Kyzatrex could be a potential blockbuster for treating testosterone deficiency, a severely undertreated condition.
Testosterone has always been seen as a lifestyle issue for men who want to improve their sex life or for gym goers who want to experience massive muscle gains. Extensive research has been conducted on hormonal imbalance and its significant downstream impact on human organs and processes.
Testosterone deficiency, or hypogonadism, is a disease in which a man’s body does not produce enough testosterone. Usually it is treated with testosterone replacement therapy, which replaces testosterone that has been lost and returns levels to normal.
It is believed that more than 20 million men in the United States suffer from hypogonadism. (Globally, more than 100 million men suffer from the disease.) Additionally, more than a third of men over 40 and about 40% of men over 45 suffer from a deficiency of testosterone and suffer from many symptoms, such as fatigue, inflammation, weight gain. , low libido, depression and poor cognition.
Now a new prescription drug, developed and manufactured by Marius Pharmaceuticals, based in Raleigh, North Carolina, has been approved by the United States Food and Drug Administration to treat adult men who have low testosterone levels or void due to certain medical conditions. Marius, a specialty pharmaceutical company, is founded by American Indian Himanshu H. Shah.
Traditionally, testosterone replacement therapy consisted of testosterone patches, gels, lozenges and injections. The new drug, Kyzatrex, which received FDA approval in July 2022, is an oral drug. It is effective in treating symptomatic men with low testosterone levels below 300 nanograms per deciliter (ng/dL). A nanogram is one billionth of a gram and a deciliter is 1/10 of a liter. Testosterone is measured by blood tests. According WebMD“Most doctors agree that a ‘normal’ reading is between 300 and 1,000 nanograms per deciliter (ng/dL).
Kyzatrex, which comes in dosages of 100mg, 150mg, and 200mg, can be taken twice a day with food. It will be available in all US states from October 15, 2022.
In an interview with The American Bazaar last week, Shah, who is the executive chairman of Marius, cited several benefits of Kyzatrex. Since the capsule is absorbed through the lymphatic system, bypassing the liver, it avoids liver toxicity and liver damage, he said. “The oral delivery method eliminates the risk of application site reactions common with intramuscular injections,” Shah said. “Kyzatrex also eliminates any risk of transmission to women or children that may occur with topical testosterone gels and creams. Kyzatrex’s daily dosage more closely mimics the daily rhythm of natural testosterone production compared to long-acting therapies.
Shah, who is also the managing general partner of the Shah Capital Opportunity Fund, spoke about the need to dispel misconceptions about testosterone and testosterone therapy. Even though it is a true medical blind spot – with its immense potential for reducing downstream disease – many doctors are hesitant to prescribe testosterone therapy due to debunked claims that it causes cancer of prostate and cardiovascular risks, he said.
A number of massive observational studies over the past five years have assessed the effect of testosterone therapy on prostate cancer and cardiovascular disease and found that testosterone therapy is in fact cardioprotective. and not not cause prostate cancer. A recent large observational study that analyzed data from over 143,000 American men over the age of 65 found that testosterone therapy was associated with increased lower incidence prostate and colorectal cancers.
Shah said Marius is focused on “adequate testosterone therapy (ATT), a trademark mantra for improving patient outcomes while simultaneously reducing unnecessary healthcare costs. “There are studies that show testosterone therapy produces weight reductions in overweight and obese people,” he said. “Similarly, another study evaluating the impact of testosterone therapy on pre-diabetics and type 2 diabetics found that testosterone therapy resulted in remission in 33% of pre-diabetics and type 2 diabetics. type 2. Testosterone levels should be checked by routine blood test in comorbid patients who might benefit from ATT.
Shah touted Kyzatrex’s huge market potential, given the size of the population affected by testosterone deficiency and the benefits of testosterone treatment. He said he expects the drug to outsell Viagra in the long run. “Viagra only treats one condition, while Kyzatrex could treat many more,” he said.
FDA approval for the drug came after 13 years of clinical studies, including phase 3 trials, conducted at 35 sites across the United States. Men from various demographic groups, including African Americans, Asian Americans and Hispanics, were part of the studies. In the first phase 3 study, which lasted 12 months, there were 314 subjects in total. The second phase 3 study lasted approximately nine months and included 155 subjects. The most common side effect of the drug in clinical trials was hypertension, which only occurred in 2.6% of subjects.
Patients can register for medicines by visiting the virtual health platform BaseHealthcare.com, which performs comprehensive lab work and offers a telehealth visit with a clinician. Alternatively, Kyzatrex can be prescribed by an existing physician and ordered through the website www.kyzatrexdirect.com with medicines shipped directly to the patient’s home at launch. “BaseHealthcare.com is a virtual men’s health platform focused on foundational health and optimization using testosterone and patient-centered health coaching,” Shah said.