For decades, men with clinically low testosterone faced a narrow set of options: needles, gels that could rub off on family members, or older oral pills that damaged the liver. That changed starting in 2019, when the FDA approved the first of three oral testosterone undecanoate formulations — Jatenzo, followed by Tlando and Kyzatrex — that bypass the liver entirely by absorbing through the intestinal lymphatic system. These are not your father’s testosterone pills. They work, they appear to be cardiovascular-safe based on the largest trial ever conducted on the question, and as of February 2025, the FDA has removed the long-standing black box warning about heart risk from all testosterone products. For readers of this site who track brain health and cognitive decline, this matters more than it might seem.
Testosterone levels have long been studied in connection with dementia risk, cognitive function, and mood regulation in aging men. Hypogonadism — the clinical condition these drugs treat — is associated with fatigue, depression, and cognitive fog, symptoms that overlap with and can complicate early dementia assessment. Having a safe, effective oral option changes the calculus for men and their doctors when weighing treatment. This article covers how these three FDA-approved oral formulations actually differ from each other, the landmark TRAVERSE trial that rewrote the safety narrative, new accessibility through telehealth platforms like Hims, and the practical tradeoffs between oral testosterone and injections or gels. We will also address what these drugs are not approved for — and why that distinction matters.
Table of Contents
- What Makes FDA-Approved Oral Testosterone Different from Past Formulations?
- The TRAVERSE Trial Changed the Safety Conversation
- Comparing the Three Approved Oral Formulations
- How Oral Testosterone Compares to Injections and Gels
- New Telehealth Access Through Hims and Pricing Realities
- The Brain Health Connection That Often Gets Overlooked
- Where Oral Testosterone Goes from Here
- Conclusion
- Frequently Asked Questions
What Makes FDA-Approved Oral Testosterone Different from Past Formulations?
The reason oral testosterone was avoided for decades comes down to one organ: the liver. Earlier oral formulations like methyltestosterone were processed through first-pass hepatic metabolism, meaning the drug passed through the liver before reaching the bloodstream. This caused hepatotoxicity — liver damage — and in some cases, liver tumors. Doctors rightly steered patients away from oral testosterone and toward injections or topical gels. Jatenzo, Tlando, and Kyzatrex all use testosterone undecanoate, an ester formulation designed to be absorbed through the lymphatic system in the intestines rather than the portal vein that feeds directly into the liver. When taken with food — especially a meal containing some fat — these capsules enter the bloodstream via lymphatic channels, effectively sidestepping the liver problem that plagued older oral options. This is not a minor pharmacological tweak.
It is the reason oral testosterone went from being considered dangerous to earning FDA approval three times over. The efficacy numbers back this up. Kyzatrex brought 96 percent of patients into the therapeutic testosterone range of 300 to 1,000 ng/dL after 90 days, well above the FDA’s 75 percent approval threshold. Jatenzo achieved 83.6 percent at 90 days and held at 85 percent after a full year. Tlando came in at 80 percent with a simpler fixed-dose approach that eliminates the need for titration. These are not marginal results. For a condition where men previously had to tolerate injections or messy gels, having a twice-daily capsule that works this reliably is a genuine shift.
The TRAVERSE Trial Changed the Safety Conversation
The biggest cloud hanging over testosterone replacement therapy for years was cardiovascular risk. In 2015, the FDA added a black box warning to all testosterone products, cautioning about increased risk of heart attacks and strokes. For men already managing heart disease — which overlaps heavily with the population most likely to have low testosterone — this warning made many physicians reluctant to prescribe. The TRAVERSE trial was designed to answer the question definitively. It enrolled 5,204 men aged 45 to 80, all of whom had either preexisting cardiovascular disease or were at high risk for it, along with hypogonadism symptoms and fasting testosterone levels below 300 ng/dL. This was not a study of healthy young men. These were exactly the patients doctors worried most about.
After years of follow-up, cardiovascular events occurred in 7.0 percent of the testosterone group compared to 7.3 percent of the placebo group — a hazard ratio of 0.96 with a confidence interval that confirmed noninferiority. In plain language, testosterone therapy was not worse than doing nothing when it came to major cardiac events. However, the story is not entirely clean. While the FDA removed the black box warning in February 2025 based on TRAVERSE data, the agency simultaneously added new labeling requirements warning about increased blood pressure. Postmarket ambulatory blood pressure monitoring studies showed that all testosterone products — regardless of whether they are oral, injectable, or topical — raise blood pressure. For men already managing hypertension, this is a real concern that needs active monitoring. The cardiac scare may be over, but blood pressure management just became a more prominent part of the treatment conversation.
