{
 "checked": "2026-10-24 (America/New_York)",
 "page": "https://jabbitapp.com/research/dsip-emideltide-delta-sleep-inducing-peptide-evidence-teardown.html",
 "fda": {
  "briefing_document": "https://www.fda.gov/media/193344/download",
  "briefing_note": "FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026; emideltide (free base) and emideltide acetate evaluated for the 503A bulks list for IV/SC use in chronic insomnia, narcolepsy and opioid withdrawal; nominations later withdrawn.",
  "briefing_quotes": [
   "the results appear inconclusive and at best preliminary",
   "whereas in the two DB PC studies by Bes et al. 1992 and Monti et al. 1987 who conducted similarly designed investigations did not reach the same conclusions",
   "administered intravenously to 209 subjects for 1 to 15 days",
   "Clinical studies were not identified that had information for emideltide (free base) or emideltide acetate for the proposed SC ROA",
   "The search retrieved zero reports",
   "Emideltide has a short plasma half-life of 8 minutes",
   "progressive hypotension",
   "used in compounding since at least 2018",
   "not registered drugs in any country searched via GlobalEdge",
   "No outsourcing facilities have reported compounding drug products containing emideltide",
   "marketing emideltide injection and nasal spray products",
   "These substances are not well characterized from a physical and chemical characterization perspective, and endotoxin testing for injectable ROA is lacking",
   "could have reinforcing properties that could, in turn, contribute to the development of addiction",
   "drugs that can inhibit dipeptidase (e.g., captopril)",
   "it may be unrelated to the presence of emideltide in Deltaran",
   "Accordingly, we propose not adding emideltide (free base) or emideltide acetate to the 503A Bulks L",
   "at best some weak effects",
   "of little clinical significance",
   "significantly reduced the heart rate of the rats by ~3%"
  ],
  "presentations": "https://www.fda.gov/media/193774/download",
  "event_page": "https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026",
  "event_page_status": "No minutes posted; content current as of 08/06/2026 when checked.",
  "category2_page": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
  "category2_status": "Emideltide (DSIP) is listed under 'Bulk drug substances nominated but withdrawn'. Page content current as of 04/22/2026.",
  "category2_text": "Compounded drugs containing emideltide may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and API characterization. FDA has not identified safety-related information regarding emideltide for the proposed route of administration. Therefore, the agency lacks sufficient information to know whether the drug would cause harm if administered to humans.",
  "oira": "RIN 0910-ZD94, Interim Access Policy for Compounding Using Certain Peptides, received 10/14/2026, Pending EO 12866 Regulatory Review; text not public. https://www.reginfo.gov/public/do/eoDetails?rrid=1568964",
  "faers_counts_by_medicinalproduct": {
   "DSIP": 0,
   "EMIDELTIDE": 0,
   "DELTA SLEEP INDUCING PEPTIDE": 0,
   "DELTA SLEEP-INDUCING PEPTIDE": 0,
   "DELTARAN": 13
  },
  "faers_note": "All 13 'DELTARAN' reports are from a German brand-name collision (reports for arthritis/pain, i.e. a diclofenac product), not the Russian DSIP preparation; excluded. DSIP/emideltide: zero, matching FDA's search through March 3, 2024.",
  "drugsfda_matches": {
   "EMIDELTIDE": 0,
   "DSIP": 0,
   "DELTA SLEEP": 0
  },
  "ndc_directory": {
   "listings": 4,
   "product_type": "BULK INGREDIENT",
   "active_ingredient_as_coded": "EMIDELTIDE",
   "marketing_start_dates": [
    "20200205",
    "20260330",
    "20260501",
    "20260804"
   ],
   "note": "Bulk-ingredient (API powder) registrations, not FDA approvals. Labelers not named here."
  },
  "enforcement": {
   "recall_number": "D-0138-2021",
   "classification": "Class II",
   "recall_initiation_date": "20201130",
   "reason_for_recall": "Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.",
   "voluntary_mandated": "Voluntary: Firm initiated",
   "note": "One FDA enforcement record (2020) for a compounded DSIP vial among products recalled for lack of sterility assurance. Firm not named here."
  }
 },
 "vote": {
  "result": "6 yes, 7 no, 1 abstain on both emideltide forms (as transcribed; no official minutes)",
  "peptidebase": "https://peptidebase.io/fda/pcac-july-2026/emideltide",
  "mdside": "https://www.mdside.com/peptide-advisory-vote-what-happens-next/",
  "cspi_letter": "https://www.cspi.org/sites/default/files/2026-10/CSPI%20Letter%20to%20FDA%20re%20PCAC.pdf",
  "by_group": {
   "new:-": 1,
   "new:N": 1,
   "new:Y": 6,
   "other:-": 4,
   "other:A": 1,
   "other:N": 6
  },
  "group_note": "'new' = the eight members seated in 2026 per the PeptideBase/CSPI rosters. Individual votes are not reproduced on the page."
