Kyzatrex Vs. Jatenzo: Better Testosterone Replacement Therapy

Testosterone replacement therapy (TRT) is an important treatment option for men with hypogonadism, a condition where the body does not produce enough testosterone. Two newer TRT medications, Kyzatrex and Jatenzo, provide alternative treatment options to traditional testosterone injections or gels.

This article provides an in-depth comparison of Kyzatrex and Jatenzo, examining the key features, effectiveness, side effects, and other considerations for choosing between these two TRT options.

A Brief Comparison Table

Feature	Kyzatrex	Jatenzo
FDA Approved	No	Yes
Availability	Investigational	Prescription Only
Dosing	213 mg/day	158-237 mg/day
Cost	Not yet set	~$2000-$3000/month without insurance
Delivery Method	Oral capsule	Oral capsule
Key Benefits	– Oral dosing avoids injections</br>- Undergoing clinical trials	– FDA approved</br>- Clinically proven efficacy

Overview Of Kyzatrex And Jatenzo

Kyzatrex (testosterone undecanoate) and Jatenzo (testosterone undecanoate) are relatively new oral TRT capsules approved by the FDA within the last few years. Both medications use a form of testosterone called testosterone undecanoate, which allows for oral administration.

Key similarities between Kyzatrex and Jatenzo:

• Oral testosterone undecanoate capsules taken daily
• Require multiple daily doses (2-3 times per day)
• Bypass first-pass liver metabolism through lymphatic absorption
• Produce stable testosterone levels

However, there are some notable differences:

• FDA Approval – Jatenzo was approved by the FDA in 2019 for hypogonadism treatment. Kyzatrex has not yet been approved by the FDA and is still undergoing clinical trials.
• Dosing – Jatenzo dosing can be adjusted between 158-237mg per day. Kyzatrex has fixed dosing at 213mg per day.
• Cost – Kyzatrex pricing has not been set yet. Jatenzo costs approximately $2,000-$3,000 per month without insurance.

Overall, Kyzatrex and Jatenzo provide oral alternatives to injections or topical testosterone products using similar testosterone undecanoate compounds. But Kyzatrex remains investigational while Jatenzo is FDA-approved, though at a high cost.

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Effectiveness Of Kyzatrex And Jatenzo

Clinical studies have found both Kyzatrex and Jatenzo effective at raising testosterone levels in men with hypogonadism.

In Phase 3 trials of Kyzatrex, average testosterone levels rose from roughly 200 ng/dL at baseline to over 500 ng/dL at 12 weeks. Nearly 90% of men achieved normal testosterone levels. Kyzatrex was effective at maintaining testosterone within the normal range over a year of treatment.

In studies of Jatenzo, testosterone levels increased from around 200 ng/dL at baseline to the mid-to-high 400 ng/dL range within 3-6 weeks. Over 90% of patients attained normal testosterone levels. The effects were durable over a year of continued treatment.

So both Kyzatrex and Jatenzo appear capable of normalizing testosterone levels in hypogonadal men based on clinical trial results. However, direct comparative data between the two drugs is lacking.

Some experts believe oral testosterone undecanoate formulations like Kyzatrex and Jatenzo may be slightly less effective than injectable or transdermal testosterone at raising testosterone levels. But oral capsules avoid the inconvenience and discomfort of injections or gels.

Side Effects Of Kyzatrex And Jatenzo

The safety profiles of Kyzatrex and Jatenzo seem comparable overall. The most common side effects are:

• Acne
• Increased prostate specific antigen (PSA)
• Higher hematocrit (red blood cell percentage)
• Changes in lipids (cholesterol levels)
• Headaches
• Hypertension
• Prostate enlargement

These adverse effects are consistent with other forms of TRT, since raising testosterone levels can cause these issues. There is some evidence Jatenzo may produce fewer hematocrit increases than injectable TRT, but more comparative data is needed.

Importantly, oral testosterone undecanoate has so far demonstrated little to no liver toxicity. It largely avoids the liver via lymphatic absorption. Monitoring liver function is still prudent, however.

Overall, Kyzatrex and Jatenzo share a similar side effect profile with other TRT modalities. However, the long-term safety remains less established compared to older testosterone therapies.

Cost And Availability Of Kyzatrex Vs. Jatenzo

The key differentiation between Kyzatrex and Jatenzo is current availability.

Jatenzo is already FDA approved and commercially available in the United States, though expensive at approximately $2,000-$3,000 per month without insurance coverage. Many insurers still consider it a specialty tier medication. A coupon program provides some cost assistance for patients.

Kyzatrex is not yet FDA approved or commercially available. It is still undergoing Phase 3 clinical trials. The developers, Clarus Therapeutics, plan to submit a New Drug Application to the FDA for approval. Pricing for Kyzatrex has not been set.

So Jatenzo currently has the advantage of being an approved TRT option that physicians can prescribe. But the high cost can make access difficult for some patients. If approved, Kyzatrex could become a potentially cheaper alternative. But that remains pending FDA review.

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Choosing Between Kyzatrex And Jatenzo

For patients already started on Jatenzo, there may be little reason to switch to Kyzatrex in the future unless the latter proves significantly cheaper or more effective.

However, for patients considering starting oral testosterone undecanoate therapy, choosing between Kyzatrex and Jatenzo depends on several factors:

• Insurance Coverage – If Jatenzo is covered, it may be the best option. Kyzatrex may or may not be cheaper out-of-pocket once pricing is set.
• Preference for FDA Approval – Some patients and doctors prefer to choose FDA approved medications like Jatenzo when available.
• Willingness to Change Medications – Starting Jatenzo now means potentially having to switch to Kyzatrex if approved later. The choice depends on one’s comfort with changing medications.
• Timing Needs – Those who need to start TRT urgently may need to begin Jatenzo, while people with less pressing needs could await potential Kyzatrex approval.

Overall, the similarities between the medications make Kyzatrex versus Jatenzo more a matter of availability, access, and cost rather than major differences in efficacy or safety.

Frequently Asked Questions (FAQ)

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Conclusion

In summary, Kyzatrex and Jatenzo offer similar oral testosterone undecanoate therapies for hypogonadism, but currently differ in their FDA approval status and availability. Jatenzo is already approved and on the market, though expensive, while Kyzatrex remains investigational.

Comparative data is limited, but both effectively increase testosterone levels and have similar side effect risks. The choice between Kyzatrex versus Jatenzo depends largely on access, cost factors, and comfort with an unapproved medication for now. But Kyzatrex could shake up the oral testosterone space if it eventually gains FDA approval.