Kyzatrex, developed by Marius Pharmaceuticals, is the first oral testosterone replacement therapy (TRT) approved in the United States. It was created for men with low testosterone who want a more convenient alternative to injections or gels. Because of its unique oral delivery system, many men with hypogonadism are asking whether Kyzatrex is considered a controlled substance and what sets it apart from other types of testosterone therapy.
By looking at how Kyzatrex is regulated, how it works, its dosage, and potential risks, men can better understand what to expect from this new form of oral TRT.
Kyzatrex is a prescription capsule that delivers oral testosterone undecanoate to the body. Its generic name is testosterone undecanoate, a compound that has long been used in other forms of testosterone therapy, including testosterone injections and topical gel. What makes Kyzatrex different is its ability to provide steady oral testosterone replacement therapy through an easy-to-take capsule, reducing the need for regular clinic visits or daily topical applications.
Yes. All forms of testosterone, including oral testosterone replacement therapy, are regulated by the Food and Drug Administration (FDA) as Schedule III controlled substances.
This means take Kyzatrex only under the guidance of a healthcare provider. Testosterone has potential for improper use as an anabolic androgenic steroid, which is why it is restricted by law. The controlled status applies equally to oral testosterone, testosterone injections, and testosterone gel.
Kyzatrex is prescribed for hypogonadal men who have low or no testosterone levels due to specific medical conditions. Testosterone replacement therapy in adult males helps restore testosterone production to the normal range and reduces the symptoms of low testosterone. These symptoms may present as low energy, decreased muscle mass, loss of bone density, reduced sex drive, and mood changes.
Kyzatrex should only be used in men with low testosterone confirmed through testosterone testing. It is not intended for men with normal testosterone or for use in women.
Kyzatrex uses oral delivery to raise serum testosterone levels into the normal serum testosterone range. After swallowing, the medication is absorbed through the lymphatic system, reducing the chance of liver problems that occurred with older oral testosterone formulations.
Men taking Kyzatrex are monitored with regular serum testosterone and total testosterone testing. This ensures the testosterone concentration remains in the normal testosterone range without causing harmful side effects.
The typical starting dosage of Kyzatrex is 100 mg daily, divided into two doses taken with food. In some cases, 200 mg daily may be prescribed depending on serum testosterone level results.
A healthcare provider will usually check testosterone levels on day 90 to confirm effectiveness. Men should always take Kyzatrex with food to optimize absorption.
Kyzatrex offers several advantages as a new oral TRT option:
For many patients, oral therapy is the most convenient form of testosterone replacement therapy in adult males.
Like all forms of testosterone therapy, Kyzatrex carries risks that require close monitoring. Possible side effects may include:
Men may also notice acne, swelling, or mood changes. Side effects may include more frequent urination or symptoms related to an enlarged prostate.
If severe symptoms occur, men should report side effects to Marius Pharmaceuticals or the FDA.
Because Kyzatrex can increase red blood cell count, regular testing is important. Men using oral TRT should expect:
Men taking blood thinners need extra caution since TRT may affect clotting.
Alternatives to Oral Testosterone
While Kyzatrex is the first new oral TRT approved in the United States, men with low testosterone may also use other forms of testosterone therapy. Common options include testosterone injections, given weekly or monthly, and daily topical gel applications. In some countries, another oral form of testosterone undecanoate is also available to treat hypogonadal men.
Each treatment has benefits and drawbacks. Oral testosterone replacement therapy like Kyzatrex can provide steady serum testosterone levels without the peaks and troughs linked to injections, while gels may be effective but carry the risk of accidental transfer. Choosing the right option depends on testosterone testing, dosage requirements, and a discussion with a healthcare provider about safety and possible side effects.
Men starting Kyzatrex should:
Kyzatrex is a new oral testosterone replacement therapy approved by the Food and Drug Administration for adult men who have low testosterone due to certain medical conditions. While more convenient than injections or gels, it is still a Schedule III controlled substance and should only be used under the supervision of a qualified healthcare provider.
At 417 Integrative Medicine, we guide men through safe and effective options for oral TRT. If you have symptoms of low testosterone, schedule a consultation today to see if oral testosterone replacement therapy with Kyzatrex is the right choice for you.
