Ingenol mebutate
- Generic Name
- Ingenol mebutate
- 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)
Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Cutaneous Squamous Cell Carcinoma In Situ
- Conditions
- Carcinoma, Squamous Cell
- First Posted Date
- 2006-05-24
- Last Posted Date
- 2015-01-19
- Lead Sponsor
- Peplin
- Target Recruit Count
- 24
- Registration Number
- NCT00329121
- Locations
- 🇦🇺
The Skin Centre, Benowa, Queensland, Australia
🇦🇺Siller Medical, Brisbane, Queensland, Australia
🇦🇺Southderm Pty Ltd, Kogarah, New South Wales, Australia
Study to Determine the Maximum Tolerated Dose and Safety of PEP005 Topical Gel
- Conditions
- Keratosis
- First Posted Date
- 2005-10-14
- Last Posted Date
- 2015-03-25
- Lead Sponsor
- Peplin
- Target Recruit Count
- 34
- Registration Number
- NCT00239135
- Locations
- 🇺🇸
Dermatology Associates of Tyler, Tyler, Texas, United States
Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Superficial Basal Cell Carcinoma
- Conditions
- Basal Cell Carcinoma
- First Posted Date
- 2005-04-15
- Last Posted Date
- 2008-12-24
- Lead Sponsor
- Peplin
- Target Recruit Count
- 60
- Registration Number
- NCT00108134
- Locations
- 🇦🇺
Southderm Pty Ltd, Sydney, New South Wales, Australia
🇦🇺St George Dermatology & Skin Cancer Centre, Sydney, New South Wales, Australia
🇦🇺Skin and Cancer Foundation, Melbourne, Victoria, Australia
Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Nodular Basal Cell Carcinoma
- Conditions
- Basal Cell Carcinoma
- First Posted Date
- 2005-04-15
- Last Posted Date
- 2015-01-19
- Lead Sponsor
- Peplin
- Target Recruit Count
- 60
- Registration Number
- NCT00108121
- Locations
- 🇦🇺
Skin and Cancer Foundation, Melbourne, Victoria, Australia
🇦🇺Southderm Pty Ltd, Sydney, New South Wales, Australia
🇦🇺St George Dermatology & Skin Cancer Centre, Sydney, New South Wales, Australia
Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Actinic Keratoses
- First Posted Date
- 2005-04-12
- Last Posted Date
- 2015-03-25
- Lead Sponsor
- Peplin
- Target Recruit Count
- 60
- Registration Number
- NCT00107965
- Locations
- 🇦🇺
Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
🇦🇺Siller Medical, Brisbane, Queensland, Australia
🇦🇺Private Dermaology Clinic, Fremantle, Western Australia, Australia
Drug Development Updates
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