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

ingenol mebutate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
	4226	75567-37-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: picato PEP005 Ingenol 3-angelate 3-Angeloylingenol 3-Ingenyl angelate ingenol mebutate	protein kinase C agonist and antineoplastic Molecular weight: 430.54 Formula: C25H34O6 CLOGP: 2.89 LIPINSKI: 0 HAC: 6 HDO: 3 TPSA: 104.06 ALOGS: -3.19 ROTB: 4 Status: OFM 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	ACVR2B,AURKA,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,EPHB4,ERBB2,GRK2,GSK3B,ITK,JAK2,JAK3,MAP2K6,MAP3K7,MAPK10,MAPK7,NTRK2,PDK1,PDK2,PDK4,PIK3CA,PIK3CB,PIK3CG,PIM2,PRKDC,STK33,SYK,TEK,TGFBR1,ZAP70	35
kinase-selectivity-class	GRK2,MAP2K6	2
pfas-class	PFAS structural alert (1 = True, 0 = False)	0

Approvals:

Date	Agency	Company	Orphan
Jan. 23, 2012	FDA	LEO PHARMA AS

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
Application site vesicles	848.53	119.58	111	1113	1406	90625817
Application site erythema	734.08	119.58	114	1110	5094	90622129
Application site pain	486.33	119.58	79	1145	4641	90622582
Incorrect product administration duration	433.61	119.58	89	1135	19233	90607990
Application site scab	270.22	119.58	32	1192	158	90627065
Product administered at inappropriate site	256.85	119.58	45	1179	4106	90623117
Application site swelling	255.85	119.58	35	1189	612	90626611
Application site exfoliation	184.05	119.58	25	1199	412	90626811
Application site discharge	170.24	119.58	21	1203	153	90627070
Application site pustules	142.39	119.58	15	1209	16	90627207
Application site reaction	137.44	119.58	21	1203	809	90626414

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
Application site erythema	290.22	170	46	489	2520	42618280
Application site scab	189.97	170	21	514	53	42620747
Application site pain	171.92	170	29	506	2300	42618500

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
Application site erythema	559.39	122.38	87	975	5523	110582714
Application site vesicles	464.44	122.38	63	999	1501	110586736
Application site pain	413.98	122.38	67	995	5432	110582805
Incorrect product administration duration	296.69	122.38	62	1000	20436	110567801
Application site scab	275.08	122.38	32	1030	198	110588039
Application site exfoliation	237.36	122.38	31	1031	539	110587698
Squamous cell carcinoma of skin	214.11	122.38	46	1016	17157	110571080
Product administered at inappropriate site	213.47	122.38	38	1024	5355	110582882
Application site swelling	199.12	122.38	28	1034	859	110587378
Application site pustules	155.14	122.38	16	1046	22	110588215
Squamous cell carcinoma	150.74	122.38	35	1027	18428	110569809

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	D06BX02	DERMATOLOGICALS ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE CHEMOTHERAPEUTICS FOR TOPICAL USE Other chemotherapeutics
FDA PE	N0000009176	Increased Cellular Death
FDA EPC	N0000184015	Cell Death Inducer
CHEBI has role	CHEBI:35610	antineoplastic agent

Related Drugs by ATC class:

D06BX Other chemotherapeutics 2 drugs

metronidazoletirbanibulin

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Actinic keratosis	indication	201101007	DOID:8866

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	11.14	acidic
pKa2	11.74	acidic
pKa3	13.75	acidic

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
0.015%	PICATO	LEO LABS	N202833	Jan. 23, 2012	DISCN	GEL	TOPICAL	8536163	Dec. 18, 2026	USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS
0.015%	PICATO	LEO LABS	N202833	Jan. 23, 2012	DISCN	GEL	TOPICAL	8716271	Dec. 18, 2026	USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS
0.015%	PICATO	LEO LABS	N202833	Jan. 23, 2012	DISCN	GEL	TOPICAL	8735375	Dec. 18, 2026	USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS
0.015%	PICATO	LEO LABS	N202833	Jan. 23, 2012	DISCN	GEL	TOPICAL	9820959	Dec. 18, 2026	USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS
0.015%	PICATO	LEO LABS	N202833	Jan. 23, 2012	DISCN	GEL	TOPICAL	9861603	Dec. 18, 2026	USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS
0.05%	PICATO	LEO LABS	N202833	Jan. 23, 2012	DISCN	GEL	TOPICAL	8536163	Dec. 18, 2026	USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS
0.05%	PICATO	LEO LABS	N202833	Jan. 23, 2012	DISCN	GEL	TOPICAL	8716271	Dec. 18, 2026	USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS
0.05%	PICATO	LEO LABS	N202833	Jan. 23, 2012	DISCN	GEL	TOPICAL	8735375	Dec. 18, 2026	USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS
0.05%	PICATO	LEO LABS	N202833	Jan. 23, 2012	DISCN	GEL	TOPICAL	9820959	Dec. 18, 2026	USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS
0.05%	PICATO	LEO LABS	N202833	Jan. 23, 2012	DISCN	GEL	TOPICAL	9861603	Dec. 18, 2026	USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS
0.015%	PICATO	LEO LABS	N202833	Jan. 23, 2012	DISCN	GEL	TOPICAL	9789078	May 15, 2033	TOPICAL TREATMENT OF ACTINIC KERATOSIS OF THE FACE OR SCALP USING MORE THAN ONE TREATMENT COURSE OF INGENOL MEBUTATE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Protein kinase C delta type	Kinase	Q05655	KPCD_HUMAN	ACTIVATOR	EC50	8.33		SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE
Protein kinase C gamma type	Kinase	P05129	KPCG_HUMAN	ACTIVATOR	Ki	9.79		IUPHAR
Protein kinase C beta type	Kinase	P05771	KPCB_HUMAN		EC50	6.84		SCIENTIFIC LITERATURE
Protein kinase C alpha type	Kinase	P17252	KPCA_HUMAN		EC50	6.20		SCIENTIFIC LITERATURE
Protein kinase C epsilon type	Kinase	Q02156	KPCE_HUMAN		EC50	8.96		SCIENTIFIC LITERATURE
Serine/threonine-protein kinase D1	Kinase	Q15139	KPCD1_HUMAN		EC50	7.52		SCIENTIFIC LITERATURE

External reference:

ID	Source
D09393	KEGG_DRUG
4031406	VANDF
4031407	VANDF
CHEBI:66913	CHEBI
WUD	PDB_CHEM_ID
CHEMBL1863513	ChEMBL_ID
C486592	MESH_SUPPLEMENTAL_RECORD_UI
7443	IUPHAR_LIGAND_ID
DB05013	DRUGBANK_ID
7686S50JAH	UNII
1242806	RXNORM
187013	MMSL
28281	MMSL
014146	NDDF
710279008	SNOMEDCT_US
715552008	SNOMEDCT_US
C2825682	UMLSCUI
C0063537	UMLSCUI
CHEMBL2165402	ChEMBL_ID
9006	INN_ID
6918670	PUBCHEM_CID
30220-46-3	SECONDARY_CAS_RN
442042	PUBCHEM_CID
C008125	MESH_SUPPLEMENTAL_RECORD_UI
IC77UZI9G8	UNII

Pharmaceutical products:

None