 },
 "registry": {
  "api": "ClinicalTrials.gov API v2, query.term, all pages, 2026-10-24",
  "counts": {
   "\"delta sleep-inducing peptide\"": 0,
   "\"delta sleep inducing peptide\"": 0,
   "DSIP": 0,
   "emideltide": 0,
   "Deltaran": 0
  }
 },
 "pubmed": {
  "all": "540",
  "1970-1979": "12",
  "1980-1989": "220",
  "1990-1999": "182",
  "2000-2009": "81",
  "2010-2019": "35",
  "2020-2026": "10",
  "human_trials": "20",
  "rct": "7",
  "since2016_human_trials": "1"
 },
 "pubmed_note": "The 20 'human trial' hits include unrelated records (spine, adrenal) matched by the DSIP acronym; the DSIP trials are small 1981-2009 IV studies. One hit since 2016, and it is unrelated.",
 "human_sleep_studies": [
  {
   "pmid": "6895513",
   "year": 1981,
   "group": "Discovering group",
   "design": "Healthy volunteers, double-blind crossover",
   "n": 6,
   "result": "Positive (authors)"
  },
  {
   "pmid": "7028502",
   "year": 1981,
   "group": "Discovering group",
   "design": "Insomnia, single doses",
   "n": 6,
   "result": "Positive (authors)"
  },
  {
   "pmid": "6391926",
   "year": 1984,
   "group": "Other clinic",
   "design": "Insomnia, open-label, no control",
   "n": 7,
   "result": "Positive (author), uncontrolled"
  },
  {
   "pmid": "3792404",
   "year": 1986,
   "group": "Discovering group",
   "design": "Insomnia, no placebo group",
   "n": 18,
   "result": "Positive (authors)"
  },
  {
   "pmid": "3622582",
   "year": 1987,
   "group": "Discovering group",
   "design": "Insomnia, placebo nights only (FDA puts 'placebo-controlled' in quotes)",
   "n": 14,
   "result": "Positive (authors)"
  },
  {
   "pmid": "3583493",
   "year": 1987,
   "group": "Independent",
   "design": "Insomnia, randomized double-blind placebo crossover",
   "n": 6,
   "result": "Little clinical significance"
  },
  {
   "pmid": "1299794",
   "year": 1992,
   "group": "Independent",
   "design": "Insomnia, double-blind placebo parallel groups",
   "n": 16,
   "result": "Weak; not likely of major benefit"
  }
 ],
 "key_pmids": {
  "12782416": {
   "title": "Effect of delta-sleep inducing peptide-containing preparation Deltaran on biomarkers of aging, life span and spontaneous tumor incidence in female SHR mice.",
   "journal": "Mech Ageing Dev",
   "year": "2003"
  },
  "1299794": {
   "title": "Effects of delta sleep-inducing peptide on sleep of chronic insomniac patients. A double-blind study.",
   "journal": "Neuropsychobiology",
   "year": "1992"
  },
  "16539679": {
   "title": "Delta sleep-inducing peptide (DSIP): a still unresolved riddle.",
   "journal": "J Neurochem",
   "year": "2006"
  },
  "19142086": {
   "title": "Delta sleep-inducing peptide alters bispectral index, the electroencephalogram and heart rate variability when used as an adjunct to isoflurane anaesthesia.",
   "journal": "Eur J Anaesthesiol",
   "year": "2009"
  },
  "265572": {
   "title": "Characterization of a delta-electroencephalogram (-sleep)-inducing peptide.",
   "journal": "Proc Natl Acad Sci U S A",
   "year": "1977"
  },
  "3583493": {
   "title": "Study of delta sleep-inducing peptide efficacy in improving sleep on short-term administration to chronic insomniacs.",
   "journal": "Int J Clin Pharmacol Res",
   "year": "1987"
  },
  "3622582": {
   "title": "Effects of delta-sleep-inducing peptide on 24-hour sleep-wake behaviour in severe chronic insomnia.",
   "journal": "Eur Neurol",
   "year": "1987"
  },
  "6548968": {
   "title": "Effects of DSIP on narcolepsy.",
   "journal": "Eur Neurol",
   "year": "1984"
  },
  "6548969": {
   "title": "DSIP in the treatment of withdrawal syndromes from alcohol and opiates.",
   "journal": "Eur Neurol",
   "year": "1984"
  },
  "7405185": {
   "title": "Effect of delta sleep inducing peptide (DSIP) and arginine vasotocin (AVT) on sleep and motor activity in the rat.",
   "journal": "Waking Sleeping",
   "year": "1980"
  },
  "8475226": {
   "title": "Delta sleep-inducing peptide administration does not influence growth hormone and prolactin secretion in normal women.",
   "journal": "Psychoneuroendocrinology",
   "year": "1993"
  },
  "8532601": {
   "title": "Delta sleep-inducing peptide in normal humans and in patients with sleep apnea and narcolepsy.",
   "journal": "Peptides",
   "year": "1995"
  }
 },
 "analysis": {
  "registered_trials": 0,
  "faers_reports_dsip": 0,
  "approved_anywhere_globaledge": false,
  "human_iv_participants_per_fda": 209,
  "sc_or_nasal_human_safety_studies": 0,
  "positive_reports_discovering_group": 4,
  "uncontrolled_open_label_positive": 1,
  "independent_placebo_controlled_insomnia_studies": 2,
  "independent_positive": 0,
  "note": "Jabbit tally. Four of the five positive human sleep reports come from the Basel research group that discovered DSIP (the fifth is an uncontrolled open-label series); the two independent placebo-controlled insomnia studies found little or no benefit. All human dosing was IV; sold products are SC injection or nasal spray."
 }
}