At a glance
- Epitalon is not an FDA-approved drug: Drugs@FDA has no record of it.
- It was on FDA's Category 2 safety-risk list until the nomination was withdrawn. A withdrawal is not an approval.
- PubMed lists 116 publications mentioning it, including 0 randomized controlled trials and 75 animal-only studies.
- ClinicalTrials.gov lists 1 registered study testing it (1 active).
- FDA’s adverse event system (FAERS) has no reports mentioning it.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
No application found in Drugs@FDA, FDA's database of approved drugs.
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
FDA's stated risk · Original FDA text (English) Compounded drugs containing epitalon may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation and peptide-related impurities. FDA has not identified safety-related information regarding epitalon for the proposed route of administration. Therefore, the agency lacks sufficient information to know whether the drug would cause harm if administered to humans. Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Epitalon and Epithalamin: A Narrative Review of Mechanistic, Preclinical, and Clinical Evidence.
- Synthetic Peptides in Pharmacy Compounding: Analysis of PCAC Recommendations and Industry Safety Standards.
- LCP2 mediates SUV39H1-driven cellular senescence-related chemoresistance in natural killer/T-cell lymphoma.
- Therapeutic peptides in gerontology: mechanisms and applications for healthy aging.
- Therapeutic Peptides in Orthopaedics: Applications, Challenges, and Future Directions.
- Correction: Epitalon increases telomere length in human cell lines through telomerase upregulation or ALT activity.
- Epitalon increases telomere length in human cell lines through telomerase upregulation or ALT activity.
- The Antioxidant Tetrapeptide Epitalon Enhances Delayed Wound Healing in an in Vitro Model of Diabetic Retinopathy.
- Overview of Epitalon-Highly Bioactive Pineal Tetrapeptide with Promising Properties.
- Epitalon-activated telomerase enhance bovine oocyte maturation rate and post-thawed embryo development.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 1
- Active
- 1
- With posted results
- 0
Conditions studied
| Study | Status | Phase | Start |
|---|---|---|---|
| Systemic and Topical Geroprotective Rejuvenation Assessed by START/REST Aging Clocks | Enrolling by invitation | Early phase 1 | October 21, 2026 |
All 1 study on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
No FAERS reports mention this peptide.
Change history
No changes since monitoring began on October 30, 2026.