Last reviewed · How we verify
PEP005 (ingenol mebutate) Gel
PEP005 (ingenol mebutate) Gel is a Protein kinase C (PKC) activator Small molecule drug developed by Peplin. It is currently in Phase 3 development for Actinic keratosis (field treatment on face or scalp).
Ingenol mebutate activates protein kinase C (PKC) to induce rapid necrosis of actinic keratosis cells and trigger immune-mediated clearance of remaining lesions.
Ingenol mebutate activates protein kinase C (PKC) to induce rapid necrosis of actinic keratosis cells and trigger immune-mediated clearance of remaining lesions. Used for Actinic keratosis (field treatment on face or scalp).
At a glance
| Generic name | PEP005 (ingenol mebutate) Gel |
|---|---|
| Sponsor | Peplin |
| Drug class | Protein kinase C (PKC) activator |
| Target | Protein kinase C (PKC) |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
The drug works through a dual mechanism: direct cytotoxic effects via PKC activation leading to cell death in treated lesions, and activation of local immune responses including neutrophil infiltration and antibody-dependent cellular cytotoxicity. This combination results in both immediate destruction of visible lesions and immunological elimination of subclinical disease in the surrounding skin.
Approved indications
- Actinic keratosis (field treatment on face or scalp)
Common side effects
- Local skin irritation (erythema, flaking, crusting)
- Application site pain or burning
- Pruritus
- Edema
- Vesiculation or pustulation
Key clinical trials
- Prospective Study of Ingenol Mebutate for Non-invasive Lentigo Melanoma of the Face (PHASE2)
- Safety and Efficacy of Ingenol Mebutate Once Daily for 2 or 3 Consecutive Days in Subjects With Actinic Keratosis (PHASE1, PHASE2)
- A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp (PHASE3)
- Efficacy and Safety of Ingenol Mebutate Gel 0.06% When Applied Once Daily for 2, 3 or 4 Consecutive Days to a Treatment Area of Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis (PHASE2)
- Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest (PHASE3)
- Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp (PHASE3)
- PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy (PHASE1)
- Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5% (PHASE4)
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:
- PEP005 (ingenol mebutate) Gel CI brief — competitive landscape report
- PEP005 (ingenol mebutate) Gel updates RSS · CI watch RSS
- Peplin portfolio CI
Frequently asked questions about PEP005 (ingenol mebutate) Gel
What is PEP005 (ingenol mebutate) Gel?
How does PEP005 (ingenol mebutate) Gel work?
What is PEP005 (ingenol mebutate) Gel used for?
Who makes PEP005 (ingenol mebutate) Gel?
What drug class is PEP005 (ingenol mebutate) Gel in?
What development phase is PEP005 (ingenol mebutate) Gel in?
What are the side effects of PEP005 (ingenol mebutate) Gel?
What does PEP005 (ingenol mebutate) Gel target?
Related
- Drug class: All Protein kinase C (PKC) activator drugs
- Target: All drugs targeting Protein kinase C (PKC)
- Manufacturer: Peplin — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Actinic keratosis (field treatment on face or scalp)
- Compare: PEP005 (ingenol mebutate) Gel vs similar drugs
- Pricing: PEP005 (ingenol mebutate) Gel cost, discount & access