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Why DSIP Was in Category 2 The FDA placed Emideltide (DSIP) in Category 2 of the 503A bulk drug substances list — the category reserved for substances that "raise significant safety concerns." While specific details of the FDA's rationale are not always publicly elaborated, Category 2 placement typically reflects concerns about one or more of the following: Limited human safety data in US regulatory standards Concerns about compounding quality control for peptide formulations Potential for misuse or off-label application without adequate medical supervision Insufficient characterization of dose-response relationships The practical effect of Category 2 placement was that compounding pharmacies could not legally prepare DSIP formulations for patients, effectively cutting off access for the patients who relied on it most
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The published human trials from the 1980s used 25 nmol/kg intravenously for short courses, typically four to seven nights, in chronic-insomniac volunteers