# Epitalon

Epitalon is in limbo: it is not approved, and it is on neither FDA list for compounding, so no pharmacy may lawfully make it. The evidence grade is animal-only. No study has tested whether it helps people sleep or age, and nobody knows how safe it is.

Status checked: 2026-10-25. Last verified: 2026-10-25. Primary source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks

This page has not been individually reviewed by a clinician.

Information, not medical advice.

| Fact | Value | Tier | Checked | Source |
|---|---|---|---|---|
| Also called | Epithalon, Epitalon (free base), Epitalon acetate, Ala-Glu-Asp-Gly, AEDG peptide | primary | 2026-10-25 | [source](https://www.fda.gov/media/193345/download) |
| Class | other | primary | 2026-10-25 | [source](https://www.fda.gov/media/193345/download) |
| Regulatory status | limbo | primary | 2026-10-25 | [source](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) |
| Status source read | 2026-10-23 | primary | 2026-10-25 | [source](https://www.fda.gov/media/94155/download) |
| Evidence grade | animal-only | our assessment | 2026-10-25 | [source](https://peptideindex.ai/methodology#evidence-grade) |

## Name

Epitalon

Source: https://www.fda.gov/media/193345/download

## Summary

A chain of four amino acids made in a lab, based on a pineal gland extract. It is in no FDA-approved drug. It is sold for slower aging.

Source: https://www.fda.gov/media/193345/download

## Short answer

Epitalon is in limbo: it is not approved, and it is on neither FDA list for compounding, so no pharmacy may lawfully make it. The evidence grade is animal-only. No study has tested whether it helps people sleep or age, and nobody knows how safe it is.

Source: https://peptideindex.ai/methodology#short-answer

## Known risks

- FDA warns that an Epitalon shot may set off the immune system. Peptides can clump together, which can make this worse [^1] [^6].
- Epitalon switches on telomerase in lab cells, and long telomeres are linked to cancer. FDA warns that long use could help cells turn cancerous [^6] [^8].
- The mouse tumor studies were short, used only female mice and tested one amount. FDA says they cannot rule out a cancer risk [^6].
- FDA says the name Epitalon is used for more than one form. A product sold as Epitalon may not hold the form a doctor ordered [^6].
- FDA warns that shots made outside drug rules can carry germs or toxins straight into the blood. That can cause a life-threatening illness [^9].

Source: https://www.fda.gov/media/193345/download

## What nobody knows yet

- FDA reviewed Epitalon for insomnia. No study has tested whether it helps people who have it [^6].
- No study has checked how safe Epitalon is in people, or how the body takes it up and clears it [^6].
- The longer life seen in studies came from mice. Nobody knows if Epitalon slows aging in people [^6] [^16].
- No two-year cancer study has been done in animals. Nobody knows the cancer risk of long-term use [^6].
- Melatonin falls with age, but low melatonin has not been clearly linked to insomnia in older adults. Nobody knows if raising it with Epitalon helps [^6].

Source: https://www.fda.gov/media/193345/download

## What it is

Epitalon is a chain of four amino acids [^6]. Amino acids are the building blocks of proteins. It is made in a lab. Its design was based on an extract from the pineal gland of cattle [^6]. The pineal gland is a small gland in the brain. It makes melatonin, a hormone that helps control sleep [^6]. FDA treats Epitalon and that extract, called epithalamin, as different substances [^6].

Epitalon is part of no FDA-approved drug and has no official quality standard [^6]. It is sold as a free base and as an acetate salt, and FDA treats them as two different substances [^6]. Websites and clinics promote it for slower aging, longer life, better sleep and many other uses [^6]. It once had an orphan drug designation for an inherited eye disease. That designation was withdrawn in 2016, and it was never an approval [^6].

