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NovoGluten
- Development stage
- Preclinical
- Lead developer
- Novoviah Pharmaceuticals
- Modality
- Recombinant Proteins and Enzymes
- Administration
- Oral
01
Overview
NovoGluten is a standardized clinical gluten product developed by Novoviah Pharmaceuticals for use in celiac disease clinical trials and gluten challenge studies. It is designed to provide consistent and credible gluten material to elicit and measure immune responses in patients with celiac disease. The product undergoes extensive testing for protein content, water, R5-ELISA, and microbiology, and is evaluated in stability studies under various storage conditions. It serves as a standardized challenge or diagnostic material rather than a therapeutic agent, helping researchers inform study design, statistical powering, and analysis for celiac disease research. The active ingredient consists of gluten protein derived from wheat, barley, and/or rye.
- Brand names
- NovoGluten
- Other names
- clinical gluten productgluten challenge material
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