# Epitalon: FDA Status, Research and Uses

> Epitalon (epithalon) facts: FDA compounding status, the July 2026 advisory committee review, WADA status, studies and doses used in research.

- Canonical URL: https://livingpluspeptides.com/peptides/epitalon/
- Last updated: October 28, 2026
- Publisher: Living+

Epitalon is a 4-amino-acid peptide (Ala-Glu-Asp-Gly) modeled on a pineal gland extract. It is not FDA approved or on the 503A bulks list [1, 13]. FDA staff proposed not listing it in July 2026 [3, 4]. Since October 28, 2026, an HHS interim policy covers compounding it under set conditions [13]. Research is mostly animal and small Russian studies [1].

## Regulatory status

- FDA approved: No
- 503A compounding: [HHS interim enforcement policy (may be compounded under its conditions while FDA writes the 503A bulks list rule; not FDA approval)](https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf). On HHS's interim enforcement policy (Appendix A), released Oct 28, 2026. HHS does not intend to take action against a state-licensed pharmacy, federal facility or licensed physician compounding epitalon acetate for subcutaneous or intramuscular injection, given in intermittent courses, with a patient-specific prescription and the policy's other conditions (FDA-registered source with a certificate of analysis, single ingredient, adverse event reporting). It is not FDA approval and not a place on the 503A bulks list; HHS may revisit it if a safety or quality problem arises. The July 2026 advisory committee voted in favor of listing it, and FDA's final rule is still pending.
- 503B bulks list: [Not nominated](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/UCM467374.pdf). Not on FDA's 503B categories list (updated March 21, 2025). FDA says no outsourcing facility has reported compounding epitalon.
- WADA prohibited: [Unclear](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf) (Not named on the 2026 or 2027 List. S0 (non-approved substances) may apply, since it covers substances no government has approved for human use. The 2027 List, in force January 1, 2027, adds peptides as an S0 example.)
- FDA drug shortage: [Not on the shortage list](https://api.fda.gov/drug/shortages.json?search=generic_name:%22epitalon%22)
- DEA schedule: [Not scheduled](https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf)
- Last verified: October 28, 2026

Checked against: [HHS: Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances (Appendix A and B)](https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf), [Federal Register: HHS notice of availability, FR Doc. 2026-22192 (filed Oct 28, 2026; publishes Oct 30, 2026)](https://public-inspection.federalregister.gov/2026-22192.pdf), [FDA briefing document: epitalon, PCAC July 23-24, 2026](https://www.fda.gov/media/193345/download), [FDA briefing document introduction, PCAC July 23-24, 2026](https://www.fda.gov/media/193342/download), [FDA: July 23-24, 2026 PCAC meeting page](https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026), [FDA: Certain bulk drug substances for use in compounding that may present significant safety risks](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks), [WADA: 2026 Prohibited List (PDF), S0 non-approved substances](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf), [openFDA Drugs@FDA query: epitalon (no matches)](https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22epitalon%22), [openFDA drug shortages query: epitalon](https://api.fda.gov/drug/shortages.json?search=generic_name:%22epitalon%22), [DEA Diversion: Controlled Substances - Alphabetical Order](https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf)

## Key facts

- Class: Synthetic pineal gland tetrapeptide [1, 7]
- Amino-acid length: 4 amino acids (Ala-Glu-Asp-Gly) [1]
- Half-life: Not established; FDA found no pharmacokinetic data [1]
- Route used in studies: Under the tongue and near the eye in human studies; under the skin in mice [1, 7]
- First studied: Late 1980s or 1999 (FDA's review gives both dates) [1]

## How it works

Epitalon is a synthetic peptide of four amino acids. It was designed from the amino acid makeup of epithalamin, an extract from cattle pineal glands. FDA treats epitalon and epithalamin as different substances, so studies of the extract do not count as studies of epitalon [1].

The pineal gland makes melatonin, a hormone that helps set the sleep-wake cycle. In old female rhesus monkeys, epitalon raised evening melatonin and restored the normal daily rhythm of cortisol [1, 9]. In a small study of middle-aged women with low melatonin markers, an under-the-tongue spray raised a urine melatonin marker 1.7-fold [1, 11]. FDA did not find any studies of epitalon in people with insomnia [1].

Lab studies point to a second effect. In human fetal lung cells, epitalon turned on telomerase, the enzyme that lengthens telomeres at the ends of chromosomes, and telomeres grew longer [8]. In mice, it did not change average lifespan but raised maximum lifespan by 12.3% [7].

