All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

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
Molfile Inchi Smiles Synonyms: tapinarof vtama GSK2894512 DMVT-505 WBI-1001	Tapinarof is an aryl hydrocarbon receptor (AhR) agonist. The specific mechanisms by which VTAMA cream exerts its therapeutic action in psoriasis patients are unknown. Molecular weight: 254.33 Formula: C17H18O2 CLOGP: 4.39 LIPINSKI: 0 HAC: 2 HDO: 2 TPSA: 40.46 ALOGS: -3.87 ROTB: 3 Status: ONP 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

calcipotrienecalcitriolfumaric acidroflumilasttacalcitoltazaroteneulobetasol propionate

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	P35869	AHR_HUMAN	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