RedefiningTestosterone Therapy

A patient-centric healthcare company focusing on therapies designed for testosterone deficiency

About Marius

We are paving the way for a new frontier in testosterone.

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Marius Pharmaceuticals is paving the way for a new frontier in testosterone. We believe that testosterone is central to overall health and wellbeing, which is why we have spent more than a decade developing a proprietary oral testosterone therapy to help the millions suffering from the unwanted symptoms of testosterone deficiency.

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Impact of T

How crucial is Testosterone?

The crucial role that testosterone plays in the human body has been neglected for far too long with patients bearing the consequences. Aside from its well-known role as the “sex hormone,” testosterone is essential to many bodily functions…


Testosterone may play an important role in brain health and cognitive function, with low levels causing issues with memory, clarity, and concentration. Mood disorders, like anxiety and depression, can be exacerbated by low testosterone levels.


Muscle development, fat metabolism, and bone strength are all dependent on testosterone. Testosterone is key in stimulating muscle tissue growth, increasing bone density and by controlling metabolic efficiency, the hormone indirectly decreases body fat and glucose concentrations.


Many studies have shown that testosterone is actually cardioprotective and is key in regulating blood flow, inflammation, and vascular function.


The hormone serves a meaningful role in sex drive and performance. When levels are too low, individuals may experience low libido and erectile dysfunction.

An FDA-approved prescription oral softgel for adult men who have low or no testosterone due to certain medical conditions.


KYZATREX™ (testosterone undecanoate) is an FDA-approved oral softgel capsule for testosterone deficiency.

The safety and efficacy of KYZATREX™ in males less than 18 years old have not been established.

Drug Dosage

Designed for oral delivery, KYZATREX™ should be taken twice a day – morning and evening – with food.

Available in 100 mg, 150 mg, and 200 mg strengths.

Effect of Kyzatrex

Phase 3 study results showed that 88% of hypogonadal men who completed 90 days of KYZATREX™ treatment achieved average testosterone levels in the normal range (222-800 ng/dL) with no drug-related serious adverse effects or liver issues.

The most common side effect (≥2%) was high blood pressure (2.6%). Please see Important Safety Information below, including Boxed Warning for increased blood pressure.

The Frontiers of Testosterone Therapy

Evidence supports the need for research initiatives to examine hormone imbalance within other comorbidities and patient populations.


Obesity and low testosterone levels are closely related with numerous studies having established an inverse relationship between the two. Studies have shown that long-term testosterone therapy in men with testosterone deficiency produces significant weight loss, notable reduction in waist circumference and BMI, and improvements in body composition.1

Type 2 Diabetes

Testosterone therapy has shown promising success in individuals with type 2 diabetes. T4DM was a randomized, double-blind, placebo-controlled, 2-year phase 3B trial that examined the effects of testosterone therapy in men with type 2 diabetes. One-third of the men treated with testosterone saw remission of their diabetes. The testosterone group saw greater decrease in waist circumference, total and abdominal fat mass, and fasting glucose. The magnitude of effect of testosterone to prevent type 2 diabetes was greater than that seen for metformin in the Diabetes Prevention Program.2


The benefits of testosterone therapy are not limited to just men. The potential uses of testosterone therapy for women are becoming increasingly evident. For example, testosterone reduces the symptoms of menopause and poses no major adverse side effects. Healthy young women have up to 20x more testosterone than estrogen.3


Base Healthcare Launches Innovative Platform for Men with Testosterone Deficiency

Oct. 18, 2022

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

August 2, 2022

Marius Announces Ambulatory Blood Pressure Results Published in the Journal of Clinical Hypertension with their new testosterone medication KYZATREX

June 11, 2021

Marius Pharmaceuticals Receives PDUFA Date for KYZATREX® NDA for Treatment of Hypogonadism

March 11, 2021

Marius Pharmaceuticals Announces Co-CEOs Himanshu H. Shah and Shalin Shah to Drive Growth ahead of Anticipated FDA Action of its Lead Asset, KYZATREX

January 27, 2021

Marius Pharmaceuticals Submits New Drug Application to U.S. FDA for Next-generation Oral Testosterone Replacement Therapy in Male Patients with Hypogonadism

January 5, 2021

Marius Pharmaceuticals Announces Issuance of Two Key Patents Protecting its Proprietary Oral Testosterone Therapy

May 21, 2020

Marius Pharmaceuticals Completes Efficacy Phase 3 Study

September 26, 2018


Meet Our Thought Leaders

We’re a growing team of innovative trailblazers and thought leaders.

With over 100 years of combined experience, we’ve got a well-seasoned team at the wheel.

