ingenol mebutate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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
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 | 796.77 | 120.17 | 111 | 1109 | 1244 | 50602660 |
| Application site erythema | 683.78 | 120.17 | 114 | 1106 | 4424 | 50599480 |
| Application site pain | 457.75 | 120.17 | 79 | 1141 | 3719 | 50600185 |
| Incorrect product administration duration | 447.34 | 120.17 | 89 | 1131 | 9186 | 50594718 |
| Product administered at inappropriate site | 254.64 | 120.17 | 45 | 1175 | 2398 | 50601506 |
| Application site scab | 251.35 | 120.17 | 32 | 1188 | 160 | 50603744 |
| Application site swelling | 244.74 | 120.17 | 35 | 1185 | 463 | 50603441 |
| Application site exfoliation | 179.05 | 120.17 | 25 | 1195 | 274 | 50603630 |
| Application site discharge | 159.32 | 120.17 | 21 | 1199 | 143 | 50603761 |
| Application site pustules | 134.70 | 120.17 | 15 | 1205 | 14 | 50603890 |
| Application site reaction | 129.65 | 120.17 | 21 | 1199 | 653 | 50603251 |
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 | 283.10 | 197.12 | 46 | 484 | 2053 | 29571944 |
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 | 528.36 | 127.88 | 87 | 972 | 4602 | 64493071 |
| Application site vesicles | 441.25 | 127.88 | 63 | 996 | 1259 | 64496414 |
| Application site pain | 395.36 | 127.88 | 67 | 992 | 4181 | 64493492 |
| Incorrect product administration duration | 309.42 | 127.88 | 62 | 997 | 9696 | 64487977 |
| Application site scab | 260.99 | 127.88 | 32 | 1027 | 177 | 64497496 |
| Application site exfoliation | 237.58 | 127.88 | 31 | 1028 | 300 | 64497373 |
| Product administered at inappropriate site | 214.01 | 127.88 | 38 | 1021 | 3072 | 64494601 |
| Squamous cell carcinoma of skin | 206.52 | 127.88 | 46 | 1013 | 11830 | 64485843 |
| Application site swelling | 193.16 | 127.88 | 28 | 1031 | 614 | 64497059 |
| Application site pustules | 147.42 | 127.88 | 16 | 1043 | 20 | 64497653 |
| Squamous cell carcinoma | 136.98 | 127.88 | 34 | 1025 | 13835 | 64483838 |
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 agents |
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 |
| C008125 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7443 | IUPHAR_LIGAND_ID |
| 9006 | INN_ID |
| 30220-46-3 | SECONDARY_CAS_RN |
| DB05013 | DRUGBANK_ID |
| 7686S50JAH | UNII |
| 6918670 | PUBCHEM_CID |
| 442042 | PUBCHEM_CID |
| 1242806 | RXNORM |
| 187013 | MMSL |
| 28281 | MMSL |
| 014146 | NDDF |
| 710279008 | SNOMEDCT_US |
| 715552008 | SNOMEDCT_US |
| C2825682 | UMLSCUI |
| C0063537 | UMLSCUI |
| CHEMBL2165402 | ChEMBL_ID |
| IC77UZI9G8 | UNII |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Picato | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50222-502 | GEL | 150 ug | TOPICAL | NDA | 26 sections |
| Picato | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50222-503 | GEL | 500 ug | TOPICAL | NDA | 26 sections |