DSIP vs Epithalon
DSIP (delta sleep-inducing peptide, non-proprietary name emideltide) and Epithalon (epitalon) are both short peptides linked to sleep and the pineal or circadian system, and the FDA reviewed both at the same Pharmacy Compounding Advisory Committee session on 24 July 2026 3. DSIP is a nine-amino-acid peptide first isolated from rabbit cerebral venous blood, with small human insomnia studies from the 1980s and 1990s 1,5. Epithalon is a synthetic four-amino-acid peptide based on the amino-acid content of a bovine pineal extract, and the FDA found no clinical data to support its safety in humans 2. In its briefing documents the FDA proposed that neither be included on the 503A bulks list for compounding 1,2.
Side by side
| Field | DSIP | Epithalon |
|---|---|---|
| Class | Nonapeptide (Trp-Ala-Gly-Gly-Asp-Ala-Ser-Gly-Glu) 1 | Synthetic tetrapeptide (Ala-Glu-Asp-Gly) 2 |
| Origin and structure | Isolated from rabbit cerebral venous blood in 1977; no gene, precursor protein or receptor has been identified 5 | Synthesised from the amino-acid composition of epithalamin, a bovine pineal gland extract; the FDA treats epitalon and epithalamin as different substances 2,9 |
| Proposed mechanism | Proposed sleep-promoting factor, but a review describes the link to sleep as poorly documented and the natural role as unresolved 5 | In human fetal fibroblast cultures, induced telomerase activity and telomere elongation 8; reported to raise melatonin levels, by an unknown mechanism 2 |
| Half-life | About 3–6 minutes in dogs and 2–3 minutes in rats and a monkey after intravenous dosing; 5–10 minutes in human serum in vitro 1 | No pharmacokinetic data found by the FDA 2 |
| Highest human trial phase | Small double-blind placebo-controlled studies in chronic insomnia, not phase-labelled 6,7; no registered trials found 11 | No completed trials identified; one early phase 1 multi-agent ageing study (NCT07888595) matched a registry search 12 |
| FDA status | Not FDA-approved; no Drugs@FDA record 13; FDA proposed it not be included on the 503A bulks list (PCAC, 24 July 2026) 1,3; previously listed among withdrawn category 2 compounding nominations 4 | Not FDA-approved 2; FDA proposed it not be included on the 503A bulks list (PCAC, 24 July 2026) 2,3; previously listed among withdrawn category 2 compounding nominations 4 |
| Published human outcomes | Insomnia studies of 14 and 16 patients gave mixed results; the FDA judged the evidence inconclusive and preliminary 1,6,7 | The FDA found no studies in insomnia; available human reports concern melatonin levels in older people, mostly with the related extract epithalamin 2 |
| Safety signals | Intravenous studies in withdrawal reported transient headache, nausea and vertigo, and cases of hypotension; no safety data for subcutaneous use 1 | FDA found no human safety data and flagged a theoretical cancer concern because it activates telomerase 2 |
| WADA status | Not named on the 2026 Prohibited List 10 | Not named on the 2026 Prohibited List; S0 covers substances with no governmental approval for human use 10 |
| Who funded the evidence | Academic groups, including the Basel group that isolated it and Dutch and Russian researchers; funding statements not located 5,7 | Largely the St Petersburg group of Vladimir Khavinson and the Russian Academy of Medical Sciences 2,8 |
DSIP: what the data says
DSIP was isolated from rabbit cerebral venous blood in 1977 and proposed as a sleep factor, but a 2006 review notes that no gene, precursor protein or receptor has been identified and that the sleep hypothesis remains weakly documented 5. In animals (dogs, rats and a monkey), its half-life after intravenous dosing was a few minutes, and it is broken down quickly by blood peptidases 1.
Human data are small and mixed. A double-blind placebo-controlled study in 14 people with severe chronic insomnia reported improved night sleep and daytime alertness 6. A double-blind study in 16 people with chronic insomnia found only weak effects that may have reflected changes in the placebo group, and the authors judged a major therapeutic effect unlikely 7. In its 2026 review, the FDA concluded that the insomnia evidence was inconclusive and that there were no safety data for the subcutaneous route 1.