Himanshu H. Shah
Himanshu H. Shah

Executive Chairman / Founder

Shalin Y. Shah

Chief Executive Officer

Amit Shah

Chief Operations Officer

Board of Directors

Himanshu H. Shah
Himanshu H. Shah

Executive Chairman / Founder

Amit Shah

Board Director / Chief Operations Officer

Ramesh Mahalingham

Operating Board Director

Om Dhingra

Board Director / Scientific Advisor

Board of Advisors

Abraham Morgentaler, MD
Abdulmaged Traish, PhD
Paresh Dandona MD, PhD
Sandeep Dhindsa, MD
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Join Us

Join our team in setting the standard for the future of preventative healthcare.

We’re looking for people who love to think outside of the box, solve complex issues, and work alongside an enthusiastic team of movers and shakers.

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Important Safety Information for KYZATREX™ (testosterone undecanoate)

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.


KYZATREX™ (testosterone undecanoate) is a prescription drug that is used to treat adult men who have low or no testosterone levels due to certain medical conditions.

KYZATREX™ is a controlled substance (CIII) because it contains testosterone. It is not known if KYZATREX™ is safe or effective in males younger than 18 years old. Improper use may affect bone growth in children. KYZATREX™ is not meant for use by women.

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.

  1. 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.
  2. If your blood pressure cannot be controlled, KYZATREX™ may need to be stopped.
  3. Your healthcare provider will monitor your blood pressure while you are being treated with KYZATREX™.

Do not take KYZATREX™ if you: have breast cancer; have or might have prostate cancer; are a woman who is pregnant (KYZATREX™ may harm your unborn baby); are allergic to KYZATREX™ or any of its ingredients; or have low testosterone without certain medical conditions (e.g., do not take KYZATREX™ if you have low testosterone due to age).

Before you take KYZATREX™, tell your healthcare provider about all of your medical conditions, including if you: have high blood pressure or are treated for high blood pressure; have a history of diabetes; have heart problems; have high red blood cell count (hematocrit) or high hemoglobin laboratory value; have urinary problems due to an enlarged prostate; have liver or kidney problems; or have problems breathing while you sleep (sleep apnea).

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking KYZATREX™ with certain other medicines can affect each other. <strong>Especially, tell your healthcare provider if you take:</strong> insulin; medicines that decrease blood clotting (blood thinners); corticosteroids; or medicines that increase blood pressure, such as some cold medicine and pain medicines.

KYZATREX™ may cause other serious side effects including:

  1. Increase in red blood cell count (hematocrit) or hemoglobin, 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.
  2. If you already have an enlarged prostate, your signs and symptoms may worsen while taking KYZATREX™. 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.
  3. Increased risk of prostate cancer.
  4. Blood clots in the legs or lungs. 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.
  5. 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.
  6. In large doses, KYZATREX™ may lower your sperm count.
  7. Liver problems. 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).
  8. Swelling of your ankles, feet, or body (edema), with or without heart failure.
  9. Enlarged or painful breasts.
  10. Breathing problems while you sleep (sleep apnea).

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effect of KYZATREX™ is high blood pressure.</strong> Other side effects may include: headache, joint or back pain, diarrhea, increased red blood cell count, anxiety, constipation, swelling of the legs, and increased prostate specific antigen (PSA) levels.

These are not all the possible side effects of KYZATREX™. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You may also report side effects to Marius by visiting

Keep KYZATREX™ and all medicines out of the reach of children.

See Full Prescribing Information and Medication Guide for KYZATREX™.


  • Obesity 1 Karim Haider, MD, Ahmad Haider, MD, Gheorghe Doros, PhD, Abdulmaged Traish, PhD, Farid Saad, DVM, PhD, MON-091 Profound and Sustained Weight Loss in Men With Hypogonadism and Obesity Receiving Long-Term Testosterone Therapy (TTh) with Testosterone Undecanoate Injections (TU): 10-Year Data from a Registry Study in a Urological Setting, Journal of the Endocrine Society, Volume 3, Issue Supplement_1, April-May 2019, MON– 091
  • Type 2 Diabetes 2 Wittert, G., Bracken, K., Robledo, K. P., Grossmann, M., Yeap, B. B., Handelsman, D. J., Stuckey, B., Conway, A., Inder, W., McLachlan, R., Allan, C., Jesudason, D., Fui, M., Hague, W., Jenkins, A., Daniel, M., Gebski, V., & Keech, A.(2021). Testosterone treatment to prevent or revert type 2 diabetes in men enrolled in a lifestyle programme (T4DM): a randomised, double-blind, placebo-controlled, 2-year, phase 3b trial. The lancet. Diabetes & endocrinology, 9(1), 32–45.
  • Women 3 Mok, Charles. Testosterone: Strong Enough For A Man, Made For A Woman. Forbes Books, 2017.