614924 | MESH_SUPPLEMENTAL_RECORD_UI |
| 9559 | IUPHAR_LIGAND_ID |
| DB14924 | DRUGBANK_ID |
| 2054121000122104 | SNOMEDCT_US |
| 42476811000001107 | SNOMEDCT_US |
| 4042382 | VANDF |
| C5418278 | UMLSCUI |
| CHEMBL5314649 | ChEMBL_ID |
| 11170 | INN_ID |
| 2192215-81-7 | SECONDARY_CAS_RN |
| 118115473 | PUBCHEM_CID |
| 368615 | MMSL |
| 41733 | MMSL |
| d10074 | MMSL |
| 019479 | NDDF |
| 019480 | NDDF |
| D11970 | KEGG_DRUG |
| 2OYE00PC25 | UNII |
| 2641595 | RXNORM |
| 2OYE00PC25 | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Litfulo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0069-0334 | CAPSULE | 50 mg | ORAL | NDA | 32 sections |
| Litfulo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63539-334 | CAPSULE | 50 mg | ORAL | NDA | 32 sections |