Tempol is a small-molecule cell-permeable superoxide dismutase (SOD) mimetic that is able to act as SOD1, SOD2, SOD3 and catalase in vivo. [NOT to be confused with the “Tempol” brand of paracematol, also known as acetaminophen, an over-the-counter analgesic that is a generic form of Tylenol®]
|It attenuates superoxide anion and peroxynitrite-induced inflammation, lowers blood peressure in a variety of models and displays neuroprotective effects. It restores mitochondrial and cardiac functions in TNFα-induced oxidative stress and reduces cardiac hypertrophy in chronic hypoxic rats.|
In “Effects of tempol and redox-cycling nitroxides in models of oxidative stress”, Christopher S. Wilcox, M.D., Ph.D. explains:
“Tempol is a redox cycling nitroxide that promotes the metabolism of many reactive oxygen species (ROS) and improves nitric oxide bioavailability.
It has been studied extensively in animal models of oxidative stress.
Tempol has been shown to preserve mitochondria against oxidative damage and improve tissue oxygenation.
Tempol improved insulin responsiveness in models of diabetes mellitus and improved the dyslipidemia, reduced the weight gain and prevented diastolic dysfunction and heart failure in fat-fed models of the metabolic syndrome.
Tempol protected many organs, including the heart and brain, from ischemia/reperfusion damage.
Tempol prevented podocyte damage, glomerulosclerosis, proteinuria and progressive loss of renal function in models of salt and mineralocorticosteroid excess. It reduced brain or spinal cord damage after ischemia or trauma and exerted a spinal analgesic action.
Tempol improved survival in several models of shock. It protected normal cells from radiation while maintaining radiation sensitivity of tumor cells. Its paradoxical pro-oxidant action in tumor cells accounted for a reduction in spontaneous tumor formation.
Tempol was effective in some models of neurodegeneration.
Thus, tempol has been effective in preventing several of the adverse consequences of oxidative stress and inflammation that underlie radiation damage and many of the diseases associated with aging.
Indeed, tempol given from birth prolonged the life span of normal mice.”
Sucessful treatment of fibrocystic disease or breast with Tempol is detailed by Dr. Peter Proctor in “Nitrone, Nitroso, And Nitroxide Spintraps And Spin Labels And Their Hydroxylamines”, US Patent 2012/0115905 A1 issued May 10, 2012:
“One-half ml of the above solution, comprising 10 mg TEMPOL plus 100 mg ascorbic acid, was administered orally once a day to a 50 kg woman with a long history for fibrocystic disease of breast so severe that surgeons had recommended mastectomy. The same person had also been previously diagnosed with severe trigeminal neuralgia.
First results appeared after 1-2 weeks of treatment and involve shrinkage of the breast cysts, as verified by before and after mammographic imaging, and digital palpation. Long-term relief can be achieved, but the symptoms eventually reappear on cessation of treatment for a few weeks. Upon resumption of treatment, symptoms the breast cysts again drastically shrink. The patient had also suffered from long standing trigeminal neuralgia which was also alleviated and prevented.
Alternate forms of oral administration such as tablets, pills or capsules are also effective. Parental modes of administration such as intravenous, intramuscular, subcutaneous, intraperitoneal, transrectal and so forth are also possible, as are topical modes of administration such as in lotions, creams, gels, and topically-compatible suspensions and solutions.”
The patent gives further information on Tempol dosing and clinical use with ranges between 10 mg and 100 mg depending on the condition and level of oxidative stress. It claims protection on a wide dosing range “where the pharmacologically active dose is 0.01-1000 mg per day of a pharmacologically active nitroxide, nitrone, or nitroso spin-trap, spin label or their equivalent hydroxylamine and other reduced derivatives administered by suitable means such as orally, sublingually, transrectally, intramuscularly, intravenously, or subcutaneously.”
This wider patent-protected range is still lower than human doses claimed in other patents where dosing is based on extrapolations from animal studies, not clinical trials or experience with human subjects. The Proctor patent states the lower human dose “may be an unexpected consequence of the presence in humans and higher primates of singularly high levels of the powerful reducing substance uric acid.”
Tempol is currently not available as a prescription.
Since it has no composition of material patent protection, it is doubtful a pharmaceutical company will bear the expense of the large clinical trials necessary for FDA approval of Tempol.
However, a medical doctor may prescribe unlicensed or off-label medications as noted in the Proctor patent above.
With any off-label or unlicensed medicine, it is up to the prescribing physician to make the clinical assessment, take responsibility for prescribing the medication and for overseeing the patient’s care, including monitoring, documenting and any follow-up treatment.
Tempol is available for research purposes and is a promising treatment for anti-aging and disorders related to oxidative stress.
Tempol may well be the most important therapeutic breakthrough in over fifty years. It holds promise to substantially reduce health care costs and improve treatment of a wide array of diseases.