A synthetic tetrapeptide discussed in FDA briefing material for a 2026 pharmacy-compounding advisory-committee meeting.↗↗
Citation markers ↗ open the public records supporting the adjacent statements.
Correction · September 15, 2026
We narrowed the status wording to what the dated FDA briefing establishes. A briefing prepared for an advisory process does not establish the current absence of a later final decision. Related substance identities remain distinct. 1
FDA compounding assessment in the cited records. FDA's July 2026 briefing evaluates epitalon free base and acetate and distinguishes the tetrapeptide from epithalamin, a pineal-gland extract. The briefing is an advisory-process assessment, not a final regulatory determination.↗
Review source snapshots checked September 15, 2026 · Integrity checked not available.
Two selected reports discuss the tetrapeptide epitalon/AEDG: a mixed animal-and-human retinal report and a human circadian-biomarker report. This is not a review of the distinct pineal extract epithalamin.↗↗
What the reviewed sources report
These reports describe retinal findings and changes in melatonin-related or gene-expression measurements. Their abstracts do not provide enough detail to establish a reliable treatment effect, long-term safety or an effect on human lifespan.↗↗
What remains unresolved?
Which translated or related reports describe the same participants?↗↗
Do controlled studies assess patient-important outcomes and adequately report adverse events?↗↗
Melatonin measurements do not establish an insomnia benefit
FDA’s July 2026 briefing found no studies evaluating the nominated substances in patients with insomnia. Changes in melatonin or its metabolites were not accompanied by clinical outcomes establishing that proposed use. FDA PDF pp. 40 ↗
More findings and the sources behind them
Selected FDA advisory-briefing sections, not a final agency ruling. The source date identifies the committee meeting (July 23–24 for the 2026 packages), not a new approval or final decision.
Human exposure is different from an adequate safety study
The briefing describes a 20-person exposure report without safety data and an abstract making a safety claim without essential methods. FDA also notes that it could not evaluate one Russian-language full article in English. FDA PDF pp. 36, 37 ↗
No reported events is not proof of safety
FDA’s cited adverse-event searches retrieved no reports, but the briefing explains voluntary-reporting and information limits. It separately found insufficient clinical safety data, especially for the proposed subcutaneous route. FDA PDF pp. 36, 38 ↗
Preclinical findings leave unresolved questions
FDA considered the animal studies too limited in duration and design to characterize genotoxic or carcinogenic potential. Mechanistic concerns in the briefing are not proof that epitalon causes cancer in people. FDA PDF pp. 40 ↗
What remains to be checked
Check subsequent advisory records and any final FDA action separately from the staff briefing.
Retrieve and appraise the original human reports and proposed formulation or route; agency search findings are dated and do not establish a complete worldwide literature review.
Source dates and review coverage
PDF citations use file page numbers. Named webpage sections and registry fields identify the portions read. These are selected readings, not complete source coverage.
Search and screening record checked 2026-09-15. Counts describe records, not independent trials. Full-text appraisal is separate from an abstract review.
Primary human administration reports for the specified molecule; other peptides, preclinical experiments and secondary reviews are separate.
140 retrieved · 2 included · 0 excluded · 138 awaiting a decision · 0 full-text appraisals
Search terms, record decisions and remaining work
"epitalon"[Title/Abstract] OR "epithalon"[Title/Abstract] OR "AEDG"[Title/Abstract]
Regulator and trial-registry searches and non-indexed reports require separate reconciliation.
Full-text appraisal, study-family linkage and citation follow-up remain open.
Showing 25 of 140 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
PubMed 33280326 — include: Selected human report; abstract and record metadata reviewed. Study families: AEDG-2020-2021-circadian-reports-linkage-unresolved.
PubMed 12195242 — include: Selected human report; abstract and record metadata reviewed. Study families: epitalon-2002-retinal-report.
PubMed 42209466 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 42021992 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 41490200 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 41240216 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 41020860 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 40908429 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 40493162 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 40141333 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 39788414 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 39518916 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 38430634 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 39742404 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 36979488 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 37042594 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 35890947 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 35413689 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 35408963 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 34502859 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 34998008 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 33993656 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 32987757 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 31808038 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
PubMed 31677028 — not screened: Retrieved record; clinical eligibility has not yet been adjudicated.