Source: https://www.fda.gov/media/193345/download

## Where it stands legally

Epitalon is in limbo: FDA lists it among the Category 2 substances whose nominations were withdrawn, and it has not added it to Category 1 [^1] [^2]. That is not approval, and it does not make compounding lawful. FDA's meeting notice lists insomnia as the one use it reviewed, but websites sell Epitalon mostly for slower aging and longer life [^4] [^6]. Checked 23 October 2026.

Category 2 is FDA's list of substances that may present significant safety risks. Category 1 is the list of substances pharmacies may use while FDA reviews them [^3]. The groups that nominated Epitalon withdrew their nominations, so it came off Category 2 [^1] [^6]. FDA then reviewed it on its own. FDA's scientists found no study of its safety in people and advised against adding it to the list [^6] [^8]. FDA did not review the other uses named in the nominations, such as anti-aging [^6].

On 24 July 2026, FDA's Pharmacy Compounding Advisory Committee met on Epitalon [^4] [^5] [^7]. One legal report says the committee voted 7 to 4, with 1 member abstaining, to recommend adding it to the list [^11]. News and other legal reports also name Epitalon among the peptides the committee backed [^12] [^13] [^21]. FDA's meeting page does not show the vote [^5]. A committee vote is only advice [^11]. FDA decides by writing a rule, after public comment [^11] [^22].

Until then, a pharmacy that makes Epitalon is outside federal law [^3] [^11]. In 2020, a Kentucky compounding pharmacy pleaded guilty to distributing unapproved new drugs, Epitalon among them [^10]. Selling Epitalon for people to use is also illegal, even when the label says it is for research only [^9] [^13].

Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks

## What the evidence shows

The evidence grade is animal-only: the studies that show an effect on health used mice or cells, and no study has tested whether Epitalon helps people sleep or age better [^6]. Most Epitalon studies, including the few in people, come from one research group in Russia [^6] [^15].

People: in a small study, 20 women aged 40 to 50 who worked night shifts took Epitalon under the tongue for 20 days [^6] [^14]. A melatonin marker in their urine rose, while it did not change with a placebo [^6] [^14]. The study did not measure sleep and did not report safety. Its full report is in Russian [^6] [^14]. FDA says a change in melatonin means little without a change in health [^6].

Melatonin falls with age, and websites say Epitalon restores it [^6] [^15]. A level that falls with age is not evidence that taking Epitalon helps. Low melatonin has not been clearly linked to insomnia in older adults [^6].

Animals: female mice got Epitalon shots under the skin for a few days each month. It did not change their average life span. The longest-lived mice lived a little longer, and one blood cancer was less common [^16]. In mice bred to get breast tumors, treated mice had fewer and smaller tumors [^17]. In old female monkeys, it raised evening melatonin, but nobody measured their sleep [^6]. In rat pineal glands kept alive in a lab device, it did not raise melatonin [^18].

Cells: in human fetal cells in a lab dish, Epitalon switched on telomerase and lengthened telomeres [^19]. Telomeres are caps on the ends of chromosomes that shorten as cells age. A 2025 lab study by a London group found the same in human cell lines, including breast cancer cells [^20]. FDA says this same effect raises a cancer concern [^6].

Source: https://www.fda.gov/media/193345/download

## Legitimate ways to get it

There is no legal way to get Epitalon in the US today [^6]. No approved drug contains it. No product with it is approved in Europe, Canada, Australia or the UK [^6]. A pharmacy may use a substance with no official quality standard only if it is in an approved drug or on the federal list. Epitalon is neither [^3] [^6]. That could change if FDA adds it by writing a rule after the committee vote [^11] [^13].

FDA found no clinical study of Epitalon's safety in people [^6]. One study in the US registry includes Epitalon in a skin serum, but only invited people can join, so it is not an open trial [^23]. Any open trial that gives Epitalon would appear in the trials block below, with the date the official registry was last checked. FDA notes that approved drugs for insomnia already exist [^6].

Source: https://www.fda.gov/media/193345/download

## How people are getting it anyway

This section describes what happens and is not a recommendation.

