deucravacitinib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| tyrosine kinase inhibitors | 5677 | 1609392-27-9 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Deucravacitinib is an inhibitor of tyrosine kinase 2 (TYK2). TYK2 is a member of the Janus kinase (JAK) family. Deucravacitinib binds to the regulatory domain of TYK2, stabilizing an inhibitory interaction between the regulatory and the catalytic domains of the enzyme. This results in allosteric inhibition of receptor-mediated activation of TYK2 and its downstream activation of Signal Transducers and Activators of Transcription (STATs) as shown in cell-based assays. JAK kinases, including TYK2, function as pairs of homo- or heterodimers in the JAK-STAT pathways. TYK2 pairs with JAK1 to mediate multiple cytokine pathways and also pairs with JAK2 to transmit signals as shown in cell-based assays. The precise mechanism linking inhibition of TYK2 enzyme to therapeutic effectiveness in the treatment of adults with moderate-to-severe plaque psoriasis is not currently known.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 24, 2023 | EMA | BRISTOL-MYERS SQUIBB PHARMA EEIG | |
| Sept. 9, 2022 | FDA | BRISTOL-MYERS SQUIBB | |
| Sept. 26, 2022 | PMDA | BRISTOL-MYERS SQUIBB K.K. |
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 |
|---|---|---|---|---|---|---|
| Acne | 209.51 | 76.42 | 42 | 267 | 23251 | 63465462 |
FDA Adverse Event Reporting System (Male)
None
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 |
|---|---|---|---|---|---|---|
| Acne | 179.24 | 80.62 | 38 | 349 | 27152 | 79716849 |
| Skin burning sensation | 112.95 | 80.62 | 23 | 364 | 13249 | 79730752 |
| Pruritus | 111.42 | 80.62 | 48 | 339 | 394600 | 79349401 |
| Erythema | 111.19 | 80.62 | 41 | 346 | 223249 | 79520752 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L04AA56 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Selective immunosuppressants |
| MeSH PA | D003879 | Dermatologic Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D047428 | Protein Kinase Inhibitors |
| FDA EPC | N0000194043 | Tyrosine Kinase 2 Inhibitor |
| FDA MoA | N0000194044 | Tyrosine Kinase 2 Inhibitors |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Plaque psoriasis | indication | 200965009 | |
| Pustular psoriasis | indication | 200973000 | |
| Erythrodermic psoriasis | indication | 200977004 | |
| Active tuberculosis | contraindication | 427099000 | |
| Severe active infection | contraindication |
🐶 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 6MG | SOTYKTU | BRISTOL | N214958 | Sept. 9, 2022 | RX | TABLET | ORAL | 11021475 | Nov. 7, 2033 | TREATMENT OF MODERATE-TO-SEVERE PLAQUE PSORIASIS IN ADULTS WHO ARE CANDIDATES FOR SYSTEMIC THERAPY OR PHOTOTHERAPY |
| 6MG | SOTYKTU | BRISTOL | N214958 | Sept. 9, 2022 | RX | TABLET | ORAL | RE47929 | Nov. 7, 2033 | TREATMENT OF MODERATE-TO-SEVERE PLAQUE PSORIASIS IN ADULTS WHO ARE CANDIDATES FOR SYSTEMIC THERAPY OR PHOTOTHERAPY |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 6MG | SOTYKTU | BRISTOL | N214958 | Sept. 9, 2022 | RX | TABLET | ORAL | Sept. 9, 2027 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Non-receptor tyrosine-protein kinase TYK2 | Kinase | INHIBITOR | IC50 | 9.70 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| Tyrosine-protein kinase JAK1 | Kinase | INHIBITOR | IC50 | 9 | SCIENTIFIC LITERATURE | ||||
| Bone morphogenetic protein receptor type-2 | Kinase | INHIBITOR | IC50 | 6.71 | SCIENTIFIC LITERATURE | ||||
| Non-receptor tyrosine-protein kinase TYK2 | Unclassified | IC50 | 7 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| CHEMBL4596392 | ChEMBL_ID |
| CHEMBL4435170 | ChEMBL_ID |
| C000628674 | MESH_SUPPLEMENTAL_RECORD_UI |
| 10432 | IUPHAR_LIGAND_ID |
| DB16650 | DRUGBANK_ID |
| 019177 | NDDF |
| 4041706 | VANDF |
| C5420928 | UMLSCUI |
| 11342 | INN_ID |
| D11817 | KEGG_DRUG |
| 134821691 | PUBCHEM_CID |
| 2612087 | RXNORM |
| 361718 | MMSL |
| 40933 | MMSL |
| d09921 | MMSL |
| N0A21N6RAU | UNII |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| SOTYKTU | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0003-0895 | TABLET, FILM COATED | 6 mg | ORAL | NDA | 28 sections |