Dsip: Safety Profile & Research Summary
Expert ReviewedGMP CertifiedLast Reviewed: May 2026
Preclinical Research Summary
Key Preclinical Studies
| Study | Model | Key Findings | Ref |
|---|---|---|---|
| Mu et al. (2024) | Mice — PCPA-induced insomnia | Wakefulness ↓ from 720→600 min (p<0.001); ↑ serotonin + melatonin | [1] |
| Monnier/Polc (1977–78) | Rabbits/Cats — EEG/sleep | 39–54% increase in delta activity (rabbits); enhanced REM in cats | [17] |
| Tukhovskaya et al. (2021) | SD rats — MCAO stroke, 120 µg/kg intranasal | Significant motor recovery (Rotarod p<0.01); infarct size not significantly reduced | [7] |
| Tukhovskaya et al. (2021) | SD rats — MI reperfusion, 150 µg/kg IP | IA/AAR reduced to 28.7% vs 42.1% control (p=0.01); ⚠️ 100% mortality during occlusion | [8] |
| Popovich et al. (2003) | SHR mice — 2.5 µg/mouse SC monthly | Max lifespan +24.1% (917 vs 739 d); tumors ↓2.6-fold; chromosomal aberrations ↓22.6% | [10] |
| Hrnčić et al. (2018) | Rats — lindane-induced seizures, 1 mg/kg IP | Reduced seizure intensity; prolonged seizure latency; decreased EEG ictal periods | [16] |
| Scherschlicht/Tissot (Patent) | Mice — morphine withdrawal (naloxone-precipitated) | Dose-dependent withdrawal inhibition: 0.3 mg/kg SC reduced jumping to 54% of control | [13] |
| Nakamura et al. (1988) | Mice/Rats — pain tests (tail-pinch, hot plate) | Potent dose-dependent antinociception via ICV; blocked by naloxone (opioid-mediated) | [11] |
Clinical / Human Studies
| Trial | Population | Key Results | Outcome | Ref |
|---|---|---|---|---|
| Acute Effects in Normals | n=6 healthy adults | 59% median increase in total sleep time; ↑ SWS and REM | Success | [3] |
| 7-Night Insomnia Treatment | n=14 chronic insomniacs | Normalized sleep efficiency and daytime alertness to levels of healthy controls | Success | [4] |
| Withdrawal Syndromes | n=107 (47 alcoholics, 60 opiate addicts) | Opiate: 97% improved; Alcohol: 87% improved; DTs terminated in 6/8 | Success | [2] |
| Chronic Pain Pilot | n=7 (migraine, tinnitus, psychogenic pain) | Pain reduced in 6/7 subjects; simultaneous reduction in depression | Success | [5] |
| Double-Blind Insomnia | n=16 chronic insomniacs | Effects described as "weak"; authors concluded "not likely to be of major therapeutic benefit" | Failure | [3] |
Safety Summary
| Parameter | Finding |
|---|---|
| FDA Category 2 Warning | "Significant safety risks" — potential immunogenicity; "lacks sufficient information"; not approved for compounding |
| Acute Toxicity (Animals) | Oral LD50 in rats >5,000 mg/kg; MTD in dogs >2,000 mg/kg — high safety margin |
| Historical Human Trials | Mild adverse events: headache, nausea, vertigo; described as "incredibly safe" in 70+ subjects |
| ⚠️ CRITICAL TIMING | 100% mortality when given during active ischemic occlusion (MI or stroke); protective ONLY during reperfusion |
| Pharmacokinetics | Half-life ~15 min; degraded by aminopeptidases (N-terminal Trp cleavage); crosses BBB partly |
| Drug Interactions | Antagonizes morphine; reversed by naloxone; reverses amphetamine hyperthermia; incompatible with peptidase inhibitors (captopril) |
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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“Preclinical Research Summary Key Preclinical Studies StudyModelKey FindingsRef Mu et al.”
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