People who use Epitalon get it in three main ways [^6]. The first is websites that sell it as vials, capsules or a mouth spray [^6]. Several of these sites say the product is for research use only [^6]. FDA says that label does not make it legal to sell a drug meant for people [^9] [^12]. The second is pharmacies. Some clinics say they get Epitalon from a compounding pharmacy, though FDA could not find one that makes it [^6]. In 2020, one compounding pharmacy pleaded guilty to selling it and other unapproved drugs [^10]. The third is clinics. Wellness clinics and concierge doctors promote it for anti-aging [^6] [^8].

In all three, nobody checks what is in the product the way FDA checks an approved drug. FDA found no test results for clumps or germ toxins in Epitalon powder offered for shots [^6]. FDA found no reports of harm from Epitalon in its files. FDA says that does not show it is free of harm, because reporting is voluntary and pharmacies seldom report [^6] [^8].

Source: https://www.fda.gov/media/193345/download

## Access routes

Source: https://www.fda.gov/media/193345/download

### None

Detail: There is no legal route to Epitalon in the US today. It is in no approved drug, has no official quality standard, and is not on the list pharmacies may use.

Source: https://www.fda.gov/media/193345/download

## Unofficial channels

Source: https://www.fda.gov/media/193345/download

### Research use seller

What it is: Sold on websites as vials, capsules or a mouth spray, often with a label saying it is for research use only.

Legal position: FDA treats these products as unapproved new drugs when the seller's claims show they are meant for people, whatever the label says. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026)

Documented risks:

- FDA warns that injected drugs bypass some of the body's defenses and can carry toxins or germs that cause life-threatening illness. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026)
- FDA says products sold under the name Epitalon can hold different forms, so a person may get a different substance than the one a doctor ordered. (source: https://www.fda.gov/media/193345/download)

Enforcement:

- 2026-08-24: FDA warning letter to an online seller of research-use peptide shots. The letter did not name Epitalon. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026)

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026

### Compounding outside the rules

What it is: Made by a pharmacy from bulk Epitalon powder. Some clinics say they get Epitalon from compounding pharmacies.

Legal position: Epitalon has no official quality standard, is in no approved drug and is not on the federal list, so a pharmacy may not compound it under section 503A. (source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act)

Documented risks:

- FDA found no study of Epitalon's safety in people, so the safety of a compounded product is unknown. (source: https://www.fda.gov/media/193345/download)
- FDA found no test results for clumps or germ toxins in Epitalon powder offered for making shots. (source: https://www.fda.gov/media/193345/download)

Enforcement:

- 2020-10-29: US Department of Justice: a Kentucky compounding pharmacy and its owner pleaded guilty to distributing unapproved new drugs, Epitalon among them. (source: https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution)

Source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act

### Clinic or med spa

What it is: Wellness clinics and concierge doctors that promote Epitalon for anti-aging, some saying a compounding pharmacy makes it.

Legal position: A clinic's prescription does not make Epitalon lawful to compound. It is still a substance that is not on the federal list. (source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act)

Documented risks:

- FDA has not found safety information on Epitalon for the route proposed, so it cannot say whether it would cause harm. (source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks)
- FDA warns that Epitalon's effect on telomeres raises a concern that long use could help cells turn cancerous. (source: https://www.fda.gov/media/193345/download)

Source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act

## Recruiting trials

Snapshot date: 2026-10-25.

A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record.

None in this snapshot.