Comparing the Three Approved Oral Formulations
Not all three oral testosterone undecanoate products are interchangeable, and the differences matter depending on a patient’s needs and preferences. Kyzatrex, manufactured by Marius Pharmaceuticals, posted the strongest efficacy numbers at 96 percent and showed more favorable hypertension data compared to Jatenzo and Tlando in clinical trials. It comes in 100 mg, 150 mg, and 200 mg capsules, allowing doctors to individualize dosing. On average, it doubles free testosterone levels — the bioavailable form that actually drives physiological effects. Jatenzo was the first to market in March 2019 and also offers individualized dosing.
Its 83.6 percent efficacy rate at 90 days is strong, and the 85 percent sustained response at one year provides reassurance about long-term reliability. Tlando takes a different approach entirely: fixed dosing with no titration required. Its 80 percent efficacy rate still exceeds the FDA’s threshold, and the simplicity of a one-size regimen appeals to both patients and prescribers who want fewer follow-up adjustments. All three carry shared safety concerns, including risks of polycythemia (an elevation in red blood cell count that can increase clotting risk), lipid changes, and the blood pressure effects noted above. The choice between them often comes down to whether a patient and their physician prioritize peak efficacy numbers, dosing simplicity, or the most favorable side effect profile. For older men whose medical picture includes cognitive concerns alongside low testosterone, the conversation should involve both an endocrinologist or urologist and whoever is managing their broader neurological care.
How Oral Testosterone Compares to Injections and Gels
The practical differences between oral capsules, injections, and topical gels go beyond convenience, though convenience matters too. Injectable testosterone — typically administered every one to four weeks — produces a hormonal roller coaster. Testosterone levels spike shortly after injection, then gradually decline until the next dose. These peaks and troughs can affect mood, energy, and cognitive clarity in ways that are particularly disruptive for men already dealing with neurological vulnerabilities. Oral testosterone undecanoate taken twice daily with meals produces more stable testosterone levels throughout the day. There are no needles and no injection-site reactions. Compared to gels, oral formulations eliminate the risk of transference — the accidental exposure of partners, children, or pets to testosterone through skin contact.
Transference is not a theoretical concern. The FDA has issued warnings about children developing premature puberty symptoms after contact with adults using testosterone gels. For men living with family members or caregivers, oral dosing removes that variable entirely. The tradeoff is adherence. Twice-daily dosing with food is more demanding than a biweekly injection or a once-daily gel application. Missing doses or taking capsules on an empty stomach reduces absorption significantly, since the lymphatic uptake pathway depends on dietary fat. For men with cognitive impairment or executive function challenges — a population this site’s readers know well — pill management may require caregiver involvement or a structured medication routine to maintain effectiveness.
New Telehealth Access Through Hims and Pricing Realities
In 2026, Hims and Hers Health announced an exclusive collaboration with Marius Pharmaceuticals to offer branded Kyzatrex through their telehealth platform. This is significant because the retail price of oral testosterone undecanoate runs between $400 and $1,700 per month without discount programs — a cost that puts it out of reach for many men, particularly those on fixed incomes or Medicare. Through Hims, Kyzatrex pricing drops to approximately $199 per month on a three-month plan, $139 per month on a five-month plan, or $99 per month on a ten-month commitment. Hims will also be introducing injectable testosterone treatments in 2026, giving patients multiple options through a single platform. The telehealth model offers convenience, but it raises a legitimate concern: testosterone replacement therapy requires blood work, monitoring of hematocrit levels, and blood pressure tracking.
Men considering this route should confirm that their telehealth provider includes lab monitoring as part of the program, not just prescription fulfillment. A critical limitation applies to all three FDA-approved oral formulations. They are approved exclusively for men with hypogonadism caused by specific medical conditions — such as pituitary disorders, Klinefelter syndrome, or damage to the testes. They are not approved for age-related testosterone decline, which is a normal part of aging. Prescribing testosterone to men whose levels drop naturally with age remains off-label and controversial, particularly because the long-term effects of supplementation in this population have not been studied with the same rigor as the TRAVERSE trial provided for true hypogonadism.
