Ingenol mebutate
As of the edition of 20 October 2026, Ingenol mebutate is a small molecule: marketed, first approved in 2012 (US); acts on PRKCD; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2012
- Kind
- Small molecule
- Brand name
- Picato
- First approved
- 23 January 2012 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- LEO Pharma
- Withdrawn from market
- 1 January 2020 (in some regions)
- Registered trials
- 53, 3 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Infections; Urinary and reproductive
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Ingenol mebutate.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| PRKCD | Protein kinase C delta type | Q05655 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 7 | 7 | 0 | 0 |
| Phase 1 | 14 | 12 | 0 | 2 |
| Phase 2 | 21 | 19 | 0 | 1 |
| Phase 3 | 8 | 8 | 0 | 0 |
| Phase 4 | 3 | 3 | 0 | 0 |
| All trials | 53 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| LEO Pharma | Originator, Applicant and Lead sponsor of trials | 2011 to now |