Ingenol mebutate

Generic Name
Ingenol mebutate
Brand Names
-
Drug Type
Small Molecule
Chemical Formula
C25H34O6
CAS Number
75567-37-2
Unique Ingredient Identifier
7686S50JAH
Background

Ingenol mebutate was approved by the FDA in January 2012, and it is marketed under the name Picato®. Picato gel is indicated for the topical treatment of actinic keratosis. Before approval, ingenol mebutate was called PEP005 as an investigational drug. PEP005 is a selective small molecule activator of protein kinase C (PKC) extracted from the plant Euphorbia peplus, whose sap has been used as a traditional medicine for the treatment of skin conditions including warts and cancer. PEP005 also has potent anti-leukemic effects, inducing apoptosis in myeloid leukemia cell lines and primary AML cells at nanomolar concentrations.

Indication

For the topical treatment of actinic keratosis.

Associated Conditions
Actinic Keratosis (AK)
Associated Therapies
-

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

Phase 2
Completed
Conditions
Interventions
First Posted Date
2013-12-03
Last Posted Date
2018-12-07
Lead Sponsor
LEO Pharma
Target Recruit Count
266
Registration Number
NCT01998984
Locations
🇺🇸

Long Island Skin Cancer and Dermatologic Surgery, Smithtown, New York, United States

Ingenol Mebutate Compared to Cryotherapy for the Treatment of Skin Lesions

Early Phase 1
Withdrawn
Conditions
Interventions
First Posted Date
2012-11-28
Last Posted Date
2021-12-06
Lead Sponsor
Northwestern University
Registration Number
NCT01735942

PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy

Phase 1
Completed
Conditions
Interventions
First Posted Date
2011-10-10
Last Posted Date
2016-05-09
Lead Sponsor
LEO Pharma
Target Recruit Count
24
Registration Number
NCT01449513
Locations
🇩🇪

Charité - Universitätsmedizin Berlin, Berlin, Germany

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