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Ingenol Mebutate (Reference)
Ingenol mebutate is a protein kinase C (PKC) activator that induces rapid necrosis of treated cells and promotes immune-mediated clearance of actinic keratosis lesions.
Ingenol mebutate is a protein kinase C (PKC) activator that induces rapid necrosis of treated cells and promotes immune-mediated clearance of actinic keratosis lesions. Used for Actinic keratosis (field treatment on face or scalp).
At a glance
| Generic name | Ingenol Mebutate (Reference) |
|---|---|
| Also known as | Reference Listed Drug Product |
| Sponsor | Padagis LLC |
| Drug class | Protein kinase C (PKC) activator |
| Target | Protein kinase C (PKC) |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
Ingenol mebutate activates protein kinase C, leading to direct cytotoxic effects on keratinocytes and induction of local inflammation. This triggers both rapid necrosis of treated lesions and a delayed immune response that eliminates residual dysplastic cells in the surrounding skin, providing both immediate and sustained therapeutic benefit.
Approved indications
- Actinic keratosis (field treatment on face or scalp)
Common side effects
- Application site erythema
- Application site pain
- Application site edema
- Application site erosion
- Application site pruritus
Key clinical trials
- To Compare Safety and Efficacy of Perrigo's Drug Compared to an FDA Approved Drug in the Treatment of Actinic Keratosis (PHASE3)
- To Compare Safety and Efficacy of Perrigo's Drug Product Compared to an FDA Approved Drug Product in the Treatment of Actinic Keratosis (PHASE3)
- A Study of Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato Gel 0.05% in Subjects With Actinic Keratosis (PHASE3)
- An Equivalence Study of Generic Ingenol Mebutate Gel 0.015% and Picato Gel 0.015% in Subjects With Actinic Keratosis (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |