THE CLINICAL CASE FOR KYZATREX®

Clinically Proven FDA-Approved Oral Testosterone Capsule

The Mechanism
Lymphatic absorption.
Avoids first pass metabolism1,2
Not a 17-alpha-alkylated androgen.
The Result
Up to 96% back in range.
Day 90.¹*
Phase III study. 139 men.

Bypasses Your Liver, By Design

KYZATREX utilizes a Self-Emulsifying Drug Delivery System (SEDDS) enhanced with phytosterol esters to deliver testosterone undecanoate (TU) via the intestinal lymphatic system, bypassing the liver and avoiding first-pass metabolism.1,2
Previous-generation oral testosterone agents were 17-alpha-alkylated androgens associated with significant hepatotoxicity risk. KYZATREX is not a 17-alpha-alkylated androgen and is not known to cause hepatic adverse effects.1
Reliable Absorption
When taken with a fat-containing meal - no special dietary requirements beyond
a meal.1
Consistent Serum Levels
Within normal range with appropriate titration - no extreme peaks or troughs.1,2
No Hepatotoxicity Risk
Not a 17-alpha-alkylated androgen. Not associated with hepatotoxicity risks of older oral testosterone agents.1
Physiologic Pattern
Designed to restore and maintain testosterone levels in a physiologic pattern following each dose.1,2
PHASE III CLINICAL EFFICACY

Peer-Reviewed & Published in 2024

In a 6-month, open-label Phase III study of 139 hypogonadal men (median age 50; range 22–66):2,3
30% Decrease in Mean
SHBG* Levels3
Patients who completed the trial achieved normal testosterone levels at Day 90 (n=127)2*
Patients achieving Cavg 222–800 ng/dL at Day 90 - worst-case calculation (n=139)
Increase in mean free testosterone levels from baseline at Day 902
*In a 6-month clinical trial of 139 men with low testosterone, 88% of patients achieved normal testosterone levels at Day 90 (worst-case scenario analysis, excluding Investigator Site 104). Among patients who completed the study (n=127), 96% achieved normal testosterone levels at Day 90. * 95% CI: worst-case 82%–93%; completers 93%–99%.2

Approved Indication and Limitations of Use

Actor Portrayals.
INDICATION:

KYZATREX (testosterone undecanoate) capsules, CIII, is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:1

  • Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.
  • Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, pituitary-hypothalamic injury from tumors, trauma, or radiation.
Limitations of Use:

Safety and efficacy in males under 18 years of age have not been established. Safety and efficacy in men with age-related hypogonadism have not been established.1

DOSING & TITRATION

Start at 200 mg BID, Titrate at 7 Days

*Not actual size
Also available in 150 mg
Parameter
Details
Starting dose
200 mg BID with a fat-containing meal1
Titration assessment
Day 7; blood draw 3–5 hours post-morning dose1
Available capsule strengths
150 mg, or 200 mg1
Dose adjustment options
Adjust based on serum testosterone Cavg1
Target range
Normal testosterone range (222–800 ng/dL Cavg); titrate to lowest effective dose within normal range1
⚠︎ KYZATREX is not substitutable with other oral testosterone undecanoate products. The unique SEDDS formulation drives distinct pharmacokinetic behavior that cannot be assumed equivalent to other oral TU products.1
Based on ambulatory blood monitoring in a clinical study, KYZATREX increased mean systolic/diastolic blood pressure by 1.7/0.6 mm Hg from baseline after 4 months of treatment and 1.8/0.6 mm Hg from baseline after 6 months of treatment. In patients with hypertension on antihypertensive therapy, KYZATREX increased the mean systolic/diastolic BP by 3.4/0.7 mm Hg from baseline after 4 months of treatment and 3.1/1.0 mm Hg from baseline after 6 months of treatment.
SAFETY PROFILE

How Often Do you Test?

Blood Pressure
Monitor periodically. Not recommended in patients with uncontrolled hypertension.1
Hematocrit
Prior to initiation and every 3 months. Discontinue if persistently elevated.1
Most common adverse reaction - hypertension - in a clinical study of 155 patients.1,2
One patient discontinued due to an adverse reaction (acne).
No patients discontinued due to erythrocytosis.1
PSA
Before and during treatment per
standard of care.1
Lipid Profile
Periodically. Adjust lipid-lowering
therapy if necessary.1
⚠︎ Please see additional risks in Important Safety Information below and KYZATREX Full Prescribing Information.

KYZATREX vs. Other TRT Options

*Not actual size, Also available in 150 mg

Oral TRT.

KYZATREX Direct makes it easy to bring KYZATREX to your practice.

References:

    1. KYZATREX [Prescribing Information]. Raleigh, NC: Marius Pharmaceuticals; 2025.
    2. Bernstein JS, Dhingra OP. A phase III, single-arm, 6-month trial of a wide-dose range oral testosterone undecanoate product. Ther Adv Urol. 2024;16:17562872241241864. doi: 10.1177/17562872241241864
    3. Data on file. Raleigh, NC: Marius Pharmaceuticals, 2020.