§ — Researched for · Sleep & recovery
No peptide has a proven, approved use for sleep. The candidates discussed — emideltide (DSIP), epitalon, and GH secretagogues — rest on decades-old inconsistent studies or on animal data, and FDA proposed in 2026 not to list the first two for compounding.
Reviewed September 2026 · Sources: FDA, EMA
02 — What is being studied
Two mechanisms are under study. One is direct sleep signalling: delta-sleep-inducing peptide was isolated from rabbit cerebral venous blood in the 1970s and tested in small human studies with inconsistent results on sleep latency and slow-wave sleep. The other is indirect, through the growth hormone axis, since GH secretion is coupled to slow-wave sleep and secretagogues shift that pattern.
The endpoints that would settle the question — polysomnography-confirmed sleep architecture, sleep efficiency, next-day function, all against placebo — have not been measured in modern controlled trials for any peptide in this group. Epitalon rests on Russian-language work with pineal regulation as its stated mechanism and no published clinical sleep data. Animal and mechanistic plausibility is not an outcome, and as of September 2026 this group has plausibility without outcomes.
03 — The table
| Peptide | Researched for | Evidence | Regulatory status | As of |
|---|---|---|---|---|
| CJC-1295 | Sustained growth hormone and IGF-1 elevation in adults; body composition. | B | Not FDA-approved. Removed from 503A Category 2 in April 2026 following nomination withdrawal; not placed in Category 1. Compounding not covered by the 503A exemption. | 2026-09-06 |
| Ipamorelin | Postoperative ileus (a completed phase 2 program); growth hormone release. | B | Not FDA-approved. Placed in 503A Category 2 in 2023. Its current category must be verified against the FDA bulks list before publication; it has not been listed in Category 1. | 2026-09-06 |
| Emideltide | Sleep induction, stress response, chronic pain, opioid withdrawal. | C | Not FDA-approved. Reviewed by PCAC on July 24, 2026; FDA proposed not to add it to the 503A Bulks List. | 2026-09-06 |
| Epitalon | Telomerase activation, melatonin regulation, lifespan extension. | D | Not FDA-approved. Reviewed by PCAC on July 24, 2026; FDA proposed not to add it to the 503A Bulks List. | 2026-09-06 |
04 — Per peptide
Regulatory status · United States · as of September 2026
Not FDA-approved. Removed from 503A Category 2 in April 2026 following nomination withdrawal; not placed in Category 1. Compounding not covered by the 503A exemption.
Source: FDA 503A Bulks List · PCAC meeting records · verified September 2026
Researched forSustained growth hormone and IGF-1 elevation in adults; body composition.
Full profile: CJC-1295 →Regulatory status · United States · as of September 2026
Not FDA-approved. Placed in 503A Category 2 in 2023. Its current category must be verified against the FDA bulks list before publication; it has not been listed in Category 1.
Source: FDA 503A Bulks List · PCAC meeting records · verified September 2026
Researched forPostoperative ileus (a completed phase 2 program); growth hormone release.
Full profile: Ipamorelin →Regulatory status · United States · as of September 2026
Not FDA-approved. Reviewed by PCAC on July 24, 2026; FDA proposed not to add it to the 503A Bulks List.
Source: FDA 503A Bulks List · PCAC meeting records · verified September 2026
Researched forSleep induction, stress response, chronic pain, opioid withdrawal.
Full profile: Emideltide →Regulatory status · United States · as of September 2026
Not FDA-approved. Reviewed by PCAC on July 24, 2026; FDA proposed not to add it to the 503A Bulks List.
Source: FDA 503A Bulks List · PCAC meeting records · verified September 2026
Researched forTelomerase activation, melatonin regulation, lifespan extension.
Full profile: Epitalon →05 — What the data does not show
Reliable improvement in sleep quality or recovery has not been shown for any peptide in this group.
06 — Questions for your physician
Listing in the registry is not an endorsement of any substance or protocol, and it is not a statement that a treatment is approved.
Reviewed September 2026 · Sources: FDA, EMA
This page reports on the state of research and regulation for orientation. It is not medical advice, not a recommendation for or against any substance, and not an offer. Regulatory status changes; the date shown is the date of our last verification. Discuss any treatment with a licensed physician.