Aminolevulinic acid hydrochloride is under clinical development by Biofrontera and currently in Phase II for Cutaneous Squamous Cell Carcinoma (cSCC). According to GlobalData, Phase II drugs for Cutaneous Squamous Cell Carcinoma (cSCC) have a 42% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Aminolevulinic acid hydrochloride’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. 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.
Aminolevulinic acid hydrochloride overview
Aminolevulinic acid hydrochloride (Ameluz) is a dermatological agent. It is formulated as a gel for topical and cutaneous application. Ameluz in combination with daylight Photodynamic Therapy (daylight PDT) is indicated for the treatment of minimally to moderately thick actinic keratoses of the face or scalp, for the treatment of field cancerization and for the treatment of superficial and/or nodular basal cell carcinoma unsuitable for surgical treatment due to possible treatment-related morbidity and/or poor cosmetic outcome in adults.
Aminolevulinic acid hydrochloride is under development for the treatment of actinic keratoses on face and scalp, extremities of neck and trunk, acne vulgaris, basal cell carcinoma and squamous cell carcinoma and facial cutaneous squamous cell carcinoma in situ (SCCis).
The drug candidate was also under development for the treatment of condyloma.
Biofrontera overview
Biofrontera is a biopharmaceutical company that specializes in the research, development, and distribution of dermatological products. Biofrontera‘s major products include Ameluz, a topical prescription drug, and BF-RhodoLED, and RhodoLED XL, proprietary red-light lamps used for photodynamic therapy of certain superficial skin cancers and its precursors. The company also markets the dermocosmetics series Belixos, which offers treatment for damaged or diseased skin. The company distributes its products through its own sales organizations in Germany, Spain, and the UK, and through independent license partners in other European countries, the US, and Asian and Oceanic markets. Biofrontera is headquartered in Leverkusen, North Rhine-Westphalia, Germany.
For a complete picture of Aminolevulinic acid hydrochloride’s drug-specific PTSR and LoA scores, buy the report here.
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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 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.
