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Ingenol metabute
Ingenol metabute is a Protein kinase C (PKC) activator Small molecule drug developed by LEO Pharma. It is currently in Phase 3 development for Actinic keratosis (field treatment on face or scalp). Also known as: Picato® gel, 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 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 metabute |
|---|---|
| Also known as | Picato® gel, 0.015% |
| Sponsor | LEO Pharma |
| 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 keratinocytes and induction of local inflammatory responses. This dual mechanism—direct cell death combined with immune activation—results in clearance of actinic keratosis lesions. The drug is applied topically and works through both intrinsic apoptotic pathways and PKC-dependent signaling.
Approved indications
- Actinic keratosis (field treatment on face or scalp)
Common side effects
- Application site erythema
- Application site pain
- Application site pruritus
- Application site edema
Key clinical trials
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 metabute CI brief — competitive landscape report
- Ingenol metabute updates RSS · CI watch RSS
- LEO Pharma portfolio CI
Frequently asked questions about Ingenol metabute
What is Ingenol metabute?
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What does Ingenol metabute target?
Related
- Drug class: All Protein kinase C (PKC) 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 on face or scalp)
- Also known as: Picato® gel, 0.015%
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing