Monday, April 7, 2025

Testosterone Therapy Now Comes in a Pill? FDA Approves Oral TRT Options for Men With Low T

Comparing Oral Testosterone Therapies. 

Kyzatrex and Jatenzo. Whats Better for Men on TRT?

 

FDA Approved Oral Testosterone for Men on TRT

For men with low T, starting TRT can be a difficult decisions. For those men dealing with the challenges of low testosterone, Testosterone Replacement Therapy or TRT as it's commonly called, has emerged as an effective and safe treatment option, significantly improving both quality of life and overall health. Typically, TRT administration involves standard methods such as injectable testosterone like cypionate and enanthate, topical creams and gels. As a clinic its important to understand that these routes may not align with every one of your patient's choice or best interest. The important thing is making sure that your patient is comfortable with their protocol in order for them to best adhere to the physicians instructions, which will increase the likelihood of a successful course of treatment. The production of FDA-approved oral testosterone pills creates a more user-friendly option for many men. Two of the more famous examples are Kyzantrex and Jatenzo which are both oral pills used in testosterone replacement therapies and both have FDA approval, which is excellent news. 



 

FDA Approved Oral Testosterone 

FDA Endorses Oral Testosterone Options for Hypogonadism

The pharmaceutical landscape for treating adult men with hypogonadism has expanded with the FDA's approval of oral testosterone replacement therapies, namely Kyzatrex and Jatenzo. Jatenzo marked a significant advancement in Hormone Replacement Therapy (HRT) when it was approved by the FDA in March of 2019, offering a less invasive and more convenient option compared to traditional methods like injections, pellets, patches, and gels. Subsequently, Kyzatrex, developed by Marius Pharmaceuticals, gained FDA approval in August 2022. Many clinicians and patients view Kyzatrex as an improved formulation over Jatenzo, engineered for optimized absorption and sustained testosterone levels. The FDA's endorsement of both medications followed rigorous clinical trials, confirming their efficacy in normalizing testosterone levels within a safe and acceptable profile.



The introduction of Kyzatrex and Jatenzo represents a significant leap forward in oral TRT, especially given past safety issues. Previously, doctors generally steered clear of oral testosterone due to the considerable dangers of older versions. These earlier drugs, like methyltestosterone, were heavily processed by the liver, often causing liver damage ranging from mild strain to severe conditions like tumors and cholestasis. Because of these high risks and potential side effects, physicians preferred prescribing testosterone injections or skin gels. However, Kyzatrex and Jatenzo, the newer oral options, are specifically designed to bypass the liver by being absorbed through the lymphatic system. This dramatically reduces the risk of liver toxicity, making oral TRT a much safer and now practical treatment choice for doctors and their patients.

 


How do testosterone pills work? 

 


For men with hypogonadism, a state of insufficient testosterone production, Kyzantrex and Jatenzo offer oral routes to restore hormone levels within the clinically recommended range. Because low testosterone can stem from various factors, a thorough medical assessment and diagnosis are paramount before starting any therapy.

Although both are oral treatments, their specific ways of working and how they are made differ noticeably, requiring careful discussion between a doctor and patient before a prescription is written.

Jatenzo comes as an oral capsule containing testosterone undecanoate, a long-chain form of testosterone. It's primarily absorbed via the lymphatic system, which reduces its passage through the liver and first-pass metabolism. This absorption method effectively avoids the liver issues linked to older oral testosterone. Jatenzo is usually taken twice a day and should be consumed with food, especially meals high in fat, to maximize its uptake. Once swallowed, the testosterone undecanoate breaks down, releasing active testosterone into the bloodstream.

Kyzantrex also contains testosterone undecanoate for oral use but is a soft gel capsule, unlike Jatenzo. Kyzantrex uses a self-emulsifying system to improve its absorption into the lymphatic system, similar to Jatenzo. It's also taken twice daily with food. The soft gel capsules are designed to dissolve quickly, and the overall formulation aims to boost bioavailability, leading to a more stable and predictable rate at which testosterone is absorbed into the body.

Importantly, food intake significantly boosts the absorption of both Kyzantrex and Jatenzo. Therefore, strictly following the prescribed dosage and dietary guidelines, particularly regarding fat consumption, is essential, as insufficient fat intake can greatly reduce how much of each medication the body absorbs. Despite sharing the same active ingredient and general mechanism, Kyzantrex is often thought to have a formulation that provides a more consistent pharmacokinetic profile, potentially resulting in more stable hormone balance and testosterone levels throughout the day.

 

What are the benefits of oral testosterone?

The arrival of oral TRT choices like Kyzatrex and Jatenzo effectively resolves several common issues tied to traditional TRT delivery methods.

