Epitalon
Synthetic tetrapeptide (Ala-Glu-Asp-Gly / AGED) derived from the bovine pineal gland peptide extract Epithalamin. Developed by Prof. Vladimir Khavinson at the St. Petersburg Institute of Bioregulation and Gerontology. Investigated in Russian gerontology for telomerase activation, pineal melatonin rhythm restoration, and longevity. Lacks FDA, EMA, or EDA approval; WADA S0 prohibited.
60-Second Scientific Briefing
Epitalon (Epithalon) is a synthetic tetrapeptide (Ala-Glu-Asp-Gly) modeled after the natural bovine pineal extract epithalamin. Studied in cell culture and animal models for telomerase activation, telomere elongation, and lifespan extension. It is NOT approved by the US FDA, EMA, or Egyptian authorities.
What is Epitalon?
Pharmacological Classification & Molecular IdentitySynthetic tetrapeptide (Ala-Glu-Asp-Gly) synthesized as the active fraction of bovine pineal gland peptide extract.
Verified Chemical & Regulatory Registry Identifiers
Mechanism of Action & Receptor Targets
Biological Pathway and Target BindingBiological pathway and target receptor binding mechanism.
Receptor Selectivity: Interacts with DNA histone proteins and chromatin to activate the human telomerase reverse transcriptase (hTERT) gene, promoting telomere elongation in somatic cells.
Regulatory & FDA Approval Status
Legal and Regulatory ClassificationsNot approved by the US FDA or EMA for anti-aging, longevity, or any disease. Research chemical only.
Epitalon is not approved for commercial sale, prescription therapy, or compounded medication distribution. It exists strictly within authorized scientific and clinical research frameworks.
Human Evidence & Clinical Trials
Clinical Study Readouts and Evidence SynthesesDocumented in in vitro human somatic cell models and regional observational studies in St. Petersburg; lacks international double-blind randomized clinical trial verification.
Clinical Evidence
Documented in in vitro human somatic cell models and regional observational studies in St. Petersburg; lacks international double-blind randomized clinical trial verification.
Safety Profile & Clinical Limitations
Documented Adverse Events and Known UncertaintiesSystematic human safety profiles and clinical adverse event incidence are not established under FDA/EMA guidelines.
Theoretical oncogenic risks associated with uncontrolled telomerase activation in pre-malignant cell lines.
Dose Approval Status
Commercial Dosing Status and Policy DirectivesNOT ESTABLISHED. No approved human dose or clinical guideline exists.
Under Egypt Peptides medical governance policies, no personal dosages, titration intervals, cycles, stacking recommendations, or self-injection instructions may be provided for unapproved investigational compounds. Clinical study protocols represent controlled experimental research parameters exclusively.
What is Known vs. What is Unknown
Evidence Comparison and Clinical Evidence Boundaries✓ Confirmed Scientific Evidence
- Synthetic tetrapeptide (Ala-Glu-Asp-Gly) synthesized as the active fraction of bovine pineal gland peptide extract.
- Targets & Selectivity: Interacts with DNA histone proteins and chromatin to activate the human telomerase reverse transcriptase (hTERT) gene, promoting telomere elongation in somatic cells.
- Documented in in vitro human somatic cell models and regional observational studies in St. Petersburg; lacks international double-blind randomized clinical trial verification.
- Safety considerations: Systematic human safety profiles and clinical adverse event incidence are not established under FDA/EMA guidelines.
? Unknown / Under Ongoing Investigation
- Theoretical oncogenic risks associated with uncontrolled telomerase activation in pre-malignant cell lines.
Verified Questions & Answers
10 Verified scientific answers with permanent anchor keysEpitalon is classified as a Synthetic Peptide Bioregulator. Molecular structure: Synthetic tetrapeptide (Ala-Glu-Asp-Gly) synthesized as the active fraction of bovine pineal gland peptide extract..
Pharmacological classification and molecular integrity are documented in verified regulatory and scientific literature.
