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New Testosterone Replacement Therapy Drug Approved by FDA


  • Low testosterone affects the quality of life of millions of aging men.
  • Testosterone replacement therapy is a solution for men suffering from testosterone deficiency.
  • The FDA has recently approved a testosterone undecanoate-based oral drug called Kyzatrex.
  • Kyzatrex works against hypogonadism (low testosterone), but it carries some risks and may cause adverse effects. 

The FDA has approved the oral testosterone replacement therapy drug Kyzatrex for the treatment of low testosterone levels in men. Kyzatrex boosts testosterone levels by introducing a testosterone prodrug called testosterone undecanoate into the body. Kyzatrex successfully boosts testosterone levels but has some side effects and risks. 

What Is Testosterone Undecanoate, and How Does It Work?

The active compound in Kyzatrex is testosterone undecanoate. Testosterone undecanoate is a testosterone ester, anabolic steroid, androgen, and testosterone prodrug. It is a substance doctors and fitness enthusiasts have used since the mid-1970s to fight hypogonadism and increase muscular gains. 

The non-medical use of this drug is illicit. In the U.S., testosterone undecanoate is a schedule III controlled substance. It does not provide benefits for those with normal testosterone levels. Those who choose to abuse it hoping it will improve their muscularity assume all its risks and will not reap any benefits. 

Intramuscular testosterone undecanoate has been in use for decades. Several oral versions of the drug have been approved in the U.S., Europe, and Canada over the last few years. Kyzatrex is the latest in this line. 

When delivered as an intramuscular injection, testosterone undecanoate has a long half-life in the body. It takes weeks to eliminate. Therefore, doctors only give an injection every three months. 

Oral Kyzatrex works differently. After you take the pills, your intestinal lymphatic system absorbs the molecule. Your thoracic duct then releases the androgen directly into your blood. 

Taking testosterone orally does not work because it must go through the liver, where the body deactivates it. However, oral testosterone undecanoate does not pass through your liver when your body metabolizes it. 

Instead, it lands in your bloodstream, where the body can break it down into testosterone and undecanoate. It further metabolizes testosterone into dihydrotestosterone and other androgens like 3-alpha-androstenediol and 3-beta-androstenediol. 

The Benefits of Testosterone Undecanoate

Testosterone replacement therapy is a time-honored solution for restoring normal testosterone levels in men whose bodies can’t produce enough of this essential androgen. 

Low testosterone levels lead to many health problems and can ruin your quality of life. Low testosterone can cause: 

  • Depression
  • Loss of muscle and bone mass
  • Increased body fat
  • Increased likelihood of developing age-related diseases
  • Low energy
  • Insomnia
  • Low libido and loss of sexual function
  • Headaches
  • Acne 

By restoring normal testosterone levels, testosterone replacement therapy drugs like Kyzatrex can counteract or prevent these problems. 

The FDA approved the drug for the treatment of conditions like: 

Doctors recommend that patients suffering from hypogonadism take a 200 milligram dose of Kyzatrex twice a day with food. This regimen allows Kyzatrex to mimic the normal rhythm of testosterone production. 

Before starting testosterone replacement therapy with Kyzatrex, patients should be sure that they suffer from testosterone deficiency. Measuring serum testosterone levels is now possible at home with the help of a home testosterone kit

Kyzatrex Risks

Testosterone replacement therapy may sound straightforward, but nothing involving hormones is simple. TRT carries many risks and side effects, and Kyzatrex is no exception. 

Most people tolerate testosterone undecanoate well, but as with any medication, there is a risk of allergic reaction. If you notice allergic symptoms after taking the drug, seek medical help immediately.

The very severe side effects of the drug include: 

  • Fainting
  • Difficulty breathing
  • Vision changes
  • Difficulty speaking
  • Sudden headaches
  • Pain, swelling, or warmth in the groin
  • Unusual sweating
  • Weakness on one side of the body 

All these problems require immediate medical attention. 

Severe side effects can include: 

  • Anxiety, depression, sudden mood swings
  • Sleep apnea
  • Persistent vomiting
  • Abdominal pain
  • Jaundice and other signs of liver disease
  • Dark urine
  • Frequent urination
  • Irregular heartbeat
  • Long erections that won’t quit
  • Breast enlargement and tenderness 

According to its FDA label, Kyzatrex can cause other serious side effects, like:  

  • Increasing the number of red blood cells, raising the risk of blood clots, heart attacks, etc.
  • Aggravating the symptoms of enlarged prostate
  • Increasing the risk of prostate cancer
  • Lowering sperm count in higher-than-recommended doses
  • Swelling of the ankles, feet, and body
  • Raising LDL (bad) cholesterol levels 

Some patients should avoid taking Kyzatrex altogether. The drug can be harmful to people: 

  • Whose hypogonadism is not genetic or structural
  • Who are hypersensitive to testosterone undecanoate
  • Who have prostate cancer

Kyzatrex’s Effects on Blood Pressure

Hypertension is the most common adverse effect of the drug. 

A 2021 study found that Kyzatrex caused the blood pressure of patients to go up slightly after 120 days of treatment. After 180 days, researchers noticed no further increases. 

Patients already on medication for hypertension were the most likely to show significant blood pressure increases. 

What Is Hypogonadism?

Again, Kyzatrex (and all other forms of testosterone replacement therapy) are only recommended for men who have hypogonadism. But what exactly is hypogonadism?

Hypogonadism is another name for testosterone deficiency, or low T. Sometimes, the body does not produce sufficient amounts of testosterone. Low testosterone levels may result from problems with the testes (primary hypogonadism) or problems with the pituitary gland or hypothalamus (hypogonadotropic hypogonadism). 

Primary hypogonadism results from damage to the testes. The damage can be physical or the result of an autoimmune condition.   

Hypogonadotropic hypogonadism can have many causes, from genetic defects to stress and substance abuse. 

In some cases, testosterone deficiency results from a combination of testicular and other problems. 

Doctors measure the levels of hormones like follicle-stimulating hormone, luteinizing hormone, and prolactin to determine the cause of testosterone deficiency. 

Testosterone undecanoate-based solutions like Kyzatrex work in all cases. 

Higher-than-normal testosterone levels do not offer people additional health benefits. Those who try to improve their physiques by abusing drugs like testosterone undecanoate find that the side effects always outweigh the temporary benefits. 

Only take testosterone replacement therapy drugs if your doctor prescribes them for low T. 

eDrugstore Can Help You Monitor Your Testosterone

We carry affordable home testosterone test kits you can use to measure your testosterone levels, and it’s easy! 

  • Order the home testosterone kit.
  • Follow the instructions to collect a sample.
  • Return the sample.
  • Get your results in 2-5 days. 

If your results fall outside the optimal range, we provide a free consultation with a U.S.-licensed doctor to determine how you should proceed. When you order from eDrugstore, medical consultations and shipping are always free.

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