Frequently Asked Questions

Betulin, the active ingredient of BETULEX™, belongs to the class of natural compounds called triterpenes which are found in a great variety of fruits, vegetables and medicinal plants and are therefore part of the human diet. Betulin has a long history of medicinal use, as several cultures all around the world have used the bark and sap of the birch tree in teas and other concoctions for kidney and bladder health, and for their anti-inflammatory and antimicrobial properties (1, 2). Betulinic acid is also present in a historically widely consumed mushroom called chaga, which grows on birch trees (3) But the most stringent evaluation of betulin’s safety came from animal studies that specifically addressed potential toxicity of betulin by administering increasing amounts, at doses up to 16 g/kg, of the pure compound into mice. Even at the highest dose studied - which is 10,000 times higher than what is provided in a single BETULEX™ capsule – scientists were unable to detect any signs of toxicity externally or in any internal organs (4, 5). These data places betulin squarely into the safest, “non-toxic” class according to any international scale of toxicity of chemical agents (6). Special study of betulin at the genetic level determined no mutagenic effects of the compound (7). In some countries, betulin has been approved for use in food industry, specifically as a natural preservative in meat products to prolong shelf life (7, 8, 4). Overall, it can be confidently concluded that betulin is a safe compound.

Our families and friends have been taking BETULEX™ for almost two years on a daily basis before we launched this product here. One obvious observation common to everybody, has been that we didn’t get sick during usual flu or cold season when a lot of people around are getting infected. Or, if somebody did get some cold, the symptoms would be not nearly as bad as usual, and they would not last as long as usual (2 days instead of usual 5). For other conditions such as metabolic or liver issues, effects of BETULEX™ would be hidden beneath the surface. Taking BETULEX™ should be considered an investment in the long-term health and rebalancing of your metabolism, and you may not feel obvious difference despite the significant improvements happening inside your body. Also, keep in mind that everyone’s physiology is unique, and results vary from person to person. The best way to see results is to track the levels of lipids and cholesterol in your blood.

Betulin’s main biological target inside the cell is a protein called SREBP (Sterol Regulatory Element Binding Protein) (9). This protein happens to be one of the key controllers of the cholesterol and lipid (fat) biosynthesis (10). Betulin’s binding to SREBP leads to reduced amounts of cholesterol and fat being generated in the cell, much like the effect of statin drugs that are being prescribed to millions of people with high cholesterol levels. In addition to multiple metabolic benefits (more details are in this blog article – LINK), reduced levels of lipids (fats) in the cell bring about protective effects against enveloped viruses which need lipids to build their outer shell (learn more in this blog article – LINK – and video – LINK). Many common viruses are enveloped (flu, coronavirus, HIV, herpes, hepatitis B and C).

Betulin has a fully elucidated mechanism of action that can explain its antiviral activity. Other natural compounds that are considered antiviral, often do not have known mechanisms of action and rely on boosting the body’s immune response to kill the virus. These natural compounds, such as garlic and astragalus have an extremely broad array of actions inside the body, some of which aid in inhibiting the virus and increasing immune support, others completely non-related to viral infection (11, 12, 13). Betulin is also multifaceted in its activity, but this is mostly caused by a single mechanism, which is the inhibition of the SREBP protein (9). This property deprives viruses of a vital component of their structure, causing them to stop proliferating, and could therefore be universal to all viruses that require a lipid envelope. This cannot be said about other agents such as echinacea and elderberry, which contain a great variety of many different compounds, all of which have different properties relating to mostly individual virus types, such as only influenza or rhinovirus (14, 15, 16, 17). The problem of targeting specific types of viruses, which is what most natural products and antiviral drugs present, is that viruses can become immune to this specific mechanism, causing the molecule to no longer be functional against that virus (18). A more general antiviral (such as betulin) is advantageous because it inhibits the proliferation of the virus regardless of its mutation status, causing it to be able to be used against more than one kind of infection.

Betulin has a broad range of biological as well as pharmacological properties that are recognized by the scientific community (19, 20, 21). Along with betulinic acid, it has been tested against many cancer types, showing activity against prostate, ovarian, breast, and lung cancer (22, 23), among others, as well as neuroblastoma, gliablastoma, and leukemia (24), all via activating programmed cell death in only the tumor cells (25). Betulin and betulinic acid may also be effective regarding improving metabolic syndrome symptoms, including obesity, diabetes, non-alcoholic fatty liver disease, heart disease, hypertension, and reduction in atherosclerotic plaques through its SREBP inhibiting function (9, 26, 27). As an added benefit to type II diabetes patients, as well as those wanting to balance their metabolism, betulin has also shown to reduce glucose absorption/uptake into the cell and increase insulin sensitivity by a myriad of different mechanisms (28, 29). Some other interesting properties of betulin and betulinic acid include being anti-bacterial and effective in wound healing (30, 31). The wound healing property has not only been utilized by Native cultures around the world for centuries, but also recently tested in humans (32). New research has demonstrated that betulin also inhibits proteins that cause the immune reaction to begin, causing decreased inflammation (33, 34). Betulin also inhibits stress inducing proteins in the cell (35), which contributes to its anti-inflammatory and anti-oxidative properties. This property has great implications in the neurodegenerative and psychiatric disease field because of the important link between neuroinflammation and neuropathology, moreover, betulin has direct interactions with hugely significant receptors like GABA in the brain (36). This has even led to clinical research being done with Souroubea simpetala (active ingredient: betulinic acid) against depression and anxiety (37).

We have thoroughly investigated the rare birch bark processing facilities worldwide including in-person auditing of a few sites with manufacturing and quality control experts proficient in GMP (Good Manufacturing Practice) compliant production of pharmaceutical drug compounds under FDA regulation. Among various methods of isolation and purification of betulin from the birch bark, we have selected and contracted with, a proprietary (patented) method based on ethanol extraction and several recrystallization and purification steps resulting in 98-99% pure betulin. The overall process is also environmentally friendly, with any organic solvents almost 100% recycled by distillation or used for other purposes. Before the release as an ingredient, betulin is tested for the presence of heavy metals, organic solvents, any microbial growth and a number of other parameters. This testing is performed in a third-party laboratory regulated by the GMP principles. Final formulation and capsulation of the betulin into the vegetarian capsules happens at a different manufacturing site specializing in these final steps of producing a commercial product out of pure ingredients. Final product manufacturer is also GMP certified, complies with the US FDA regulations, and is independent from the producer of the ingredient (betulin). As a result, the final product is subjected to its own round of analytical testing in a certified third-party laboratory to confirm identity and purity of betulin, in addition to the number of other standard parameters.

Nuveon Biosciences is heavily invested in scientific research. While there’s no guarantee that any of these will yield a positive result, we have multiple clinical and preclinical trials in progress as we continue to study BETULEX™ and lay the foundation for future products. Due to strong evidence pointing towards betulin’s metabolic effects, we will be conducting our own clinical trials of BETULEX™ to confirm its effects in people with various metabolic issues (high cholesterol, high lipids, high sugar, liver problems) including athletes actively building muscle mass and overloading on many supplements. Also, we will develop improved formulations of BETULEX™ to reach even higher levels of its biological activity and produce a flavored supplement suitable for children. Moreover, both orally available and topical formulations will be made that offer antiviral and wound healing support to cats and dogs based on BETULEX proven activities. We plan to launch a medical cosmetics line based on betulin’s amazing and clinically proven activity in topical application such as wound healing, skin diseases, burns and other conditions.

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