Actor Portrayal
Simplifying Testosterone Treatment
KYZATREX®:
The Next Level in
Testosterone
Replacement Therapy (TRT)
Offer patients a simple, painless way to manage low testosterone with twice-daily oral capsules.
KYZATREX is helping patients ditch the painful injections and messy gels for an oral option that fits effortlessly into everyday life.
*In a six-month open-label clinical study (n=139) of men with low testosterone, 88% achieved Cavg 222-800 ng/dL at Day 90 (worst case scenario calculation, Investigator Site 104, 95% CI, 82% to 93%).
Based on end-of-study completers (n=127), 96% of patients achieved Cavg 222-800 ng/dL at Day 90 (95% CI, 93 to 99%).
KYZATREX is Optimized for Lymphatic Uptake
KYZATREX utilizes a Self-Emulsifying Drug Delivery System (SEDDS) enhanced with phytosterol esters to route testosterone undecanoate (TU) through the intestinal lymphatic system, bypassing the liver and avoiding first-pass metabolism.1,2
A Broad PK Profile Without Extreme Peaks and Troughs1,3,4
KYZATREX is designed to restore and maintain testosterone levels in a
physiologic pattern following each dose.
Mean Concentration-Time Profile (N=139)
Mean (Standard Error of the Mean) Testosterone Concentration (ng/dL) Post Morning KYZATREX Dose at Day 90. KYZATREX safely restores T levels while allowing the hypothalamic-pituitary-gonadal (HPG) axis to remain active. T levels return to near baseline between KYZATREX doses, maintaining HPG axis function.3
Clinically Restore Testosterone Levels
The efficacy of KYZATREX was evaluated in a 6-month open-label clinical study involving 139 hypogonadal men (median age of 50 years; range 22 to 66 years). The primary efficacy endpoint was the percentage of KYZATREX-treated patients with mean plasma total testosterone concentration (Cavg) over 24-hours within the normal range of 222-800 ng/dl on the final PK visit of the study at Day 90.
KYZATREX demonstrated the following at Day 90:
*Sex Hormone Binding Globulin (SHBG) binds to testosterone and decreases free testosterone levels. The less SHBG you have, the higher your free testosterone levels will be.5
Demonstrated Safety Profile
Endpoint
MRS-TU-2019EXT Study (N = 155)
ABPM
Change in 24-hour mean SBP from baseline after 4 months of KYZATREX, mmHg (95% CI)
1.7 (0.3-3.1)
Change in 24-hour mean SBP from baseline after 6 months of KYZATREX, mmHg (95% CI)
1.8 (0.3-3.2)
(Mean change from baseline at 6 months)
PSA
0.15 (±0.04) ng/mL
Hemoglobin
0.48 g/dLTotal Cholesterol
11.1 mg/dL
Triglycerides
18.6 mg/dL
Fasting Insulin†
5.2 μU/mL
†Data from MRS-TU-2019 (n=153) at 12 months. Fasting insulin was an exploratory endpoint; this study was not designed or statistically powered to demonstrate differences in exploratory endpoints.
ABPM: ambulatory blood pressure monitoring; CI: confidence interval; SBP: systolic blood pressure.
Adverse Events in ≥2% of Patients Receiving KYZATREX3
Hypertension: 2.6%
One patient who received KYZATREX experienced an adverse reaction (acne) that led to premature discontinuation from the study.1,3
No patients discontinued due to erythrocytosis.1,3
In a 12-month, open-label clinical study, men who received KYZATREX 200 mg QD to 400 mg BID (n = 202) reported the following additional adverse reactions: headache, arthralgia, diarrhea, hemoglobin increased, anxiety, constipation, peripheral edema, and prostate-specific antigen increased.3
Provider and Patient Preference for Oral Testosterone6
KYZATREX Daily Oral Dosing
Testosterone-boosting benefits taken twice a day with food3
Dosing Flexibility
Meet your patient’s testosterone needs with a range of
KYZATREX doses.
References:
- 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;16:1-17. doi: 10.177/17562872241241864
- Kanabur P, Brunner R, Khera D, et al. The Evolving Role of Novel Oral Agents for Testosterone Replacement Therapy; A Historical Perspective. Adrog Clin Res Ther. 2022;3.1:224-232. doi: 10.1089/andro.2021.0025
- KYZATREX [prescribing information]. Raleigh, NC: Marius Pharmaceuticals; 2025.
- Data on file. Raleigh, NC: Marius Pharmaceuticals, 2020.
- Krakowsky Y, Grober E. Testosterone deficiency – Establishing a Biochemical Diagnosis. EJIFCC. 2015 Mar; 26(2): 105–113.PMID: 27683486; PMCID: PMC4975356.
- Data on file. Raleigh, NC: Marius Pharmaceuticals, 2018.