Greater Ease of Use: Patient care often involves teaching and assisting men with self-administering injectable testosterone, such as testosterone cypionate or enanthate  . Many men are unfamiliar with giving injections and need detailed guidance on handling the medication and the injection process itself. However, oral TRT inherently simplifies this. Since most men already know how to swallow pills, this method is especially attractive to those who dislike needles or want to avoid regular weekly clinic visits for shots. These individuals often find the simplicity of taking a pill very beneficial. While Transdermal testosterone gels are non-invasive, some patients find them inconvenient and worry about transferring the medication to others or pets through skin contact. Similarly, although patches are easy to use, they can irritate the skin with prolonged wear and might be noticeable. On the other hand, oral TRT capsules are more portable and eliminate the need to refrigerate additional medications like  HCG or the logistical challenges of traveling with syringes. As a result, swallowing a capsule is a simple and convenient way to start TRT, free from the risks, complexities, or anxieties associated with other delivery systems.


 

 


 

More Even Hormone Levels:

Kyzantrex and Jatenzo provide the benefit of more consistent testosterone levels throughout the day, helping to avoid the hormone swings frequently observed with traditional injectable TRT. Injectable testosterone, like cypionate or enanthate, has a longer duration, usually requiring weekly doses due to their roughly week-long half-life. After an injection, testosterone levels significantly spike and then gradually decrease over the following days, creating cyclical highs and lows. These fluctuations can lead to mood swings, irritability, and difficulty managing symptoms or side effects for some. Conversely, oral testosterone medication, when taken regularly with food, shows a very predictable pattern in the body, resulting in more stable hormone levels. Kyzatrex, with its enhanced delivery, may offer an even greater advantage in achieving smoother and more balanced testosterone levels, potentially helping to reduce mood variability and promote consistent energy and less fatigue with regular use.

Eliminating Injection Worries for TRT Patients:

For some men, the idea of self-injection causes significant anxiety and fear related to needle discomfort, a condition called trypanophobia. This fear can be a major barrier to starting or sticking with TRT. The anxiety around needles can trigger intense psychological distress, including panic attacks and feelings of helplessness, leading to physical responses like sweating, rapid heartbeat, dizziness, nausea, or even fainting. For certain TRT patients, just thinking about self-injection can cause considerable emotional discomfort, reinforcing avoidance and increasing anxiety about medical treatments, potentially leading them to stop treatment without consulting a doctor and experience a return of low testosterone symptoms, despite the availability of better delivery options.

Another potential problem with injectable testosterone is a higher risk of erythrocytosis, an increase in red blood cell count. While oral testosterone isn't entirely without this risk, it's thought that the more stable hormone levels achieved with oral forms might help reduce the significant spikes in red blood cell production often linked to the fluctuating levels seen with injections.




Choosing Between Kyzantrex and Jatenzo: What's Best for You?

Deciding whether Kyzantrex or Jatenzo is the right oral TRT option isn't straightforward, and neither is definitively superior. The ideal choice often depends on a patient's individual medical background, a doctor's professional advice, and how well the patient tolerates the medication. Several factors come into play.

A crucial consideration is how well a patient tolerates the drug and the specific side effects they experience. Similar to how people have different preferences for over-the-counter pain relievers, individual physical reactions to Kyzantrex or Jatenzo can vary.

While both medications share potential side effects like increased red blood cell count, possible blood pressure increases, and changes in cholesterol, some patients may find one more tolerable than the other. Clinical studies have confirmed that both effectively normalize testosterone levels. However, slight differences in how they are absorbed and an individual's ability to absorb and process the medication can affect the specific side effects encountered.

Some men have reported a more stable and consistent hormonal experience with Kyzantrex, noticing fewer mood swings, which might be related to its unique way of being absorbed. On the other hand, other patients find Jatenzo equally effective and better tolerated, especially with longer use as their bodies adjust.

A healthcare professional specializing in hormone replacement therapy, particularly TRT and these oral forms, can offer invaluable guidance based on patient experiences and clinical results, highlighting the importance of consulting an experienced doctor for any medical advice or treatment.

In conclusion, both Kyzantrex and Jatenzo mark significant advancements in testosterone replacement therapy, offering more men effective, needle-free ways to achieve hormone balance, better health, and an improved quality of life. While they are similar in how they work and are taken, Kyzantrex's delivery method seems to offer a slight benefit in absorption consistency for some. Ultimately, the final choice depends on individual preference and how well each medication is tolerated. If a patient has negative side effects with one, their doctor might suggest switching to the other. For many, the main appeal of oral testosterone is its convenience, discretion, and avoidance of injections or gels, which, despite being effective, also have their drawbacks. As oral testosterone therapy continues to develop, it's becoming an increasingly preferred option, allowing men to manage their low testosterone with greater ease and confidence.




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