Source: https://clinicaltrials.gov/api/v2/studies?query.intr=Epitalon+OR+Epithalon+OR+Epitalon+acetate&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState

## Sources

Source: https://www.fda.gov/media/193345/download

### 1. FDA: bulk drug substances that may present significant safety risks, including those withdrawn from Category 2

Type: regulatory

Tier: primary

Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks

### 2. FDA: bulk drug substances nominated under section 503A, list updated 14 May 2026

Type: regulatory

Tier: primary

Source: https://www.fda.gov/media/94155/download

### 3. FDA: bulk drug substances used in compounding under section 503A

Type: regulatory

Tier: primary

Source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act

### 4. Federal Register: notice of the July 2026 Pharmacy Compounding Advisory Committee meeting

Type: regulatory

Tier: primary

Source: https://www.federalregister.gov/documents/full_text/html/2026/04/16/2026-07361.html

### 5. FDA: Pharmacy Compounding Advisory Committee meeting, 23 and 24 July 2026

Type: regulatory

Tier: primary

Source: https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026

### 6. FDA briefing document on Epitalon for the July 2026 committee meeting, 12 May 2026

Type: regulatory

Tier: primary

Source: https://www.fda.gov/media/193345/download

### 7. FDA: questions put to the committee at the July 2026 meeting

Type: regulatory

Tier: primary

Source: https://www.fda.gov/media/193711/download

### 8. FDA: presentations to the committee on 24 July 2026, including Epitalon

Type: regulatory

Tier: primary

Source: https://www.fda.gov/media/193774/download

### 9. FDA warning letter to an online seller of research-use peptides, 24 August 2026

Type: regulatory

Tier: primary

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026

### 10. US Department of Justice: a Kentucky compounding pharmacy pleads guilty to distributing unapproved drugs, 29 October 2020

Type: regulatory

Tier: primary

Source: https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution

### 11. McDermott Will & Schulte: what the July 2026 committee votes on peptides mean

Type: legal-analysis

Tier: legal-analysis

Source: https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/

### 12. Sheppard Mullin: FDA's peptide policy and its warning letters to peptide sellers

Type: legal-analysis

Tier: legal-analysis

Source: https://www.sheppard.com/insights/blogs/fda-balances-peptide-policy-with-enforcement-against-unlawful-peptide-sellers

### 13. ArentFox Schiff: a research-use-only label does not make selling peptides legal

Type: legal-analysis

Tier: legal-analysis

Source: https://www.afslaw.com/perspectives/alerts/ruo-ined-five-peptide-vendors-learn-research-use-only-not-legal-strategy

### 14. Epitalon (AEDG peptide), melatonin and body-clock genes in night-shift workers, 2020, in Russian

Type: human-trial

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/33280326/

### 15. Review: pineal gland aging and pineal peptides, 2012, in Russian

Type: reference

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/22567846/

### 16. Epitalon on aging, life span and tumors in female mice, 2003

Type: animal

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/14501183/

### 17. Epitalon on breast tumors in mice bred to develop them, 2002

Type: animal

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/12209581/

### 18. The same peptide on melatonin release from young and old rat pineal glands in the lab, 2003

Type: in-vitro

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/12809170/

### 19. Epitalon on telomerase and telomeres in human fetal cells in the lab, 2003

Type: in-vitro

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/12937682/

### 20. Epitalon on telomere length in human cell lines in the lab, 2025

Type: in-vitro

Tier: peer-reviewed

Source: https://pubmed.ncbi.nlm.nih.gov/40908429/

### 21. NPR: FDA advisers vote to ease peptide limits despite agency concerns, 23 July 2026

Type: reference

Tier: established-news

Source: https://www.npr.org/2026/07/23/nx-s1-5903202/fda-peptides-restrictions

### 22. NBC News: FDA panel recommends easing peptide limits despite agency scientists

Type: reference

Tier: established-news

Source: https://www.nbcnews.com/health/health-news/peptides-restrictions-ease-fda-panel-recommend-bpc-157-scientists-rcna588879

### 23. ClinicalTrials.gov: an aging study with a peptide skin serum that includes Epitalon, enrolling by invitation

Type: reference

Tier: primary

Source: https://clinicaltrials.gov/study/NCT07888595

Last verified: 2026-10-25.