The Brain Health Connection That Often Gets Overlooked
Research on testosterone and cognitive function has produced mixed but intriguing results over the years. Some studies suggest that low testosterone is associated with increased risk of Alzheimer’s disease and that replacement therapy may improve verbal memory and spatial reasoning in hypogonadal men. Others have found no clear cognitive benefit.
What is less ambiguous is that the symptoms of untreated hypogonadism — persistent fatigue, depressed mood, poor concentration, and sleep disruption — can mimic or worsen early cognitive decline, making accurate diagnosis harder. For families navigating a dementia evaluation, undiagnosed low testosterone in a male patient can be a confounding variable. If a man presents with memory complaints, low energy, and mood changes, checking testosterone levels is a reasonable step before attributing everything to neurodegeneration. Having an oral treatment option that avoids the peaks and troughs of injections and the transference risks of gels makes it easier for caregivers to manage one more piece of a complicated medical picture.
Where Oral Testosterone Goes from Here
The removal of the cardiovascular black box warning, combined with expanded access through telehealth and more competitive pricing, suggests that oral testosterone is moving toward broader clinical adoption. The next several years will likely produce more real-world data on long-term outcomes, particularly around blood pressure effects and polycythemia rates outside of controlled trial settings. For the dementia care community, the more interesting question is whether the stabilization of testosterone levels through oral dosing translates into measurable cognitive or mood benefits compared to injections.
That data does not exist yet. But the infrastructure — safe oral formulations, a resolved cardiac safety question, and accessible pricing — is now in place for those studies to happen. In the meantime, men with diagnosed hypogonadism and their care teams have meaningfully better options than they did even five years ago.
Conclusion
The FDA approval of three oral testosterone undecanoate formulations — Jatenzo, Tlando, and Kyzatrex — represents a genuine advance in how hypogonadism is treated. The lymphatic absorption pathway that bypasses liver toxicity, efficacy rates between 80 and 96 percent, and the landmark TRAVERSE trial showing cardiovascular noninferiority have collectively dismantled the main barriers that kept oral testosterone off the table for decades. The removal of the black box warning in February 2025 formalized what the data showed. What has not changed is the need for medical oversight.
These drugs carry real risks including elevated blood pressure, polycythemia, and lipid disruption. They are approved for a specific medical condition, not for the general fatigue that accompanies aging. For men in the dementia care ecosystem — whether as patients or as aging partners of those receiving care — oral testosterone is worth discussing with a physician if low testosterone is suspected. It is not a cognitive cure, but untreated hypogonadism makes everything harder, and treating it just became meaningfully simpler.
Frequently Asked Questions
Is oral testosterone safe for older men with heart disease?
The TRAVERSE trial, which specifically enrolled men aged 45 to 80 with preexisting or high-risk cardiovascular disease, found that testosterone therapy was not worse than placebo for major cardiac events. The FDA removed the black box cardiovascular warning in February 2025 based on this data. However, all testosterone products now carry warnings about increased blood pressure, which requires monitoring.
Can I get oral testosterone for age-related low testosterone?
The three FDA-approved oral formulations are approved only for hypogonadism caused by specific medical conditions, not for the natural decline in testosterone that occurs with aging. Using them for age-related decline is off-label and not supported by the same level of clinical evidence.
How much does oral testosterone cost without insurance?
Retail prices for oral testosterone undecanoate range from $400 to $1,700 per month without discount programs. Through the Hims telehealth platform, Kyzatrex is available starting at approximately $99 per month on a 10-month plan, with higher monthly costs for shorter commitments.
Do I have to take oral testosterone with food?
Yes. All three formulations rely on absorption through the intestinal lymphatic system, which requires dietary fat to work effectively. Taking capsules on an empty stomach significantly reduces absorption and efficacy. A meal containing some fat is recommended at each dose.
Does oral testosterone help with memory or cognitive decline?
Research on testosterone and cognition remains mixed. Some studies suggest potential benefits for verbal memory and spatial reasoning in hypogonadal men, but results are inconsistent. What is clearer is that untreated hypogonadism causes fatigue, mood changes, and concentration problems that can mimic or worsen cognitive decline, making proper diagnosis and treatment important.
What is the difference between Jatenzo, Tlando, and Kyzatrex?
All three are oral testosterone undecanoate capsules using lymphatic absorption. Kyzatrex showed the highest efficacy at 96 percent and more favorable blood pressure data. Jatenzo was first to market with 83.6 percent efficacy and strong one-year durability. Tlando offers a simpler fixed-dose regimen at 80 percent efficacy, requiring no dose adjustments.
