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#1 perscribed oral TRT*

How JATENZO avoids Liver
toxicity while raising T Levels1-3

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Mode of Absorption

Not your first generation oral1,3,4

The first FDA-approved oral softgel testosterone replacement therapy (TRT)
specifically designed for safe oral delivery of testosterone undecanoate (TU), which:

  • is absorbed via the intestinal lymphatic system,
  • avoids first-pass hepatic metabolism; and
  • in clinical trials, there were no liver toxicity-related events observed

Mode of absorption1-3

JATENZO (testosterone undecanoate) avoids first-pass hepatic metabolism

JATENZO is a prodrug formed by adding undecanoate, a fatty acid, to the molecular structure of testosterone.

Designed for absorption in the intestinal lymphatic system1-3,7

JATENZO’s unique formulation is designed to be absorbed and distributed through the intestinal lymphatic system—the pathway responsible for the transport of dietary lipids.

Mode of absorption avoids first-pass hepatic metabolism1-3,7

The intestinal lymphatic system transports JATENZO to the body’s circulatory system where the fatty acids are cleaved to produce testosterone.

JATENZO offers safe, oral delivery1-3

JATENZO’s testosterone undecanoate formulation and route of administration avoids liver toxicity issues associated with older forms of oral testosterone.

 

 

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JATENZO raised T levels to the normal range in 87.3% of men5

Primary efficacy endpoint:

Exceeded FDA target of ≥75% of men in eugonadal range5

Primary outcome was the percentage of patients with mean T concentration (Cavg) over 24-hours achieved eugonadal T levels on the final PK visit of the study.1,2

MEN ACHIEVED STEADY STATE T LEVELS WITHIN 7 DAYS5

7 days after starting JATENZO, a patient’s serum testosterone level reaches peak trough stability, minimizing supraphysiologic fluctuations while maximizing therapeutic benefit.1,5

JATENZO’s starting dose may be evaluated and titrated, as early as eight days after treatment initiation.1

JATENZO MAINTAINED NORMAL T LEVELS OVER EACH 12-HOUR DOSING INTERVAL1,6*

Normal range according to general thought is 300-1000 ng/dL. Average concentration of NaF-EDTA plasma T was measured in patients as 306-1101 ng/dL and converted to approximate serum T equivalents by a conversion factor of 1.21x.2

Free T increased and SHBG decreased2,5

Relevant lab values for JATENZO

Only free T (or its active metabolite, DHT) can bind to androgen receptors in tissue to exert their biological effects.7

SHBG tightly binds T in blood and thus limits the concentration of free T.7

The inTUne clinical study used 2% topical testosterone solution as the active control arm. These analyses were exploratory and were not used to assess efficacy.5

†Free T concentrations were calculated using the Vermeulen formula based on T, SHBG, and albumin concentrations.2

Patient reported Impact on symptoms2,5

Effects of JATENZO on mean change from baseline in Psychosexual Daily Questionnaire (PDQ) in hypogonadal men2,8

Significant increases in lean body mass and fat loss4

Effects of JATENZO at 6-and 12-months on mean (±) changes from baseline in lean body mass and fat mass in a 12-month study4

DHT=dihydrotestosterone; PK=pharmacokinetics; SHBG=sex hormone-binding globulin; T=testosterone

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IMPORTANT SAFETY INFORMATION FOR JATENZO (testosterone undecanoate)

Indication and Limitations of Use:

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

  • Primary hypogonadism (congenital or acquired)
  • Hypogonadotropic hypogonadism (congenital or acquired)

Safety and efficacy of JATENZO in men with “age-related hypogonadism” and in males less than 18 years old have not been established.

IMPORTANT SAFETY INFORMATION FOR JATENZO (testosterone undecanoate)

CONTRAINDICATIONS

JATENZO is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate, in women who are pregnant, or in men with a known hypersensitivity to JATENZO or its ingredients.

WARNINGS AND PRECAUTIONS

Increase in hematocrit and polycythemia. High red blood cell counts increase the risk of clots, strokes, and heart attacks.

Venous thromboembolic events (VTE). Deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone replacement products like JATENZO.

Benign prostatic hyperplasia (BPH). Patients may see worsening signs and symptoms of BPH.

Prostate cancer. Patients treated with androgens may be at increased risk for prostate cancer.

Blood pressure increases. JATENZO can increase blood pressure. Monitor blood pressure periodically in men using JATENZO. Not recommended for use with uncontrolled hypertension.

Abuse. Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Testosterone abuse can lead to serious cardiovascular and psychiatric adverse reactions.

Suppression of spermatogenesis. Large doses of androgens, like JATENZO, can suppress spermatogenesis.

Hepatic adverse events. JATENZO is not known to cause liver adverse events; however, patients should be instructed to report any signs of hepatic dysfunction.

Retention of sodium and water.

Gynecomastia.

Sleep apnea. Testosterone may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung disease.

Changes in the serum lipid profile may require dose adjustment of lipid-lowering drugs or discontinuation of testosterone therapy.

Risk of hypercalcemia.

ADVERSE EVENTS

The most common adverse events of JATENZO (incidence ≥2%) are headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3%), and nausea (2%).

DRUG INTERACTIONS

JATENZO can cause changes in insulin sensitivity or glycemic control and changes in anticoagulant activity. Use of testosterone and corticosteroids concurrently may increase fluid retention. Use of prescription and nonprescription analgesic cold medications with JATENZO have been known to increase blood pressure.

To report suspected adverse reactions contact Tolmar at 1-844-4TOLMAR (486-5627) or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Please see full Prescribing Information.

References

1. JATENZO® (testosterone undecanoate) capsules, for oral use CIII [package insert]. Fort Collins, CO: Tolmar, Inc.; 2025.

2. Swerdloff RS, Wang C, White WB, et al. A new oral testosterone undecanoate formulation restores testosterone to normal concentrations in hypogonadal men. J Clin Endocrinol Metab. 2020;105(8):2515-2531.

3. Petrova TV, Koh GY. Organ-specific lymphatic vasculature: From development to pathophysiology. J Exp Med. 2018;215(1):35-49.

4. Swerdloff RS, Dudley RE. A new oral testosterone undecanoate therapy comes of age for the treatment of hypogonadal men. Ther Adv Urol. 2020;12:1-16.

5. Data on file. Clinical Study Report: CLAR-15012. Tolmar, Inc.

6. Swerdloff R, Wang C, Longstreth JA, Dudley R, Danoff T. Monitoring testosterone (T) levels in men receiving oral testosterone undecanoate (TU): challenges due to post-collection conversion of TU-to-T and a path forward. Presented at: Endocrine Society Annual Meeting (ENDO 2019); March 23-26, 2019; New Orleans, LA. Abstract SUN-227.2019.

7. Dandona P, Rosenberg MT. A practical guide to male hypogonadism in the primary care setting. Int J Clin Pract. 2010;64:663-664.

8. Lee KK, Berman N, et al. A Simple Self-Report Diary for Assessing Psychosexual Function in Hypogonadal Men. Journal of Andrology. 2003;24(5):688-698.