Ingenol mebutate is under clinical development by Leo Pharma and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Ingenol mebutate’s likelihood of approval (LoA) and phase transition for Basal Cell Carcinoma (Basal Cell Epithelioma) took place on 20 Nov 2020, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Ingenol mebutate Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Ingenol mebutate overview

Ingenol mebutate (Picato, PEP005) is a compound derived from the sap of Euphorbia peplus, or E. peplus, a rapidly growing, readily available plant commonly referred to as petty spurge or radium weed. It is formulated as gel for topical application. Picato is indicated for the cutaneous treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis in adults. Ingenol induces a local lesion cell death and promotes an inflammatory response characterized by infiltration of immunocompetent cells.

PEP005 (ingenol mebutate) gel is under development for the treatment of molluscum contagiosum and basal cell carcinoma. It acts by targeting protein kinase C delta.

It was also under development for the treatment of squamous cell carcinoma, leukemias, bladder cancer, nonmelanomatous skin cancer and anogenital warts and common wart (verruca vulgaris).

Leo Pharma overview

Leo Pharma, a subsidiary of LEO Foundation, is a drug manufacturing company. It discovers, develops, manufactures, and commercializes medicines for skin diseases and thrombosis. Its product portfolio spans pharmaceuticals for the treatment of diseases such as eczema, psoriasis, skin infections, actinic keratosis, non-melanoma skin cancer and thrombosis. The company also manufactures and markets products for the treatment of bacterial infections, coagulation, cardiovascular, antibiotics, nutritional disorders, osteoporosis, and renal problems. Leo Pharma markets its products worldwide. The company has a presence in Europe, the Middle East, Africa, Asia, the Americas, and Oceania. Leo Pharma is headquartered in Ballerup, Denmark.

Quick View Ingenol mebutate LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Ingenol mebutate
Administration Pathway
  • Intravenous
  • Topical
Therapeutic Areas
  • Dermatology
  • Infectious Disease
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.