FDA search
Active-ingredient name query in openFDA Drugs@FDA. Returned application identities include salt forms and combination products; exact indications, approval conditions, supplements and marketing status require document-level review.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Zero results describe this query response only, not absence of FDA approval or worldwide nonapproval.
This endpoint does not inventory every label, advisory proceeding, safety communication or regulatory document. Application inclusion does not establish current marketing or approval of every use.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA search
Local matching in the pinned EMA medicines feed; document matches also use identified EMA product numbers. This is not every national European record.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA search
Local matching in the pinned EMA documents feed; document matches also use identified EMA product numbers. This is not every national European record.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA search
Local matching in the pinned EMA orphans feed; document matches also use identified EMA product numbers. This is not every national European record.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Document appraisal and national European sources remain open.
Zero matches apply only to these feed fields and terms; orphan designation is not approval.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
ClinicalTrials.gov search
ClinicalTrials.gov name/alias discovery, including cited product names. Matches may concern combinations, background references or different formulations; identity and outcomes need screening.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Registration is not evidence that a study succeeded, that results were published, or that a use is approved.
Other registries, unregistered studies and additional aliases remain outside this query.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
Read the full Human Evidence Review
Supervised synthesis
What do selected human studies report about Epitalon?
Two selected reports discuss the tetrapeptide epitalon/AEDG: a mixed animal-and-human retinal report and a human circadian-biomarker report. This is not a review of the distinct pineal extract epithalamin.12
Bottom line from this bounded source set
These reports describe retinal findings and changes in melatonin-related or gene-expression measurements. Their abstracts do not provide enough detail to establish a reliable treatment effect, long-term safety or an effect on human lifespan.12
Reviewed study record
Retinal degeneration: mixed preclinical and clinical report
Design
The publication describes experiments in rats and clinical observations in patients with degenerative retinal lesions.1
Population
The abstract does not state the number of patients or their allocation to a comparator.1
Outcomes reported
The authors reported a positive clinical effect in 90% of cases and retinal effects in rats.1
Limitations
The clinical endpoint, comparator, follow-up and adverse events are insufficiently described in the abstract. The reported percentage is not a controlled effect estimate, and animal findings cannot establish human benefit.1
Reviewed study record
Circadian biomarkers
Design
The report examines AEDG and melatonin-related and clock-gene measurements in people with altered melatonin production.2
Population
The abstract does not give a sufficiently detailed enrollment and allocation account.2
Outcomes reported
The authors reported changes in urinary melatonin metabolite levels and clock-gene expression.2
Limitations
Biomarker changes do not establish better sleep, reduced disease or longer lifespan. Full-text and related-report reconciliation are required to assess design, participant overlap and harms.2
Crossref check unavailableThe reviewed PubMed payload did not include a DOI, so this source could not be matched to a Crossref work endpoint.
Explore status sources, recent additions, and coverage gaps
Living status brief
What is the current status of Epitalon?
FDA compounding assessment in the cited records. FDA's July 2026 briefing evaluates epitalon free base and acetate and distinguishes the tetrapeptide from epithalamin, a pineal-gland extract. The briefing is an advisory-process assessment, not a final regulatory determination.↗
The cited status sources were checked through July 29, 2026. This answer changes only through the profile’s visible version and correction history.
PeptideScanner currently has no selected clinical trial records and safety records connected to this profile. That is a collection gap, not evidence that no such records exist.
PeptideScanner does not infer an answer where the cited records do not provide one. Open the source-linked records below to inspect their scope and limits.
This map describes PeptideScanner’s selected, source-linked collection. It is not an evidence grade and does not establish research quality, safety, effectiveness, or medical relevance.
0 of 0 selected trial records include at least one phase value; 0 of 0 include a status value in the retained structured contract.
PubMed bibliography
Publication composition
0 of 23 selected PubMed records include attributed title, venue, publication date, and publication-type fields.
Bibliography fields unavailable here for 23 selected records; the records remain visible as metadata observations.
Regulatory and publication surfaces
What is structurally connected?
Drugs@FDA applications
0
FDA Federal Register documents
1
DailyMed SPL versions
0
Canonical profile
Published
Profile structured data
Published
Linked dated records
25
Application counts reflect exact reviewed ingredient connections; Federal Register counts reflect exact reviewed peptide-name matches; DailyMed counts reflect listed SPL versions with retained ZIP receipts. “Published” describes this page’s indexing surface, not the state of scientific evidence.
