Last reviewed · How we verify
Ingenol Mebutate (Picato®)
Ingenol mebutate is a protein kinase C (PKC) activator that induces rapid necrosis of actinic keratosis cells and promotes immune-mediated clearance of treated lesions.
Ingenol mebutate is a protein kinase C (PKC) activator that induces rapid necrosis of actinic keratosis cells and promotes immune-mediated clearance of treated lesions. Used for Actinic keratosis (field treatment on face or scalp).
At a glance
| Generic name | Ingenol Mebutate (Picato®) |
|---|---|
| Also known as | Picato, RLD |
| Sponsor | Actavis Inc. |
| 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 actinic keratosis cells through mitochondrial dysfunction and rapid cell death. Additionally, it triggers an inflammatory response that recruits immune cells to the treatment area, resulting in clearance of residual diseased cells and promotion of normal skin regeneration.
Approved indications
- Actinic keratosis (field treatment on face or scalp)
Common side effects
- Application site erythema
- Application site pain
- Application site edema
- Application site pruritus
- Application site erosion
Key clinical trials
- Prospective Study of Ingenol Mebutate for Non-invasive Lentigo Melanoma of the Face (PHASE2)
- A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp (PHASE3)
- Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5% (PHASE4)
- 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)
- Safety and Efficacy of Repeat Use of Picato® 0.05% in the Treatment of Anogenital Warts (PHASE2)
- Efficacy and Safety of Ingenol Mebutate Gel 0.015% Compared to Diclofenac Sodium Gel 3% in Subjects With Actinic Keratoses on the Face or Scalp (PHASE4)
- Study Evaluating the Efficacy and Safety of 0.05% Ingenol Mebutate (Picato® 500) in the Treatment of Basal Cell Carcinoma (PHASE2)
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 (Picato®) CI brief — competitive landscape report
- Ingenol Mebutate (Picato®) updates RSS · CI watch RSS
- Actavis Inc. portfolio CI