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Picato (INGENOL MEBUTATE)
Ingenol mebutate (Picato), marketed by Leo Labs, is a topical treatment for actinic keratosis with a well-established presence in the dermatology segment. A key strength of Picato is its unique mechanism of action, which differentiates it from other treatments in the market. The primary risk to consider is the key composition patent expiry in 2028, which could lead to increased competition from generic alternatives.
At a glance
| Generic name | INGENOL MEBUTATE |
|---|---|
| Sponsor | Leo Labs |
| Target | Protein kinase C alpha type, Protein kinase C epsilon type, Protein kinase C gamma type |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 2012 |
Approved indications
- Actinic keratosis
Common side effects
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)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Picato CI brief — competitive landscape report
- Picato updates RSS · CI watch RSS