Birch triterpenes is under clinical development by Chiesi Farmaceutici and currently in Phase II for Radiodermatitis. According to GlobalData, Phase II drugs for Radiodermatitis does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Birch triterpenes LoA Report. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Birch triterpenes overview

Birch bark extract (Oleogel-S10, Filsuvez, Episalvan) from Betula pendula Roth/ Betula pubescens Ehrh is an herbal extract acts as dermatological agent. Oleogel-S10 contains a triterpene extract from birch bark as active ingredient. Triterpenes are terpenes consisting of six isoprene units. It is formulated as gel for topical and cutaneous application. It is indicated for the treatment of partial thickness wounds in adults. The drug cantains 72-88 percent betulin (a triterpene).

The drug candidate is under development for the treatment of stevens johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and radiation induced dermatitis. The drug candidate is administered topically. It was also under development for the treatment of actinic keratoses and epidermolysis bullosa (dystrophic epidermolysis bullosa/junctional epidermolysis bullosa).

Chiesi Farmaceutici overview

Chiesi Farmaceutici (Chiesi) researches, develops, produces and commercializes novel medicines with a focus on respiratory, neonatology, rare disease and special care therapeutic areas. The company provides products for the treatment of chronic obstructive pulmonary disease (COPD), asthma, rheumatoid arthritis, ankylosing spondylitis, hypertension, percutaneous coronary intervention, apnoea of prematurity, respiratory distress syndrome, lipoprotein lipase deficiency (LPLD), limbal stem cell deficiency (LSCD) and inflammatory bowel diseases, among others. The company operates production sites in Parma, Italy; Blois, France; and Santana De Parnaiba, Brazil; and conducts research and development activities in its R&D center in Parma and at laboratories in Paris (France), Chippenham (the UK), Cary (the US) and Lidingo (Sweden). Chiesi is headquartered in Parma, Emilia-Romagna, Italy.

For a complete picture of Birch triterpenes’s drug-specific PTSR and LoA scores, buy the report here.

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.