FDA cautions that turning on telomerase could also raise cancer risk with long-term use, and that the mouse studies were too short to judge this [1]. FDA notes that most pharmacology studies of epitalon come from one Russian research group [1].

## What the research shows

| Study | Year | Participants | Design | Result | Link |
| --- | --- | --- | --- | --- | --- |
| Human trial: Ivko et al. 2020 (night shift workers) | 2020 | 75 women aged 40 to 50 working night shifts; 40 with low melatonin markers were randomized | Placebo-controlled, under-the-tongue spray twice daily for 20 days [1] | Epitalon was studied for melatonin output; a urine melatonin marker rose 1.7-fold. FDA notes sleep was not measured [1, 11]. | [Source](https://pubmed.ncbi.nlm.nih.gov/33280326/) |
| Human trial: Khavinson et al. 2002 (retinitis pigmentosa) | 2002 | Patients with retinitis pigmentosa; Campbell rats | Clinical and animal study; injection near the eye in patients [1, 10] | Epitalon was studied for inherited retinal disease; authors reported a positive clinical effect in 90% of cases, with few details [10]. | [Source](https://pubmed.ncbi.nlm.nih.gov/12195242/) |
| Animal study: Anisimov et al. 2003 (lifespan in mice) | 2003 | Female SHR mice (54 per group) | Controlled lifelong study, 5 days of dosing each month [7] | No change in average lifespan. Maximum lifespan rose 12.3% and leukemia was less frequent [7]. | [Source](https://pubmed.ncbi.nlm.nih.gov/14501183/) |
| Animal study: Goncharova et al. 2001 (old monkeys) | 2001 | Female rhesus monkeys | Controlled study, daily dosing for 10 days [1, 9] | Epitalon raised evening melatonin and restored the daily cortisol rhythm in old monkeys [9]. | [Source](https://pubmed.ncbi.nlm.nih.gov/11550036/) |
| Lab study: Khavinson et al. 2003 (telomerase) | 2003 | Cell culture (human fetal fibroblasts) | Lab study [8] | Epitalon turned on telomerase and lengthened telomeres in these cells [8]. | [Source](https://pubmed.ncbi.nlm.nih.gov/12937682/) |

## Doses used in studies

In the human melatonin study, women used an under-the-tongue spray twice a day for 20 days, which the authors said gave 0.5 mg of peptide per day [1]. FDA found no human studies that used injection under the skin [1].

In the mouse lifespan study, mice received 1.0 microgram each (about 30 to 40 mcg/kg) under the skin on 5 days in a row every month [7]. The cell study used 50 ng/mL for 4 days [1].

**Dosing is set by a licensed provider.**

## Side effects and safety

Epitalon is not FDA approved, so there is no FDA label or boxed warning. FDA found no clinical studies that assessed its safety in humans and no pharmacokinetic data [1]. A search of FDA's adverse event database found no reports [1].

One abstract claimed pineal peptides had no side effects in elderly people, but gave no details on dose, route or how safety was checked [1]. The 20-day melatonin study did not report safety data [1].

FDA's main concern is cancer. Because epitalon turns on telomerase and lengthens telomeres, FDA says continuous long-term use could help cells avoid aging and become cancerous, and no 2-year cancer studies exist [1]. FDA also says compounded epitalon may carry a risk of immune reactions because of clumping and impurities [2].

- [FDA: Certain bulk drug substances for use in compounding that may present significant safety risks](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) (2026-04-22)

## Legal and regulatory status

- 2026-10-28: HHS issued an interim enforcement policy for certain peptides used in 503A compounding. Until a final rule decides whether epitalon goes on the 503A bulks list, HHS does not intend to take action against state-licensed pharmacies, federal facilities or licensed physicians who compound it under the policy's conditions [13]. For epitalon acetate, the policy covers subcutaneous or intramuscular injectable forms dispensed in intermittent courses [13]. Conditions include a single active ingredient, bulk substance from an FDA-registered facility with a certificate of analysis, reporting of serious adverse events to FDA and a patient-specific prescription [13]. The policy is not FDA approval and does not place epitalon on the 503A bulks list [13]. HHS may revisit it if a safety signal or product quality issue arises [13]. A Federal Register notice of availability, which calls the policy a draft, publishes October 30, 2026 [14]. [Source](https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf)
- 2026-07-24: FDA's Pharmacy Compounding Advisory Committee discussed epitalon (free base) and epitalon acetate for insomnia. FDA proposed that neither be placed on the 503A bulks list [3, 4]. HHS's October 28, 2026 policy states the committee voted in favor of inclusion [13]. [Source](https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026)
- 2026-04-22: FDA's safety risk page, updated this date, lists epitalon among substances whose nominations were withdrawn. FDA is still evaluating it on its own [1, 2]. [Source](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks)
- 2026-04-16: FDA announced the July 2026 advisory committee meeting in the Federal Register, listing epitalon for review [5]. [Source](https://public-inspection.federalregister.gov/2026-07361.pdf)
- 2026-01-01: The WADA 2026 Prohibited List took effect. Epitalon is not named, but the S0 class bans substances with no government approval for human use [6, 12]. [Source](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf)
- 2016-01-06: An FDA orphan drug designation for epitalon in retinitis pigmentosa, granted September 2, 2010, was withdrawn or revoked, according to FDA's review [1]. [Source](https://www.fda.gov/media/193345/download)

