Marius Pharmaceuticals and Hims & Hers™ Collaborate to Expand Access to KYZATREX® (testosterone undecanoate) CIII Capsules, the First FDA-Approved Oral Testosterone Therapy Offered on the Hims & Hers Platform

RALEIGH, N.C., Sept. 10, 2025 (GLOBE NEWSWIRE) -- Marius Pharmaceuticals, Inc. today announced a collaboration with Hims & Hers™, one of the largest digital health platforms for men, to make KYZATREX^®, an FDA-approved oral testosterone replacement therapy for adult men with low or no testosterone levels due to certain medical conditions, available to patients through the Hims & Hers platform in the coming months. This marks the first time Hims & Hers will offer an FDA-approved oral testosterone therapy, underscoring KYZATREX’s position as a leader in the testosterone therapy space.

Testosterone deficiency is a common but often underdiagnosed condition that can affect men’s health and quality of life. Traditional care models have not always kept pace with patient needs, with many men facing barriers such as limited awareness, delays in seeing specialists, and fragmented care. By leveraging Hims and Hers’ scale, trusted digital platform, and patient education resources, KYZATREX will now be more accessible than ever to men requiring treatment.

This expanded access is supported by clinical evidence demonstrating the effectiveness of KYZATREX in restoring testosterone levels. In a clinical study, KYZATREX was proven to be up to 96% effective at restoring testosterone levels.^1-3* On average, free testosterone doubled, giving study participants higher amounts of bioavailable testosterone.^2,3 Higher free testosterone levels are generally associated with energy, drive, and performance.⁴ KYZATREX also has a well-established safety profile, offering men and their healthcare providers a proven oral treatment option.¹

*In a six-month clinical trial of 139 men with low testosterone, 88% of patients had normal testosterone levels at Day 90 (worst-case scenario calculation, excluding Site 104). Based on patients who completed the study (n=127), 96% of patients achieved normal testosterone levels at Day 90.

Other key benefits of KYZATREX:

Easy to take
No known liver toxicity¹
Flexible dosing

“This collaboration with Hims & Hers represents an important step forward in addressing the critical need for better access and care for adult men with testosterone deficiency,” said Shalin Shah, CEO of Marius Pharmaceuticals. “By combining KYZATREX, an FDA-approved oral testosterone therapy, with Hims & Hers’ ability to reach and educate millions of men, we are breaking down barriers to care and helping to ensure patients can access innovative treatment in a convenient and trusted way.”

Andrew Dudum, CEO of Hims & Hers added, “At Hims & Hers, our mission has always been to empower people with access to high-quality care and education. Collaborating with Marius to offer KYZATREX, the first FDA-approved oral testosterone therapy on our platform, allows us to continue delivering comprehensive men’s health solutions at scale. This collaboration underscores our commitment to making care more accessible, more personalized, and more effective for patients.”

KYZATREX will be available to patients through the Hims & Hers platform in the coming months as part of a private label partnership between Marius and Hims & Hers.

About Marius Pharmaceuticals
Marius Pharmaceuticals strives to better the lives of patients by focusing on therapies designed for hypogonadism or Testosterone Deficiency. The company's vision is to holistically improve metabolic health and mitigate significant unnecessary costs to the global healthcare system. For more information, please visit www.mariuspharma.com.

About KYZATREX^® (testosterone undecanoate)
KYZATREX is a proprietary softgel oral formulation absorbed primarily via the lymphatic system (meaning it is not toxic to the liver) and indicated in adult males for conditions associated with a deficiency or absence of endogenous testosterone. The safety and efficacy of KYZATREX was demonstrated in a phase 3, multi-center, open-label, six-month study in 155 hypogonadal males between 18 and 65 years of age with documented hypogonadism, as defined by a below normal serum testosterone level (≤281 ng/dL) and at least one sign or symptom of testosterone deficiency. In the efficacy population (n=139), 88 percent of hypogonadal men treated with KYZATREX achieved a mean plasma total testosterone concentration (Cavg) over 24 hours within the normal range (222-800 ng/dL) on the final pharmacokinetic (PK) visit of the study at Day 90 (primary endpoint). Based on exploratory endpoints, patients who received KYZATREX reported improvements in symptoms of low testosterone, including quality of life, energy/fatigue, erectile function, sexual intercourse, and mood. The most common side effect reported in ≥2 percent of KYZATREX patients was increased blood pressure (2.6%). The safety and efficacy of KYZATREX in males less than 18 years old have not been established.

Please see additional Important Safety Information for KYZATREX below or visit www.kyzatrex.com.

What is KYZATREX^®
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.

It is not known if KYZATREX^® is safe or effective in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”).

KYZATREX^® is not meant for use by women.

Important Safety Information for 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); or are allergic to KYZATREX^® or any of its ingredients.

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. Especially, tell your healthcare provider if you take: 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:

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.
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.
Increased risk of prostate cancer.
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.
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 sperm count.
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).
Swelling of your ankles, feet, or body (edema), with or without heart failure.
Enlarged or painful breasts.
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. 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 www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Marius [by visiting www.mariuspharma.com].

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

See Full Prescribing Information and Medication Guide for KYZATREX^®.

References:

KYZATREX [prescribing information]. Raleigh, NC: Marius Pharmaceuticals; 2025.
Bernstein JS, Dhingra OP. A phase III, single-arm, 6-month trial of a wide-dose range oral testosterone undecanoate product. Therapeutic Advances in Urology. 2024;16. doi:10.1177/17562872241241864
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. Accessed 9 Feb. 2024.

Media Contact:
Lilly Washburn
lilly@mariuspharma.com

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