Why this matters
A Product-Specific Human Study
Unlike research referring only to the AEDG peptide in general, this published randomized, placebo-controlled human study specifically identified Nanopep EPITALON® Solution-Spray as the product administered in the active study group.
The study enrolled 75 women aged 40–50. Thirty-five participants with age-appropriate 6-SMT levels served as a reference group, while 40 participants with reduced 6-SMT entered the active/placebo comparison.
The active group received Nanopep EPITALON® Solution-Spray sublingually for 20 days at a daily dose of 0.5 mg AEDG.
Excerpt from page 26 of the 2026 FDA briefing document. The historical publication identifies the product as “Epitalon Solution-Spray Nanopep, France.
VIEW FDA SOURCE — PAGE 26 ↗
READ THE PUBLISHED HUMAN STUDY ↗
2026 PCAC Vote on Epitalon
On July 24, 2026, FDA’s independent Pharmacy Compounding Advisory Committee voted 7–4–1 in favor of including Epitalon free base and 7–4–1 in favor of including Epitalon acetate on the Section 503A Bulks List.
The committee’s recommendation is advisory and does not constitute final FDA action.
This pharmacy-compounding review is separate from the published human study using Nanopep EPITALON® Solution-Spray described above.
About the Author
Kimberly Wilkes, BSc
Kimberly Wilkes, BSc has 26 years’ experience as a health and science writer. She has written extensively for functional medicine and integrative doctors and dietary supplement companies on topics such as healthy aging, the latest science supporting the use of nutraceuticals, and nitric oxide’s role in health.