Sources:

- https://clinicaltrials.gov/api/v2/studies?query.intr=Epitalon+OR+Epithalon+OR+Epitalon+acetate&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState
- https://peptideindex.ai/methodology#evidence-grade
- https://peptideindex.ai/methodology#short-answer
- https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
- https://www.fda.gov/media/193345/download
- https://www.fda.gov/media/94155/download

[^1]: FDA: bulk drug substances that may present significant safety risks, including those withdrawn from Category 2 https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
[^2]: FDA: bulk drug substances nominated under section 503A, list updated 14 May 2026 https://www.fda.gov/media/94155/download
[^3]: FDA: bulk drug substances used in compounding under section 503A https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
[^4]: Federal Register: notice of the July 2026 Pharmacy Compounding Advisory Committee meeting https://www.federalregister.gov/documents/full_text/html/2026/04/16/2026-07361.html
[^5]: FDA: Pharmacy Compounding Advisory Committee meeting, 23 and 24 July 2026 https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026
[^6]: FDA briefing document on Epitalon for the July 2026 committee meeting, 12 May 2026 https://www.fda.gov/media/193345/download
[^7]: FDA: questions put to the committee at the July 2026 meeting https://www.fda.gov/media/193711/download
[^8]: FDA: presentations to the committee on 24 July 2026, including Epitalon https://www.fda.gov/media/193774/download
[^9]: FDA warning letter to an online seller of research-use peptides, 24 August 2026 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026
[^10]: US Department of Justice: a Kentucky compounding pharmacy pleads guilty to distributing unapproved drugs, 29 October 2020 https://www.justice.gov/usao-edky/pr/nicholasville-compounding-pharmacy-and-its-owner-plead-guilty-unlawful-distribution
[^11]: McDermott Will & Schulte: what the July 2026 committee votes on peptides mean https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/
[^12]: Sheppard Mullin: FDA's peptide policy and its warning letters to peptide sellers https://www.sheppard.com/insights/blogs/fda-balances-peptide-policy-with-enforcement-against-unlawful-peptide-sellers
[^13]: ArentFox Schiff: a research-use-only label does not make selling peptides legal https://www.afslaw.com/perspectives/alerts/ruo-ined-five-peptide-vendors-learn-research-use-only-not-legal-strategy
[^14]: Epitalon (AEDG peptide), melatonin and body-clock genes in night-shift workers, 2020, in Russian https://pubmed.ncbi.nlm.nih.gov/33280326/
[^15]: Review: pineal gland aging and pineal peptides, 2012, in Russian https://pubmed.ncbi.nlm.nih.gov/22567846/
[^16]: Epitalon on aging, life span and tumors in female mice, 2003 https://pubmed.ncbi.nlm.nih.gov/14501183/
[^17]: Epitalon on breast tumors in mice bred to develop them, 2002 https://pubmed.ncbi.nlm.nih.gov/12209581/
[^18]: The same peptide on melatonin release from young and old rat pineal glands in the lab, 2003 https://pubmed.ncbi.nlm.nih.gov/12809170/
[^19]: Epitalon on telomerase and telomeres in human fetal cells in the lab, 2003 https://pubmed.ncbi.nlm.nih.gov/12937682/
[^20]: Epitalon on telomere length in human cell lines in the lab, 2025 https://pubmed.ncbi.nlm.nih.gov/40908429/
[^21]: NPR: FDA advisers vote to ease peptide limits despite agency concerns, 23 July 2026 https://www.npr.org/2026/07/23/nx-s1-5903202/fda-peptides-restrictions
[^22]: NBC News: FDA panel recommends easing peptide limits despite agency scientists https://www.nbcnews.com/health/health-news/peptides-restrictions-ease-fda-panel-recommend-bpc-157-scientists-rcna588879
[^23]: ClinicalTrials.gov: an aging study with a peptide skin serum that includes Epitalon, enrolling by invitation https://clinicaltrials.gov/study/NCT07888595