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no peer-reviewed controlled trials of intranasal DSIP in humans exist Human sleep studies produced weak, partially inconsistent effect sizes Pilot studies in pain and withdrawal were very small (6-7 patients) and lacked placebo controls No modern Phase I, II, or III clinical trials have been registered or published Long-Term Safety Considerations Critical safety questions remain entirely unanswered: Chronic effects of DSIP exposure have not been studied even in animal models beyond short experimental windows Interaction potential with medications, sleep aids, and anesthetic agents uncharacterized (one human study reported unexpected cardiovascular effects with isoflurane co-administration) Long-term neuroendocrine effects of ACTH suppression and LH stimulation unstudied Reproductive and developmental toxicity not investigated Regulatory & Competitive Sport Status FDA Position DSIP has not received FDA approval for any indication in humans or animals: Not approved for any therapeutic use in humans or animals Not recognized as GRAS (Generally Recognized as Safe) Not approved for compounding for human administration in the United States Classified as a research-use-only substance WADA Status DSIP does not currently appear on the World Anti-Doping Agency’s prohibited substance list by name

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It carries four substitutions, notably D-Ala at position 2, studied in vitro for increased resistance to dipeptidyl-peptidase-IV (DPP-IV) cleavage

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