Research information only, not medical advice. Research peptide, not approved for human use anywhere. Up for an FDA advisory committee vote on July 24, 2026 (evaluated indication: Insomnia). Removed from the FDA 'do not compound' list in April 2026 but not yet compoundable.
Epitalon at a glance
As of June 2026 the human evidence is limited; most data is preclinical. See the indexed studies below, graded by evidence level.
All seven peptides on the agenda are covered in the July 2026 FDA peptide meeting.
Evidence profile
88 studies- Human trial 8 · 9%
- Review 30 · 34%
- Animal 20 · 23%
- In-vitro 24 · 27%
- Unknown 6 · 7%
The longer the green, the stronger the human evidence. For most research peptides the bar is dominated by animal and in-vitro work, which is a signal to read every claim carefully.
Regulatory status
- 2026-04-22 US-FDA
Removed from the FDA 503A 'do not compound' Category 2 (nominations withdrawn) — still not eligible for compounding. source
- 2026-07-24 US-FDA · upcoming
FDA Pharmacy Compounding Advisory Committee vote (evaluated indication: Insomnia); docket FDA-2025-N-6895. source
Indexed research
Sorted by evidence level, strongest first.
- Human trial 2017[Pineamin increased pineal melatonin synthesis in elderly people]
This study found that Pineamin increased nighttime urinary 6-sulfatoxymelatonin excretion by 1.9 times in 55 elderly patients with reduced melatonin synthesis.
- Human trial 2013[Genome instability in pulmonary tuberculosis before and after treatment]
This study evaluates genome instability in pulmonary tuberculosis patients before and after treatment, including the effect of the anti-stress peptide epitalon.
- Human trial 2024Improving Biological Age, Telomere Length, and Cognition: A Case Report on the Use of Therapeutic Plasma Exchange, Peptides, Umbilical Cord Tissue Mesenchymal Stem Cells and Exosomes in a Patient with Cognitive Decline
This case report describes a 79-year-old male with cognitive decline who received a combination of therapeutic plasma exchange, peptides, and stem cell therapy, resulting in reduced biological age, increased telomere length, and improved cognition.
- Human trial 2013THE CORRECTION OF MELATONIN-PRODUCING FUNCTION VIOLATIONS OF PINEAL GLAND IN ELDERLY PEOPLE WITH SUBSTITUTIVE DOSES OF MELATONIN AND EPIPHYSIS PEPTIDE DRUGS
This study examines the effects of different melatonin doses and epiphysis peptide drugs on correcting age-related melatonin production in elderly people.
- Human trial 2013[Genome instability in pulmonary tuberculosis before and after treatment].
This study evaluates genome instability in pulmonary tuberculosis patients before and after treatment, including the effect of the peptide epitalon.
- Human trial 2008[The effect of heavy metal ions and peptide bioregulators on the expression of chromosome fragile sites in the individuals of different age groups and breast cancer patients].
This study examines the effect of heavy metal ions and peptide bioregulators on chromosome fragile site expression in different age groups and breast cancer patients.
- Human trial 2017[Pineamin increased pineal melatonin synthesis in elderly people].
This study found that Pineamin increased nighttime urinary 6-sulfatoxymelatonin excretion in elderly patients with diminished melatonin synthesis.
- Human trial 2011Peptide Geroprotector from the Pituitary Gland Inhibits Rapid Aging of Elderly People: Results of 15-Year Follow-Up
This study reports on a 15-year follow-up of elderly people treated with a pituitary gland peptide geroprotector to inhibit rapid aging.
- Review 2026Therapeutic peptides in gerontology: mechanisms and applications for healthy aging
- Review 2026Therapeutic Peptides in Orthopaedics: Applications, Challenges, and Future Directions
+ 78 more studies indexed for Epitalon.
Frequently asked questions
- Is Epitalon approved for human use?
- Research peptide, not approved for human use anywhere. Up for an FDA advisory committee vote on July 24, 2026 (evaluated indication: Insomnia). Removed from the FDA 'do not compound' list in April 2026 but not yet compoundable.
- What does the research on Epitalon show?
- As of June 2026 the human evidence is limited; most data is preclinical. See the indexed studies below, graded by evidence level.