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tapinarof 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5521 | 79338-84-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Tapinarof is an aryl hydrocarbon receptor (AhR) agonist. The specific mechanisms by which VTAMA cream exerts its therapeutic action in psoriasis patients are unknown.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2A,ACVR2B,ACVRL1,AKT1,AKT2,AKT3,ALK,AURKA,AURKB,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK1,CDK4,CDK5,CDK9,CHEK1,CSF1R,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GRK3,GSK3B,ITK,JAK1,JAK2,JAK3,KIT,MAP2K6,MAP3K1,MAP3K10,MAP3K11,MAP3K14,MAP3K21,MAP3K7,MAP4K1,MAP4K3,MAPK10,MAPK12,MAPK14,MAPK7,MAPK9,MAPKAPK2,MAPKAPK5,MARK4,MET,MTOR,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CA,PIK3CB,PIK3CD,PIK3CG,PIM1,PIM2,PRKCD,PRKDC,SGK1,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ULK1,ULK2,ZAP70 | 78 | |||
| kinase-selectivity-class | ACVR2B,AXL,DDR1,EPHB4,ERBB2,GRK2,MAP2K6,MAPK7,SIK2,STK33 | 10 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 23, 2022 | FDA | DERMAVANT SCIENCES 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 |
|---|---|---|---|---|---|---|
| Dermatitis contact | 166.80 | 51.67 | 34 | 602 | 13561 | 90614250 |
| Folliculitis | 127.30 | 51.67 | 49 | 587 | 204304 | 90423507 |
| Pruritus | 54.24 | 51.67 | 38 | 598 | 541487 | 90086324 |
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 |
|---|---|---|---|---|---|---|
| Folliculitis | 523.43 | 80.87 | 85 | 466 | 5473 | 42615311 |
| Application site folliculitis | 174.62 | 80.87 | 17 | 534 | 0 | 42620784 |
| Dermatitis contact | 164.55 | 80.87 | 31 | 520 | 4472 | 42616312 |
| Milia | 108.19 | 80.87 | 13 | 538 | 78 | 42620706 |
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 |
|---|---|---|---|---|---|---|
| Dermatitis contact | 105.77 | 48.71 | 23 | 666 | 13930 | 110574680 |
| Application site folliculitis | 87.94 | 48.71 | 8 | 681 | 0 | 110588610 |
| Folliculitis | 79.26 | 48.71 | 32 | 657 | 167621 | 110420989 |
| Erythema | 59.41 | 48.71 | 31 | 658 | 291416 | 110297194 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | D05AX07 | DERMATOLOGICALS ANTIPSORIATICS ANTIPSORIATICS FOR TOPICAL USE Other antipsoriatics for topical use |
| MeSH PA | D003879 | Dermatologic Agents |
| FDA EPC | N0000194018 | Aryl Hydrocarbon Receptor Agonist |
| FDA MoA | N0000194019 | Aryl Hydrocarbon Receptor Agonists |
Related Drugs by ATC class:
D05AX Other antipsoriatics for topical use 7 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Plaque psoriasis | indication | 200965009 |
🐶 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 1% | VTAMA | ORGANON LLC | N215272 | May 23, 2022 | RX | CREAM | TOPICAL | 10426743 | May 19, 2036 | TOPICAL TREATMENT OF ATOPIC DERMATITIS IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER |
| 1% | VTAMA | ORGANON LLC | N215272 | May 23, 2022 | RX | CREAM | TOPICAL | 10426743 | May 19, 2036 | TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS |
| 1% | VTAMA | ORGANON LLC | N215272 | May 23, 2022 | RX | CREAM | TOPICAL | 11612573 | May 19, 2036 | TOPICAL TREATMENT OF ATOPIC DERMATITIS IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER |
| 1% | VTAMA | ORGANON LLC | N215272 | May 23, 2022 | RX | CREAM | TOPICAL | 11612573 | May 19, 2036 | TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS |
| 1% | VTAMA | ORGANON LLC | N215272 | May 23, 2022 | RX | CREAM | TOPICAL | 11497718 | Nov. 13, 2039 | TOPICAL TREATMENT OF ATOPIC DERMATITIS IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER |
| 1% | VTAMA | ORGANON LLC | N215272 | May 23, 2022 | RX | CREAM | TOPICAL | 11590088 | Nov. 13, 2039 | TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS |
| 1% | VTAMA | ORGANON LLC | N215272 | May 23, 2022 | RX | CREAM | TOPICAL | 11938099 | Nov. 13, 2039 | TOPICAL TREATMENT OF ATOPIC DERMATITIS IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER |
| 1% | VTAMA | ORGANON LLC | N215272 | May 23, 2022 | RX | CREAM | TOPICAL | 12569453 | Dec. 18, 2039 | TOPICAL TREATMENT OF ATOPIC DERMATITIS IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 1% | VTAMA | ORGANON LLC | N215272 | May 23, 2022 | RX | CREAM | TOPICAL | May 23, 2027 | NEW CHEMICAL ENTITY |
| 1% | VTAMA | ORGANON LLC | N215272 | May 23, 2022 | RX | CREAM | TOPICAL | Dec. 12, 2027 | TREATMENT OF ATOPIC DERMATITIS IN ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Aryl hydrocarbon receptor | Transcription factor | AGONIST | EC50 | 9.80 | SCIENTIFIC LITERATURE |
External reference:
| ID | Source |
|---|---|
| CHEBI:215747 | CHEBI |
| CHEMBL259571 | ChEMBL_ID |
| C571829 | MESH_SUPPLEMENTAL_RECORD_UI |
| 9686 | IUPHAR_LIGAND_ID |
| DB06083 | DRUGBANK_ID |
| 4041457 | VANDF |
| C4541381 | UMLSCUI |
| A1LWH | PDB_CHEM_ID |
| D11365 | KEGG_DRUG |
| 10253 | INN_ID |
| 6439522 | PUBCHEM_CID |
| 359272 | MMSL |
| 40699 | MMSL |
| 019085 | NDDF |
| 84HW7D0V04 | UNII |
| 2602286 | RXNORM |
| 84HW7D0V04 | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| VTAMA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 81672-5051 | CREAM | 10 mg | TOPICAL | NDA | 25 sections |