Nemolizumab is under clinical development by Galderma and currently in Phase III for End-Stage Kidney Disease (End-Stage Renal Disease or ESRD). According to GlobalData, Phase III drugs for End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) have a 100% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Nemolizumab’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.

Nemolizumab overview

Nemolizumab (Mitchga) is monoclonal antibody against it is formulated as freeze dried powder for solution for subcutaneous route od administration. Mitchga is indicated for the treatment of itching associated with atopic dermatitis (AD) for adults and children 13 years and older.

Nemolizumab (CIM-331) is under development for the treatment of prurigo nodularis, atopic dermatitis, Chronic kidney disease associated severe pruritus, prurigo nodularis patients with moderate to severe pruritus and systemic sclerosis (scleroderma). The drug candidate is administered as a subcutaneous solution. It is an anti-IL-31 receptor alpha humanized monoclonal antibody. It is a new molecular entity (NME). It is developed based on proprietary antibody engineering technology ACT-Ig.

Galderma overview

Galderma develops and markets medical and consumer skin health products. The company provides prescription drugs and aesthetic solutions for the treatment of various skin conditions such as acne, rosacea, psoriasis and steroid-responsive dermatoses, nail mycosis, pigmentary disorders, skin cancer, atopic dermatitis, and sun protection among others. Its major brands include Epiduo, Differin, Oracea, Loceryl, Metvix, Azzalure/Dysport, Mirvaso, Soolantra, Restylane, Cetaphil, and Emervel. The company has its research and development centers and manufacturing sites in Asia-Pacific, the Middle East, Europe, Africa, and North and Latin America. Galderma is headquartered in Zug, Switzerland.

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

This content was updated on 10 June 2024

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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.