Home CompaniesMarius Pharmaceuticals Marius Pharmaceuticals Receives FDA Approval of KYZATREX™, an Oral Testosterone Replacement Therapy

Marius Pharmaceuticals Receives FDA Approval of KYZATREX™, an Oral Testosterone Replacement Therapy

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Summary :

  • Marius Pharmaceuticals, a patient-centric healthcare company, today announced the approval of KYZATREX™ (testosterone undecanoate) by the U.S. Food and Drug Administration (FDA). KYZATREX™ is an oral testosterone replacement therapy (“TRT”) indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism.
  • The approval of KYZATREX™ provides an important option in treating hypogonadism or more commonly known as, Testosterone Deficiency, which affects approximately 40% of men older than 45 years of age and 30-50% of men with obesity or type 2 diabetes have hypogonadism.
  • KYZATREX™ has been approved in three dosage strengths, 100mg, 150mg, and 200mg.


Description: Kyzatrex is a prescription medicine used to treat the symptoms of Hypogonadism, Delayed Puberty in Males, and Inoperable Mammary Cancer in Women. Kyzatrex may be used alone or with other medications. Kyzatrex belongs to a class of drugs called Androgens.

  • Class :Anabolic steroids; Androstenols; Hormonal replacements; Small molecules; Testosterone congeners
  • Mechanism of Action :Testosterone replacements
  • Orphan Drug Status : Yes – Hypogonadism
  • New Molecular Entity :No
  • Available For Licensing: Yes
  • Indication : Hypogonadism

Important Safety Information for KYZATREX™

KYZATREX™ can increase blood pressure, which can increase the risk of having a heart attack or stroke and can increase risk of death due to a heart attack or stroke. Your risk may be greater if you have already had a heart attack or stroke or if you have other risk factors for heart attack or stroke.

  • If your blood pressure increases while on KYZATREX™, blood pressure medicines may need to be started. If you are currently taking blood pressure medicines, they may need to be changed or new blood pressure medicines may need to be added to control your blood pressure.
  • If your blood pressure cannot be controlled, KYZATREX™ may need to be stopped.
  • Your healthcare provider will monitor your blood pressure while you are being treated with KYZATREX™.

KYZATREX™ may cause other serious side effects including:

  • Increase in red blood cell count (hematocrit) orhemoglobin, which can increase the risk of blood clots, strokes, and heart attacks. You may need to stop KYZATREX™ if your red blood cell count increases.
  • Ifyoualreadyhaveanenlargedprostate,yoursignsandsymptomsmayworsenwhiletakingKYZATREX™. These may include: increased urination at night; trouble starting your urine stream; urinating many times during the day; urge to go to the bathroom right away; a urine accident; inability to pass urine or weak urine flow.
  • Increased risk of prostate cancer.
  • Bloodclotsinthelegsorlungs. Signs and symptoms of a blood clot in your leg can include pain, swelling or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
  • Abuse. Testosterone can be abused when taken at higher than prescribed doses and when used with other anabolic androgenic steroids. Abuse can cause serious heart and psychological side effects.
  • In large doses, KYZATREX™ may lower your spermcount.
  • Liverproblems. Symptoms of liver problems may include: nausea or vomiting; yellowing of your skin or whites of your eyes; dark urine; pain on the right side of your stomach area (abdominal pain).
  • Swelling of your ankles, feet, or body (edema), with or without heartfailure.
  • Enlarged or painfulbreasts.
  • Breathing problems while you sleep (sleepapnea).

“I would like to congratulate our scientific team on this major milestone, and now it is up to our commercial team to make KYZATREX™ a leading therapy and a go-to brand for millions of hypogonadal men in the U.S. Low Testosterone affects numerous metabolic factors as well as often overlooked, true quality of life, hence annual testosterone testing should be mandatory for men over age 40,” remarked Himanshu H. Shah, Chairman of Marius.

KYZATREX™ is a proprietary oral softgel capsule that is absorbed primarily via the lymphatic system, avoiding liver toxicity. The oral delivery method eliminates the risk of application site reactions common with intramuscular testosterone injections as well as potential transference to women or children that can occur with topical testosterone gels and creams. With daily dosing in the morning and evening (with food), KYZATREX™ more closely mimics the daily rhythm of natural testosterone production compared to long-acting therapies.

“With so many men suffering daily effects of Testosterone Deficiency and often abandoning or not electing to get treatment, we see FDA-approved KYZATREX™ as a newly viable oral option that has demonstrated safety and effectiveness. Further, Testosterone Deficiency is a big blind spot in medicine today and our research will continue to explore the importance of testosterone in both male and female health,” commented Shalin Shah, CEO of Marius.

KZAYTREX™ has the potential to become the new gold standard of care for treating patients with hypogonadism. There are at least six million symptomatic men suffering from hypogonadism in the U.S., and over 100 million men globally.

About Testosterone and Hypogonadism

Hypogonadism, often referred to as Testosterone Deficiency, is a condition that occurs when the body does not produce adequate levels of testosterone. Primary hypogonadism (testicular failure due to certain conditions) and hypogonadotropic hypogonadism both result in low serum testosterone concentrations. In addition to testosterone’s widely accepted role in sexual and reproductive function, it also has important roles in numerous other metabolic and inflammatory process and is one of the most common causes of secondary osteoporosis in men. Patients with hypogonadism may experience fatigue, low energy, decreased muscle mass, weight gain, low libido, poor cognition, difficulty sleeping, and other mood disorders, such as depression and anxiety. Because low levels of testosterone can also increase the risk of developing type 2 diabetes and obesity, hypogonadism is a common comorbidity in a broader set of conditions, including type 2 diabetes and Non-Alcoholic Steatohepatitis (NASH).

About Marius Pharmaceuticals

Marius Pharmaceuticals is a patient-centric healthcare company focusing on therapies designed for hypogonadism or Testosterone Deficiency. The company’s mission is to improve the functional lives of patients by reducing the downstream effects of Testosterone Deficiency, which include multiple comorbidities, such as type 2 diabetes and obesity.

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