Last reviewed · How we verify
Ingenol mebutate gel 0.05 %
Ingenol mebutate gel 0.05 % is a Protein kinase C activator Small molecule drug developed by LEO Pharma. It is currently in Phase 3 development for Actinic keratosis (field treatment). Also known as: Picato®.
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).
At a glance
| Generic name | Ingenol mebutate gel 0.05 % |
|---|---|
| Also known as | Picato® |
| Sponsor | LEO Pharma |
| Drug class | Protein kinase C activator |
| Target | Protein kinase C (PKC) |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
Ingenol mebutate is a diterpene ester that binds to and activates protein kinase C (PKC), leading to direct cytotoxic effects on actinic keratosis cells through necrosis. Additionally, it triggers an inflammatory response that recruits immune cells to the treated area, facilitating clearance of abnormal keratinocytes and promoting skin healing.
Approved indications
- Actinic keratosis (field treatment)
Common side effects
- Application site erythema
- Application site pain
- Application site pruritus
- Application site edema
- Application site erosion
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 gel 0.05 % CI brief — competitive landscape report
- Ingenol mebutate gel 0.05 % updates RSS · CI watch RSS
- LEO Pharma portfolio CI
Frequently asked questions about Ingenol mebutate gel 0.05 %
What is Ingenol mebutate gel 0.05 %?
How does Ingenol mebutate gel 0.05 % work?
What is Ingenol mebutate gel 0.05 % used for?
Who makes Ingenol mebutate gel 0.05 %?
Is Ingenol mebutate gel 0.05 % also known as anything else?
What drug class is Ingenol mebutate gel 0.05 % in?
What development phase is Ingenol mebutate gel 0.05 % in?
What are the side effects of Ingenol mebutate gel 0.05 %?
What does Ingenol mebutate gel 0.05 % target?
Related
- Drug class: All Protein kinase C activator drugs
- Target: All drugs targeting Protein kinase C (PKC)
- Manufacturer: LEO Pharma — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Actinic keratosis (field treatment)
- Also known as: Picato®
- Compare: Ingenol mebutate gel 0.05 % vs similar drugs
- Pricing: Ingenol mebutate gel 0.05 % cost, discount & access