We narrowed the status wording to what the dated FDA briefing establishes. A briefing prepared for an advisory process does not establish the current absence of a later final decision. Related substance identities remain distinct.
The Federal Register published notice 2026-07361, attributed to FDA and its parent HHS department, on 2026-04-16. Its official title is “Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List,” and PeptideScanner's exact reviewed identity mapping connects the document to BPC-157, Emideltide, Epitalon, KPV, MOTS-c, Semax and TB-500.
PeptideScanner retained PubMed bibliographic metadata for PMID 11087911 at 2026-07-30T20:48:24.194Z. PubMed recorded a metadata revision date of 2019-08-31 and an Entrez history date of 2000-11-23. PeptideScanner associated this retained record with the identity slug epitalon. These dates describe PubMed metadata history, not the article's original publication date.
Counts and links describe PeptideScanner’s selected records. They are not rankings and do not establish research quality, safety, effectiveness, or medical relevance.
These links are based only on overlapping years and evidence lanes in PeptideScanner’s selected records. They do not imply that the peptides are medically or scientifically similar.
These dates come from selected source records and PubMed metadata. They are not a complete or continuous timeline of research, safety, approval, or effectiveness.
Evidence summary
What the cited records say
FDA's July 2026 briefing evaluates epitalon free base and acetate and distinguishes the tetrapeptide from epithalamin, a pineal-gland extract. The briefing is an advisory-process assessment, not a final regulatory determination.↗
This is a source summary, not a medical recommendation. Status may differ by jurisdiction and product.
FDA convened its Pharmacy Compounding Advisory Committee on July 23-24, 2026, to discuss free-base and acetate bulk drug substances across seven peptide-related groups.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 40493162 at 2026-07-30T16:14:11.014Z. PubMed recorded a metadata revision date of 2026-06-13 and an Entrez history date of 2025-06-10. PeptideScanner associated this retained record with the identity slug epitalon. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 41240216 at 2026-07-30T16:20:41.667Z. PubMed recorded a metadata revision date of 2026-05-20 and an Entrez history date of 2025-11-15. PeptideScanner associated this retained record with the identity slug epitalon. These dates describe PubMed metadata history, not the article's original publication date.↗
The Federal Register published notice 2026-07361, attributed to FDA and its parent HHS department, on 2026-04-16. Its official title is “Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List,” and PeptideScanner's exact reviewed identity mapping connects the document to BPC-157, Emideltide, Epitalon, KPV, MOTS-c, Semax and TB-500.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 12209581 at 2026-07-30T16:30:44.156Z. PubMed recorded a metadata revision date of 2026-01-28 and an Entrez history date of 2002-09-05. PeptideScanner associated this retained record with the identity slug epitalon. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 25535022 at 2026-07-30T20:43:08.960Z. PubMed recorded a metadata revision date of 2019-12-10 and an Entrez history date of 2014-12-24. PeptideScanner associated this retained record with the identity slug epitalon. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 14501183 at 2026-07-30T20:44:18.228Z. PubMed recorded a metadata revision date of 2019-11-08 and an Entrez history date of 2003-09-23. PeptideScanner associated this retained record with the identity slug epitalon. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 11087911 at 2026-07-30T20:48:24.194Z. PubMed recorded a metadata revision date of 2019-08-31 and an Entrez history date of 2000-11-23. PeptideScanner associated this retained record with the identity slug epitalon. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 12049808 at 2026-07-30T20:50:08.377Z. PubMed recorded a metadata revision date of 2019-07-20 and an Entrez history date of 2002-06-07. PeptideScanner associated this retained record with the identity slug epitalon. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 12101568 at 2026-07-30T21:22:56.967Z. PubMed recorded a metadata revision date of 2017-11-16 and an Entrez history date of 2002-07-10. PeptideScanner associated this retained record with the identity slug epitalon. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 15490730 at 2026-07-30T21:35:53.278Z. PubMed recorded a metadata revision date of 2016-10-21 and an Entrez history date of 2004-10-20. PeptideScanner associated this retained record with the identity slug epitalon. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 17152723 at 2026-07-30T21:35:54.214Z. PubMed recorded a metadata revision date of 2016-10-21 and an Entrez history date of 2006-12-13. PeptideScanner associated this retained record with the identity slug epitalon. These dates describe PubMed metadata history, not the article's original publication date.↗