The first human tests of TOP-M119 are about to begin in China, an experimental drug that will revolutionize treatments against baldness. It is based on the active ingredient of Viagra and nitroglycerin. How it works and why researchers are very confident.
The Swiss biopharmaceutical house Topadur Pharma has developed a experimental drug against the hair loss that promises effectiveness And safety significantly higher than those of treatments already on the market. One of the most interesting aspects of the drug candidate, currently known by the code name of TOP-M119lies in the fact that it is based on the sildenafil citratethe active ingredient of Viagra – the best known drug against erectile dysfunction – and the nitroglycerin. This explosive chemical compound is known to most for its remarkable reactivity to heat and shock, as evidenced by multiple Hollywood action blockbusters, but it is also a cardiovascular drug; it is for example used againstangina pectoris (chest pain) thanks to the action vasodilatory. Viagra also promotes blood flow and in addition to the treatment of erectile dysfunction it can also be a valuable aid against it heart failure.
Since in androgenetic alopecia – the main cause of hair loss in the world in men and women – the poor supply of blood and oxygen plays an important role in making the hairs non-functional hair follicles, researchers at Topadur Pharma decided to test the two chemical compounds in combination to promote hair growth. As stated by Dr. Reto Naef, CEO of the Swiss biopharmaceutical company, this combination can increase 1,000 times there blood circulation in the scalp. The results of the preclinical studies on the individual compounds included in TOP-M119, moreover, were extremely significant; for example, Viagra has been shown to improve the phase anagen (active) in the hair growth of rodents. Another model study highlighted that the active ingredients of the candidate drug are able to protect against hair loss triggered by ccyclophosphamidea drug used in chemotherapy. TOP-M119 works by stimulating the cGMP enzymatic regulatory system (cyclic guanosine monophosphate), whose higher levels promote blood circulation and with it hair growth.
At the moment no clinical studies have been conducted, i.e. on humans, however, Topadur Pharma has just signed an agreement with the Chinese investment fund Oshen Holdings SA not only to develop the liquid formulation of the drug, but also to prepare the first clinical trials and market the drug in China once authorized. Moreover, it is believed that the market for drugs against baldness can reach i 16 billion dollars by 2030, so it is not surprising that large investment funds are also moving to support research. “Based on our preclinical data, we believe that TOP-M119 can become a game-changer in treating hair loss and improving hair quality. The partnership agreement with Oshen allows us to accelerate the development of TOP-M119 and provide faster access to patients,” Dr. Pascal Brenneisen of Topadur Pharma AG said in a press release.
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One of the reasons why there is a need for new drugs against baldness lies in the fact that the most used oral treatment – finasteride – can have significant side effects such as sexual dysfunction and depression, while another topical drug called minoxidil “demonstrates unsatisfactory efficacy”, was highlighted in the study “Dual-Mode Vasodilator M119 Delivery to Hair Follicle via Dissolving Microneedle for Advanced Alopecia Treatment”. The new drug candidate is administered to the scalp through microneedles which dissolve in the skin (dissolving microneedle – DMN) allowing transdermal release. It is a minimally invasive method that does not cause particular discomfort to patients and catalyzes the action of the active ingredients. All that remains is to wait for the results of the first clinical studies to be certain of the effectiveness and safety of TOP-M119 also in humans.
