Bottom line
A boundary-case combination pairing Epitalon (a synthetic tetrapeptide, Ala-Glu-Asp-Gly, based on pineal gland peptides) with Thymalin (a bovine thymus polypeptide extract, not a single defined peptide). No direct human study of this named Epitalon + Thymalin combination was identified. The human mortality paper often cited for it tested Epithalamin, an animal-derived pineal polypeptide extract, with Thymalin; it did not test synthetic Epitalon. That distinction prevents the paper from establishing efficacy for the blend named on this page.
No established or recommended human dose.
Name and formulation variability
| Context | Material actually studied | Marketed label | Verification limits |
|---|---|---|---|
| Khavinson and Morozov human report (2003) | Thymalin plus Epithalamin, both polypeptide complexes; study-specific exposure | Not an Epitalon product | It was not Epitalon and was not a co-formulated product |
| Online-market observations | No standardized study material | “Epitalon + Thymalin”; variable declarations | No external formulation or quality standard identified |
Thymalin is a polypeptide extract (not a single peptide) with batch-to-batch variability inherent to animal-derived biological products. Epitalon is a well-defined synthetic tetrapeptide.
Also known as: Thymalin + Epitalon, pineal-thymus peptide therapy, AEDG + thymus polypeptides.
The 2003 human report concerned Thymalin plus Epithalamin. The marketed label concerns Epitalon plus Thymalin. Epithalamin and Epitalon are not interchangeable; Thymalin is a polypeptide mixture, while Epitalon is a defined tetrapeptide. The report cannot be relabeled as the market pair.
Component evidence
| Component | Identity type | Separate evidence | Compatibility/stability evidence |
|---|---|---|---|
| Epitalon (Ala-Glu-Asp-Gly) | Defined synthetic tetrapeptide | Evidence from in vitro or animal studies with no adequate human efficacy evidence — the atlas Grade D lane. 定义来源: Evidence grading methodology · 术语表 gerontology and cell studies are reviewed in the separate monograph | Not identified |
| Thymalin | Animal-derived polypeptide mixture, not one defined sequence | A later review from the same group reports historical Soviet medical-use authorization; the 2003 report studied Thymalin with Epithalamin | Animal-derived extract and batch variability; reported process controls are not independent product-quality verification |
Shared combination-evidence caption: no evidence for a standardized Epitalon plus Thymalin co-formulation was identified. The 2003 report used Epithalamin, not Epitalon.
Combination-specific studies
Khavinson and Morozov (2003; PMID 14523363) reported two clinical cohorts totaling 266 older participants at centers in St. Petersburg and Kyiv. The frequently repeated combination figures came from the St. Petersburg mortality table, not from all 266 participants. In that table, the control group was 22 people, the Thymalin + Epithalamin group treated in the first two years was 24 people, and a separate annual-treatment group was 20 people. Six-year mortality was reported as 81.8%, 33.3%, and 20.0%, respectively, which the authors described as 2.5-fold and 4.1-fold reductions relative to control. The paper describes stratified randomization, An inactive comparator used in a controlled study. 定义来源: Neutral gloss; usage context: Evidence grading methodology · 术语表 control, and double blinding for the 94-woman four-group trial, but describes the 20-person annual-treatment cohort separately and does not say that this cohort was randomized.
These are source-reported, small-group results from an older study without a prospective trial registration or an independently replicated mortality trial. The report does not provide enough detail to resolve allocation concealment, attrition, or the comparability of the separate annual-treatment cohort. Most importantly for this page, both quantitative comparisons concern Thymalin + Epithalamin, not synthetic Epitalon + Thymalin. They therefore cannot be treated as efficacy evidence for the marketed blend named here.
Safety and interaction uncertainties
Thymalin is a bovine extract with potential batch-to-batch variability and theoretical adventitious-agent risk; the 2003 authors reported negative tests after extraction and purification, but no independent lot-level evidence was identified
No standardized use or independent product specification outside the cited historical practice was identified
No published drug-interaction data
No independent replication of the clinical findings by non-affiliated groups
Regulatory and product-quality notes
Thymalin: a later review by the same research group reports Soviet medical-use authorization under Order No. 1108 of November 10, 1982; this atlas did not independently retrieve that historical regulator record
Epitalon: synthesised at St. Petersburg Institute of Bioregulation and Gerontology; patented 2000
Neither is FDA-approved, and no centrally authorized EMA product was identified
Online sellers use “research use only” labels; that wording is not authorization for human use
The World Anti-Doping Agency; its Prohibited List classifies many peptides as prohibited substances in sport. 定义来源: WADA and sport regulation brief · 术语表: neither marketed name is explicitly listed in the 2026 index. WADA Prohibited List class S0 (non-approved substances): pharmacological substances not addressed elsewhere in the list and with no current approval by any governmental regulatory health authority for human therapeutic use. 定义来源: WADA and sport regulation brief · 术语表 is a catch-all for non-approved pharmacological substances not otherwise addressed; athletes need a case-specific anti-doping determination.
Evidence gaps
No direct human trial or independent replication for Epitalon + Thymalin
The mortality study used Epithalamin (pineal extract), not synthetic Epitalon, and its often-quoted combination groups were much smaller than the 266-person total
Thymalin composition is not a single defined peptide
No How a substance is absorbed, distributed, metabolized, and eliminated by the body; atlas pages report pharmacokinetic data such as half-life, metabolism, and clearance. 定义来源: Neutral gloss; usage context: Routes, devices, and absorption primer · 术语表 data for the combination
No regulatory review outside Russia
Single research group produced the majority of published literature
See the identity methodology for mixture boundary cases and the blend index for why market names must not substitute for exact material identity.
Sources
Khavinson VKh, Morozov VG. Peptides of pineal gland and thymus prolong human life. Neuro Endocrinol Lett. 2003;24(3-4):233-240. PMID 14523363. https://pubmed.ncbi.nlm.nih.gov/14523363/ Full paper scan: https://khavinson.info/assets/files/skan/2003-khavinson_morozov1.pdf accessed 2026-08-06.
MDPI Int J Mol Sci. 2025;26(6):2691. Epitalon review. https://www.mdpi.com/1422-0067/26/6/2691 accessed 2026-08-06.
Anisimov VN, Khavinson VKh, Mikhalski AI, Yashin AI. Effect of synthetic thymic and pineal peptides on biomarkers of ageing, survival and spontaneous tumour incidence in female CBA mice. Mech Ageing Dev. 2001;122(1):41-68. PMID 11163623. https://pubmed.ncbi.nlm.nih.gov/11163623/
Khavinson VKh, Kuznik BI, Ryzhak GA. Peptide bioregulators: a new class of geroprotectors. Report 2. The results of clinical trials. Adv Gerontol. 2014;4(4):346-361. DOI 10.1134/S2079057014040122. https://khavinson.info/assets/files/2014-Khavinson_Kuznik.pdf
World Anti-Doping Agency. 2026 Prohibited List. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf