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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 |
|---|---|
|
Synonyms:
|
protein kinase C agonist and antineoplastic
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
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 | ACTIVATOR | EC50 | 8.33 | SCIENTIFIC LITERATURE | SCIENTIFIC LITERATURE | |||
| Protein kinase C gamma type | Kinase | ACTIVATOR | Ki | 9.79 | IUPHAR | ||||
| Protein kinase C beta type | Kinase | EC50 | 6.84 | SCIENTIFIC LITERATURE | |||||
| Protein kinase C alpha type | Kinase | EC50 | 6.20 | SCIENTIFIC LITERATURE | |||||
| Protein kinase C epsilon type | Kinase | EC50 | 8.96 | SCIENTIFIC LITERATURE | |||||
| Serine/threonine-protein kinase D1 | Kinase | 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