Picato(ingenol mebutate)
Picato (ingenol mebutate) is a small molecule pharmaceutical. Ingenol mebutate was first approved as Picato on 2012-01-23. It is used to treat actinic keratosis in the USA. It has been approved in Europe to treat actinic keratosis. The pharmaceutical is active against protein kinase C delta type. In addition, it is known to target protein kinase C beta type, protein kinase C alpha type, protein kinase C epsilon type, and protein kinase C gamma type.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| skin and connective tissue diseases | D017437 |
Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ingenol mebutate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PICATO | LEO Pharma | N-202833 DISCN | 2012-01-23 | 2 products, RLD |
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FDA
EMA
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| actinic keratosis | — | D055623 | L57.0 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Ingenol Mebutate, Picato, Leo Labs | |||
| 9789078 | 2033-05-15 | U-2138 | |
| 8278292 | 2027-07-06 | DP | |
| 8372827 | 2026-12-18 | DP | |
| 8372828 | 2026-12-18 | DP | |
| 8377919 | 2026-12-18 | DP | |
| 8536163 | 2026-12-18 | U-1440 | |
| 8716271 | 2026-12-18 | U-1440 | |
| 8735375 | 2026-12-18 | U-1440 | |
| 9820959 | 2026-12-18 | DP | U-1440 |
| 9833428 | 2026-12-18 | DP | |
| 9833429 | 2026-12-18 | DP | |
| 9861603 | 2026-12-18 | U-1440 | |
HCPCS
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Clinical
Clinical Trials
72 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Actinic keratosis | D055623 | — | L57.0 | 15 | 12 | 14 | 8 | 10 | 57 |
| Keratosis | D007642 | — | — | 15 | 12 | 14 | 8 | 10 | 57 |
Indications Phases 3
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoma | D002277 | — | C80.0 | 1 | 7 | — | — | — | 7 |
| Basal cell carcinoma | D002280 | — | — | 1 | 6 | — | — | — | 6 |
| Basal cell neoplasms | D018295 | — | — | 1 | 3 | — | — | — | 3 |
| Warts | D014860 | — | B07 | 2 | 1 | — | — | — | 3 |
| Neoplasms | D009369 | — | C80 | — | 1 | — | — | — | 1 |
| Cheilitis | D002613 | HP_0100825 | K13.0 | 1 | 1 | — | — | — | 1 |
| Hutchinson's melanotic freckle | D018327 | — | — | — | 1 | — | — | — | 1 |
| Lentigo | D007911 | — | L81.4 | — | 1 | — | — | — | 1 |
| Condylomata acuminata | D003218 | EFO_0007147 | A63.0 | — | 1 | — | — | — | 1 |
| Seborrheic keratosis | D017492 | EFO_0005584 | L82 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| Molluscum contagiosum | D008976 | EFO_0007375 | B08.1 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Skin aging | D015595 | EFO_0005422 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ingenol mebutate |
| INN | ingenol mebutate |
| Description | Ingenol mebutate is a tetracyclic diterpenoid ester obtained by formal condensation of the carboxy group of (2Z)-2-methylbut-2-enoic (angelic) acid with the 3-hydroxy group of ingenol. Used for the topical treatment of actinic keratosis. It has a role as an antineoplastic agent. It is a tetracyclic diterpenoid, a carboxylic ester and a cyclic terpene ketone. It is functionally related to an angelic acid and an ingenol. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C/C=C(/C)C(=O)O[C@H]1C(C)=C[C@]23C(=O)[C@@H](C=C(CO)[C@@H](O)[C@]12O)[C@H]1[C@@H](C[C@H]3C)C1(C)C |
Identifiers
| PDB | — |
| CAS-ID | 75567-37-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1863513 |
| ChEBI ID | — |
| PubChem CID | 6918670 |
| DrugBank | DB05013 |
| UNII ID | 7686S50JAH (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
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Safety
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Adverse Events
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5,198 adverse events reported
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