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Ingenol Mebutate Gel, 0.015%
Ingenol Mebutate Gel, 0.01% is a marketed topical treatment developed by LEO Pharma for primary indications in dermatology. The drug's key strength lies in its unique mechanism of action, which differentiates it from other topical treatments. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | Ingenol Mebutate Gel, 0.015% |
|---|---|
| Also known as | Picato® |
| Sponsor | LEO Pharma |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Common side effects
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 Gel, 0.015% CI brief — competitive landscape report
- Ingenol Mebutate Gel, 0.015% updates RSS · CI watch RSS
- LEO Pharma portfolio CI