See every peptide's status side by side in the [Peptide Status Tracker](https://livingpluspeptides.com/regulation/tracker/#row-epitalon).

## Frequently asked questions

### Is epitalon FDA approved?

No. FDA states epitalon is not a component of an FDA-approved drug and found no approved epitalon products in the countries it checked [1].

### Is epitalon the same as epithalon or epithalamin?

Epithalon is another name for epitalon. Epithalamin is a different substance, a pineal gland extract from cattle [1].

### Is epitalon legal to compound?

Epitalon is still not on the 503A bulks list and is not FDA approved, and FDA's final rule is pending [1, 13]. FDA staff proposed not to list it in July 2026 [3, 4]. Since October 28, 2026, an HHS interim policy says HHS does not intend to take action against state-licensed pharmacies, federal facilities or licensed physicians who compound epitalon acetate under set conditions [13]. It covers subcutaneous or intramuscular injectable forms dispensed in intermittent courses [13]. The policy is not FDA approval, and HHS may revisit it [13].

### Does epitalon lengthen telomeres?

In a lab study of human fetal cells it turned on telomerase and lengthened telomeres [8]. This has not been shown in people, and FDA flags a possible cancer risk [1].

### Does epitalon help sleep?

FDA reviewed it for insomnia and found no studies in people with insomnia. One small study found a higher urine melatonin marker but did not measure sleep [1].

### Is epitalon banned in sports?

It is not named on the 2026 WADA List, but the S0 class bans substances with no government approval for human use. Athletes should check with their anti-doping body [6].

### Is epitalon safe?

Its safety in humans is not established. FDA found no clinical safety studies and raised cancer and immune reaction concerns [1, 2].

### Did epitalon extend lifespan in animals?

In one mouse study it did not change average lifespan but raised maximum lifespan by 12.3% [7].

## Sources

1. [FDA briefing document: evaluation of epitalon-related bulk drug substances, PCAC July 23-24, 2026](https://www.fda.gov/media/193345/download)
2. [FDA: Certain bulk drug substances for use in compounding that may present significant safety risks](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks)
3. [FDA: July 23-24, 2026 meeting of the Pharmacy Compounding Advisory Committee](https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026)
4. [FDA briefing document introduction, PCAC July 23-24, 2026](https://www.fda.gov/media/193342/download)
5. [Federal Register: PCAC notice of meeting, published April 16, 2026](https://public-inspection.federalregister.gov/2026-07361.pdf)
6. [WADA: 2026 Prohibited List (PDF), S0 non-approved substances](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf)
7. [Anisimov et al. 2003, Biogerontology (PubMed)](https://pubmed.ncbi.nlm.nih.gov/14501183/)
8. [Khavinson et al. 2003, Bull Exp Biol Med (PubMed)](https://pubmed.ncbi.nlm.nih.gov/12937682/)
9. [Goncharova et al. 2001, Bull Exp Biol Med (PubMed)](https://pubmed.ncbi.nlm.nih.gov/11550036/)
10. [Khavinson et al. 2002, Neuro Endocrinol Lett (PubMed)](https://pubmed.ncbi.nlm.nih.gov/12195242/)
11. [Ivko et al. 2020, Adv Gerontol (PubMed)](https://pubmed.ncbi.nlm.nih.gov/33280326/)
12. [WADA: Prohibited List resource page (2026 List in force)](https://www.wada-ama.org/en/resources/world-anti-doping-code-and-international-standards/prohibited-list)
13. [HHS: Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances (Oct 28, 2026)](https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf)
14. [Federal Register: HHS notice of availability, FR Doc. 2026-22192 (publishes Oct 30, 2026)](https://public-inspection.federalregister.gov/2026-22192.pdf)

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