- Epithalon peptide induces telomerase activity and telomere elongation in human somatic cells (Bulletin of Experimental Biology and Medicine, 2003-06-01)
Epitalon exerts biological activity via Interacts with DNA histone proteins and chromatin to activate the human telomerase reverse transcriptase (hTERT) gene, promoting telomere elongation in somatic cells..
Receptor binding affinity and selectivity dictate the physiological response observed in laboratory and clinical trials.
- Epithalon peptide induces telomerase activity and telomere elongation in human somatic cells (Bulletin of Experimental Biology and Medicine, 2003-06-01)
Regulatory status: Not approved by the US FDA or EMA for anti-aging, longevity, or any disease. Research chemical only.
Investigational and research-only compounds cannot be legally distributed or marketed as prescription drugs.
- FDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) (U.S. Food and Drug Administration, 2023-09-29)
- Epithalon peptide induces telomerase activity and telomere elongation in human somatic cells (Bulletin of Experimental Biology and Medicine, 2003-06-01)
Clinical evaluation status: Documented in in vitro human somatic cell models and regional observational studies in St. Petersburg; lacks international double-blind randomized clinical trial verification.
Clinical trial readouts and systematic analyses establish the boundary between demonstrated findings and experimental hypotheses.
- Epithalon peptide induces telomerase activity and telomere elongation in human somatic cells (Bulletin of Experimental Biology and Medicine, 2003-06-01)
Reported safety profile: Systematic human safety profiles and clinical adverse event incidence are not established under FDA/EMA guidelines.
Adverse reaction monitoring and contraindications are critical parameters in pharmacological risk-benefit evaluation.
- Epithalon peptide induces telomerase activity and telomere elongation in human somatic cells (Bulletin of Experimental Biology and Medicine, 2003-06-01)
Key scientific uncertainties: Theoretical oncogenic risks associated with uncontrolled telomerase activation in pre-malignant cell lines.
Egypt Peptides enforces strict transparency regarding scientific limitations and gaps in longitudinal clinical data.
- FDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) (U.S. Food and Drug Administration, 2023-09-29)
NOT ESTABLISHED. No approved human dose or clinical guideline exists.
Under medical governance mandates, clinical study dosages represent strictly controlled experimental parameters and must never be interpreted as individual therapeutic advice.
- FDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) (U.S. Food and Drug Administration, 2023-09-29)
Storage status: NOT ESTABLISHED for pharmaceutical use. Laboratory storage requires -20°C.
Peptide integrity degrades rapidly when exposed to elevated temperatures, repeated freeze-thaw cycles, or direct UV light exposure.
- FDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) (U.S. Food and Drug Administration, 2023-09-29)
Yes. Unapproved pharmacological substances are strictly prohibited at all times in competitive sports under WADA Category S0 (Non-approved substances) or Category S2.
Athletes subject to drug testing face strict liability and multi-year competition bans upon detection of prohibited peptides or their metabolites.
- FDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) (U.S. Food and Drug Administration, 2023-09-29)
- Epithalon peptide induces telomerase activity and telomere elongation in human somatic cells (Bulletin of Experimental Biology and Medicine, 2003-06-01)
Egypt Peptides provides peer-reviewed scientific reference monographs for research documentation. We strictly prohibit individual medical consultations, reconstitution guides, stacking recipes, or off-label use instructions.
All scientific claims must link to verified authoritative sources (FDA, PubMed, ClinicalTrials.gov) with zero tolerance for ungrounded marketing claims.
- Epithalon peptide induces telomerase activity and telomere elongation in human somatic cells (Bulletin of Experimental Biology and Medicine, 2003-06-01)
Authoritative Sources & Literature Registry
Regulatory dossiers, clinical trial registries, and peer-reviewed studiesFDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) ↗
https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
Epithalon peptide induces telomerase activity and telomere elongation in human somatic cells ↗
https://doi.org/10.1023/a:1025493705728