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Ingenol Mebutate (Picato®)
Ingenol Mebutate (Picato®) is a Protein kinase C (PKC) activator Small molecule drug developed by Actavis Inc.. It is currently in Phase 3 development for Actinic keratosis (field treatment on face or scalp). Also known as: Picato, RLD.
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).
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
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
Frequently asked questions about Ingenol Mebutate (Picato®)
What is Ingenol Mebutate (Picato®)?
How does Ingenol Mebutate (Picato®) work?
What is Ingenol Mebutate (Picato®) used for?
Who makes Ingenol Mebutate (Picato®)?
Is Ingenol Mebutate (Picato®) also known as anything else?
What drug class is Ingenol Mebutate (Picato®) in?
What development phase is Ingenol Mebutate (Picato®) in?
What are the side effects of Ingenol Mebutate (Picato®)?
What does Ingenol Mebutate (Picato®) target?
Related
- Drug class: All Protein kinase C (PKC) activator drugs
- Target: All drugs targeting Protein kinase C (PKC)
- Manufacturer: Actavis Inc. — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Actinic keratosis (field treatment on face or scalp)
- Also known as: Picato, RLD
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing