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Manufacturing was soon halted in 2002 due to a combination of factors, including an efficacy below 80%, achieved only after multiple doses, limited strain coverage, and no availability for children, a critical population not included in safety and efficacy testing

However, in the 25 to 33% of patients who experience shunting with thiopurine monotherapy (preferential metabolism to less effective and potentially toxic thiopurine metabolites), low doses of thiopurines in combination with allopurinol may be prescribed to improve therapeutic effect

Any therapeutic use occurs under physician supervision as off-label research application requiring comprehensive informed consent, medical monitoring, and understanding that the peptide is not an approved pharmaceutical agent

Jun 2020;9(6):2714-2719