Ingenol mebutate

Overview

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)

Clinical Trials

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Title	Posted	Study ID	Phase	Status	Sponsor
Assessment of Treatment Success and Quality of Life in Patients With Actinic Keratoses Under Therapy With Ingenol Mebutate in a Period of 8 Weeks	2014/03/18	NCT02090465	N/A	Completed	LEO Pharma
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	2013/12/03	NCT01998984	Phase 2	Completed	LEO Pharma
Safety and Efficacy of Ingenol Mebutate Once Daily for 2 or 3 Consecutive Days in Subjects With Actinic Keratosis	2013/03/28	NCT01820260	Phase 1	Completed	LEO Pharma
Ingenol Mebutate Compared to Cryotherapy for the Treatment of Skin Lesions	2012/11/28	NCT01735942	Early Phase 1	Withdrawn	Northwestern University
PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy	2011/10/10	NCT01449513	Phase 1	Completed	LEO Pharma
The Purpose of This Study is to Determine Whether Topical Application of PEP005 is Safe for the Treatment of Common Wart(s)	2007/10/19	NCT00546611	Phase 1	Withdrawn	Peplin
Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005	2007/10/16	NCT00544258	Phase 1	Completed	Peplin
To Determine the Maximum Tolerated Dose Level (MTD) of PEP005 Topical Gel in Patients With sBCC	2007/02/07	NCT00432185	Phase 2	Completed	Peplin
A Study to Determine the Optimal Tolerated Regime and Safety of PEP005 Topical Gel	2007/01/26	NCT00427050	Phase 2	Completed	Peplin
Study to Determine the Safety of PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses	2006/09/13	NCT00375739	Phase 2	Completed	Peplin

FDA Drug Approvals

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Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

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Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
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NMPA Drug Approvals

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Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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TGA Drug Approvals

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