Epithalon: Safety Profile & Research Summary
Expert ReviewedGMP CertifiedLast Reviewed: February 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 patients | 5.0 µg parabulbar daily × 10 days | 90% positive effect; visual acuity +0.15–0.20; visual field expanded 90–120° in 64.8% | [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 | Patients 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 patients | 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 |
Related Research Questions
Want the complete research review?
View Full Epithalon Research Page→FOR RESEARCH USE ONLY
This content is provided for educational and informational purposes only. Products are furnished for in-vitro studies only and are not medicines, drugs, or supplements. Not approved by the FDA to prevent, treat, or cure any condition.