Epithalon: what the data says
Epithalon was synthesised from the amino-acid composition of epithalamin, a bovine pineal extract, and much of the literature comes from the group that developed it 2,9. In human fetal fibroblast cultures (cell data), it induced telomerase expression and activity and lengthened telomeres 8. A 2025 review summarises cell, animal and computational work reporting effects on melatonin synthesis, enzyme activity and immune-cell markers, while noting that its mechanisms remain uncertain 9.
The FDA's 2026 review found no studies of epitalon in people with insomnia, no pharmacokinetic data and no human safety data 2. It also noted that available mouse toxicology studies were too limited to inform cancer risk, which it considered relevant because epitalon activates telomerase 2.
Key research differences
- Size and origin: DSIP is a nine-amino-acid peptide first isolated from rabbit blood 1,5, whereas Epithalon is a synthetic four-amino-acid peptide modelled on a bovine pineal extract 2.
- Human data: DSIP has small placebo-controlled insomnia studies with mixed results 6,7; the FDA found no insomnia studies of Epithalon 2.
- Pharmacokinetics: DSIP half-life values of a few minutes have been measured in animals and human serum 1, while the FDA found no pharmacokinetic data for Epithalon 2.
- Safety concerns: the FDA noted transient headache, nausea, vertigo and hypotension in DSIP withdrawal studies 1, and a theoretical cancer concern from telomerase activation for Epithalon 2.
Where the evidence is limited
No study has compared DSIP and Epithalon. The DSIP human studies are decades old, small and inconsistent 6,7, and the FDA judged them inconclusive 1. Epithalon evidence is mostly cell and animal work from a single research network, and human reports often concern the related extract epithalamin rather than Epithalon itself 2,9. Neither has pharmacokinetic or safety data for subcutaneous use in people 1,2.
Frequently asked questions
Are DSIP and Epithalon the same thing?
Has DSIP been tested for insomnia in humans?
Can DSIP and Epithalon be compared directly?
References
- FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: Emideltide-Related Bulk Drug Substances (Emideltide (free base) and Emideltide acetate) FDA. 2026
- FDA Briefing Document, Pharmacy Compounding Advisory Committee, July 23-24, 2026: Epitalon-Related Bulk Drug Substances (Epitalon (free base) and Epitalon acetate) FDA. 2026
- July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee (content current as of 08/06/2026) FDA. 2026
- Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (content current as of 04/22/2026) FDA (Human Drug Compounding). 2026
- Delta sleep-inducing peptide (DSIP): a still unresolved riddle Journal of Neurochemistry. 2006
- Effects of delta-sleep-inducing peptide on 24-hour sleep-wake behaviour in severe chronic insomnia European Neurology. 1987
- Effects of delta sleep-inducing peptide on sleep of chronic insomniac patients. A double-blind study Neuropsychobiology. 1992
- Epithalon peptide induces telomerase activity and telomere elongation in human somatic cells Bulletin of Experimental Biology and Medicine. 2003
- Overview of Epitalon-Highly Bioactive Pineal Tetrapeptide with Promising Properties International Journal of Molecular Sciences. 2025
- Prohibited List (2026 List, in force 1 January 2026) World Anti-Doping Agency. 2026
- ClinicalTrials.gov registry search: emideltide (no registered studies returned, searched 24 October 2026) ClinicalTrials.gov. 2026
- ClinicalTrials.gov registry search: epitalon (one early phase 1 multi-agent study, NCT07888595, returned; searched 24 October 2026) ClinicalTrials.gov. 2026
- Drugs@FDA via openFDA: query for emideltide (no matching application, queried 24 October 2026) openFDA. 2026
For research use only. Not for human or veterinary use. Not a drug, food, or dietary supplement. This page compares published research and is not medical advice or a recommendation.

