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ingenol mebutate 0.015%
Ingenol mebutate is a protein kinase C (PKC) activator that induces rapid necrosis of actinic keratosis cells and promotes immune-mediated clearance of damaged skin.
Ingenol mebutate is a protein kinase C (PKC) activator that induces rapid necrosis of actinic keratosis cells and promotes immune-mediated clearance of damaged skin. Used for Actinic keratosis (field treatment on face or scalp).
At a glance
| Generic name | ingenol mebutate 0.015% |
|---|---|
| Also known as | ingenol mebutate 0.015% qdaily x 3 days for two cycles, Picato® gel, Picato |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Drug class | Protein kinase C (PKC) activator |
| Target | Protein kinase C (PKC) |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | FDA-approved |
Mechanism of action
Ingenol mebutate activates protein kinase C, leading to direct cytotoxic effects on keratinocytes and induction of an inflammatory response that recruits immune cells to eliminate dysplastic cells. The drug causes rapid cell death in actinic keratosis lesions while simultaneously triggering local immune activation, resulting in clearance of both treated and untreated lesions in the surrounding area.
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
- Crusting/scabbing
Key clinical trials
- A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp (PHASE3)
- Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp (PHASE3)
- Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5% (PHASE4)
- 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)
- 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)
- Picato for the Treatment of Molluscum Contagiosum in Immunocompromised Patients (EARLY_PHASE1)
- Safety and Efficacy of Ingenol Mebutate Gel 0.015% for Treatment of AK on the Face in Solid Organ Transplant Recipients (PHASE4)
- 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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ingenol mebutate 0.015% CI brief — competitive landscape report
- ingenol mebutate 0.015% updates RSS · CI watch RSS
- Icahn School of Medicine at Mount Sinai portfolio CI