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ingenol mebutate 0.05% gel
Ingenol mebutate activates protein kinase C (PKC) to induce rapid necrosis of actinic keratosis cells and promote immune-mediated clearance of damaged skin.
Ingenol mebutate activates protein kinase C (PKC) to induce rapid necrosis of actinic keratosis cells and promote immune-mediated clearance of damaged skin. Used for Actinic keratosis (field treatment on face or scalp).
At a glance
| Generic name | ingenol mebutate 0.05% gel |
|---|---|
| Also known as | Picato®, Picato® gel |
| Sponsor | Neal D. Bhatia, MD |
| Drug class | Protein kinase C activator |
| Target | Protein kinase C (PKC) |
| Modality | Small molecule |
| Therapeutic area | Dermatology/Oncology |
| Phase | FDA-approved |
Mechanism of action
Ingenol mebutate is a diterpene ester that binds to and activates protein kinase C (PKC), leading to direct cytotoxic effects on keratinocytes and induction of local inflammation. This dual mechanism—direct cell death combined with immune activation—results in clearance of actinic keratosis lesions. The drug also appears to promote differentiation and apoptosis of abnormal skin cells.
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 exfoliation
- Headache
Key clinical trials
- PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy (PHASE1)
- Safety and Tolerability of Different Concentrations of an Ingenol Derivative Field Therapy in the Treatment of Actinic Keratosis (PHASE1)
- Histological Confirmation of Clinical Clearance of Actinic Keratoses Following Treatment With Ingenol Mebutate Gel, 0.05% (PHASE1)
- PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Histology (PHASE1)
- Safety and Dose Finding Study of New Vehicle Formulations Containing Ingenol Mebutate to Treat Actinic Keratosis on the Forearm (PHASE1, PHASE2)
- A Simultaneous Treatment Regimen Compared to a Sequential Treatment Regimen With Ingenol Mebutate Gel 0.015% and 0.05% of Two Areas With Actinic Keratosis on Face/Scalp and Trunk/Extremities (PHASE3)
- Study Evaluating the Efficacy and Safety of 0.05% Ingenol Mebutate (Picato® 500) in the Treatment of Basal Cell Carcinoma (PHASE2)
- Picato for the Treatment of Molluscum Contagiosum in Immunocompromised Patients (EARLY_PHASE1)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ingenol mebutate 0.05% gel CI brief — competitive landscape report
- ingenol mebutate 0.05% gel updates RSS · CI watch RSS
- Neal D. Bhatia, MD portfolio CI