Epithalon: Safety Profile & Research Summary
Expert ReviewedGMP CertifiedLast Reviewed: April 2026
Preclinical Research Summary
Key Preclinical Studies
| Study | Model | Key Findings | Ref |
|---|---|---|---|
| Anisimov/Popovich et al. (2003) | SHR mice — 1 µg/mouse SC × 5d/month from 3 mo | Last 10% lifespan increased 13.3%; chromosomal aberrations ↓17.1%; leukemia inhibited 6-fold | [7] |
| Anisimov et al. (2002) | HER-2/neu transgenic mice — 1 µg/mouse SC monthly | HER-2/neu mRNA reduced 3.7-fold; breast adenocarcinoma incidence significantly reduced | [14] |
| Kossoy et al. (2006) | C3H/He mice — 0.1 µg/mouse SC × 5x/wk × 6.5 mo | Reduced tumor metastasis and multiplicity | [8] |
| Anisimov et al. (2001) | CBA mice — 0.1 µg/mouse SC monthly | Oldest treated mouse lived 34 months vs 24 mo control; mice reaching 23 mo increased 4-fold | [8] |
| Khavinson et al. (2002–03) | Campbell rats — 1 µg/rat parabulbar injection | Retinal function prolonged 43.9%; 90% of retinal layers preserved at day 41 vs complete destruction | [9] |
| Zamorskii et al. (2014–19) | Rats with acute kidney failure — 7 µg/kg IM/IP × 7–10d | Nephroprotective — increased diuresis, decreased proteinuria, ↑ catalase and glutathione peroxidase | [13] |
| Goncharova et al. (2001–05) | Old female rhesus monkeys — 10 µg/kg IM | Restored nighttime melatonin synthesis; normalized cortisol circadian rhythm; improved glucose tolerance | [11] |
| Khavinson et al. (2000–01) | Drosophila — 0.00001–0.001% in medium | Mean lifespan +11–16%, max +14%; mortality ↓52%; SOD +41%, catalase +20% | [6] |
| Ullah et al. (2025) | Bovine oocytes in vitro | Activated telomerase; improved blastocyst hatching; reduced ROS | [10] |
Clinical / Human Studies
| Trial | Population | Intervention | Key Results | Ref |
|---|---|---|---|---|
| Retinitis Pigmentosa | n=162 subjects | 5.0 µg parabulbar daily × 10 days | Reported positive observations; visual acuity and visual field improvements noted in study | [9] |
| Circadian Rhythm | n=75 women, age 60–74 | 0.5 mg sublingual daily × 20 days | Melatonin +1.6-fold; Clock ↓1.8×, Cry2 ↑2×, Csnk1e ↓2.1× | [15] |
| Telomere Elongation | Subjects aged 60–80 | Standard protocol | Ages 60–65: 9.61→10.72 kb; Ages 75–80: 7.51→8.91 kb (both p<0.05) | [5] |
| Pulmonary Tuberculosis | TB subjects | Not specified | Protective effect against further chromosomal aberrations (mixed outcome) | [16] |
Safety Summary
| Parameter | Finding |
|---|---|
| Long-term Animal Studies | No toxicity in mice/rats from 3 months of age until natural death; reduced mortality and spontaneous tumors |
| Clinical Trials | No severe adverse events in retinitis pigmentosa (n=162) or circadian rhythm trials; mild injection site reactions reported anecdotally |
| Cancer Risk Paradox | Despite telomerase activation, animal studies consistently show ANTI-tumor and anti-metastatic effects |
| Degradation | N-terminal glutamic acid can cyclize to pyroglutamate; TFA salt affects net peptide content |
| Routes Studied | Subcutaneous, intramuscular, parabulbar (eye), sublingual, oral, intranasal |
In Vitro / Preclinical Disclaimer: The research findings described above were observed in laboratory (in vitro) and/or animal model studies. These results may not translate to human outcomes. No claims are made regarding human therapeutic applications.
Educational Use Only: This content is provided for informational and educational purposes only. It is not intended as medical advice and should not be used to diagnose, treat, cure, or prevent any disease or medical condition. Always consult qualified healthcare professionals for medical decisions.
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