Mitochondrial & sleep · Research nonapeptide
Also known as delta sleep-inducing peptide, delta-sleep-inducing peptide, DSIP
The defined nine-amino-acid peptide historically called delta sleep-inducing peptide or DSIP. It is not FDA approved.[1][4]
Some human evidence exists, but it is small, early, indirect, or limited to a particular formulation or population.
Reviewed Jul 22, 2026 · U.S.-focused reference profile
Read the context, not only the compound name. Evidence and status can change with the form, route, population, and use. This profile does not assess individual suitability.
Orientation
Start with identity and research context. Similar names do not establish equivalent products or evidence.
Published research or product contexts. These are not personal indications.
Evidence can change with chemical form, formulation, route, ingredients, and manufacturing. A brand, salt, fragment, or cosmetic ingredient may not represent the same evidence.
What is known
Some human evidence exists, but it is small, early, indirect, or limited to a particular formulation or population. This is a description, not a rating or recommendation.
Energy, sleep and healthy-aging research
Old, small intravenous studies in healthy volunteers produced mixed neuroendocrine and sleep-related findings. FDA judged the clinical evidence preliminary or inconclusive and methodologically inadequate for an insomnia conclusion.
The historical literature uses small samples and varying outcomes, and marketed names may not establish free-base versus acetate identity. Effectiveness, modern safety characterization, pharmacokinetics, and long-term outcomes remain unresolved.
Source [1]The peptide was isolated and characterized through animal sleep research, followed by varied animal and laboratory experiments. Those findings do not establish a human sleep benefit.[4]
More human evidence does not automatically transfer to a different product, route, population, or purpose. Limited evidence does not prove no biological activity; it means the relevant clinical question is not established by the reviewed material.
What needs caution
Known published concerns and unanswered questions are kept separate so absence of evidence is never presented as reassurance.
Human safety data are small and incomplete. FDA summarized transient headache, nausea, vertigo, and hypotension in limited reports and identified unresolved impurity, aggregation, immunogenicity, and formulation concerns.
Research or cosmetic products may add identity, strength, purity, sterility, contamination, or formulation concerns. This is separate from the evidence about the compound itself.Source [1]The historical literature uses small samples and varying outcomes, and marketed names may not establish free-base versus acetate identity. Effectiveness, modern safety characterization, pharmacokinetics, and long-term outcomes remain unresolved.
Human outcomes, long-term safety, formulation identity, and product consistency remain limited or unresolved in the cited material.Source [1]Common effects, important warnings, product-quality concerns, and evidence gaps are different kinds of information. A risk in one product label may not apply to every formulation; an uncertainty proves neither safety nor harm.
Match the product
Form describes the specific product; route describes how it reaches the body. These are sourced descriptions, not instructions.
This entry covers the defined DSIP nonapeptide while distinguishing free base and acetate. No FDA-approved formulation exists.
Intravenous administration describes limited historical human studies only. It is not an approved route or an instruction for use.
U.S. product context
No FDA-approved medicine was identified for this defined material. Research findings and products sold outside reviewed trials should not be treated as approval.
Status applies to a product, formulation, route, population, and use. It does not apply to a name in the abstract.
Emideltide (DSIP) is not FDA approved. In a May 2026 staff briefing prepared for the July 23-24 advisory-committee meeting, FDA said the evaluation criteria weighed against 503A Bulks List inclusion; FDA stated that no final determination would be issued until the advisory process and reviews were complete.
Specific form or route not separately published in this record.View sourceTake it forward
Organize a conversation with a qualified professional without creating a treatment recommendation, dose, or protocol.
Trace the record
Each source supports the section that cites it; publication does not imply endorsement or suitability.
FDA staff briefing for emideltide-related substances
U.S. Food and Drug Administration. FDA Evaluation of Emideltide-Related Bulk Drug Substances (Emideltide (Free Base) and Emideltide Acetate). Pharmacy Compounding Advisory Committee briefing document. 2026.
U.S. Food and Drug Administration · Published May 11, 2026 · Accessed Jul 22, 2026 · Regulatory source
Open sourceDSIP and ACTH secretion in healthy volunteers
Bjartell A, et al. Delta sleep-inducing peptide and pituitary-adrenocortical secretion in healthy humans. Psychoneuroendocrinology. 1989;14(6):471-478.
PubMed-indexed primary study · Published Jan 1, 1989 · Accessed Jul 22, 2026 · Clinical study
Open sourceHuman study finding no ACTH or cortisol effect from DSIP
Spath-Schwalbe E, et al. No effect of delta-sleep-inducing peptide on nocturnal sleep and endocrine secretion in humans. Psychoneuroendocrinology. 1995;20(5):475-484.
PubMed-indexed primary study · Published Jan 1, 1995 · Accessed Jul 22, 2026 · Clinical study
Open sourceOriginal sequence report for delta sleep-inducing peptide
Schoenenberger GA, et al. A naturally occurring delta-EEG enhancing nonapeptide in rabbits. Pflugers Archiv. 1978;376(2):119-129.
PubMed-indexed primary study · Published Sep 1, 1978 · Accessed Jul 22, 2026 · Preclinical study
Open sourceIdentity, human evidence, laboratory and animal findings, risks, uncertainty, and U.S. product status are shown separately. Missing information stays marked as unpublished instead of being inferred.
