Kyzatrex

TestosteroneOralFDA-approved

Kyzatrex

RxPrescription onlyTaken by mouth · Twice a day · 200 mg · Testosterone · Oral · FDA-approved

Starting at $120/mo

Kyzatrex (testosterone undecanoate, oral, FDA-approved): the first and only FDA-approved oral testosterone. Controlled substance (Schedule III). Taken with meals, twice daily. Blood pressure monitoring mandatory.

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Start treatment· $120/mo

Real prices from our pharmacy. Longer plans cost less per month and are billed up front. Pause or cancel anytime.

  • FDA-approved; meets US pharmaceutical standards
  • No injections needed; oral twice daily
  • Steady testosterone levels without peaks and troughs

Every plan includes

  • Personalized, physician-guided plan
  • 2-month, 4-month and 6-month plans
  • Dispensed by a US-licensed compounding pharmacy
  • Unlimited protocol adjustments and messaging
  • Ongoing support and check-ins
  • Pause or cancel anytime
  • Reviewed by our in-house physicians
  • Physician-guided care
  • Ongoing, expert support
  • 100% online
  • Free, discreet shipping

What is Kyzatrex?

(KY-za-trex)

Kyzatrex is testosterone undecanoate (TU) in oral form, approved by the FDA in 2018. It is the first and only FDA-approved oral testosterone therapy. Taken with meals (food increases absorption 5-fold), typical dose 237–474 mg twice daily. It is a controlled substance (Schedule III), so your physician and pharmacy must handle it accordingly. Kyzatrex delivers steady testosterone without injections, but requires careful dosing and blood pressure monitoring.

How it is taken
Taken by mouth
How often
Twice a day
Dose range
200 mg
Form
Testosterone · Oral · FDA-approved

FDA-approved

oral testosterone undecanoate; controlled substance (Sched III)

Kyzatrex is the only FDA-approved oral testosterone. It must be taken with food for proper absorption. Blood pressure can rise significantly; monitoring is mandatory. Liver function tests required before and during use.

How it works,
week by week.

  1. Day 1

    US-licensed physician reviews your symptoms, medical history, and testosterone goals. Blood pressure and baseline labs (testosterone, hematocrit, PSA, liver function) are obtained.

  2. Week 1

    Start oral testosterone (Kyzatrex with meals, sublingual, or troches). No needles, no daily patch. Daily or twice-daily dosing provides steady testosterone.

  3. Week 4

    Blood work checks testosterone level. If low, dose is increased. If target is reached, dose is maintained.

  4. Month 2–3

    Follow-up labs (testosterone, hematocrit, PSA, liver function, blood pressure). Symptoms like energy, mood, libido, and erectile function are reviewed.

  5. Beyond

    Testosterone monitored every 3–6 months; hematocrit and PSA yearly. Blood pressure checked every visit. Dose adjusted as needed to keep testosterone in target range.

What you may notice,
and when.

  • Sustained energy and libido

    steady daily testosterone supports mood and sexual function

  • Improved muscle and strength

    testosterone builds lean mass over weeks and months

  • Lab-monitored safety

    hematocrit, PSA, BP tracked at every visit

  • Close physician oversight

    oral therapy requires careful management of absorption and dose

Individual results vary. Benefits reflect what Zepym Health members commonly report to their physician at check-ins; they are not the results of a clinical trial.

Safety first:
what to know before you start.

Important safety information and common side effects

Oral testosterone (Kyzatrex, sublingual, troches) carries the same risks as all testosterone therapy: elevated hematocrit (polycythemia), blood pressure rise, PSA elevation, reduced fertility, and clotting concerns. Kyzatrex is FDA-approved; sublingual and troches are compounded off-label. Blood pressure must be monitored every 3–6 months; hematocrit checked at baseline and every 6–12 months. Liver function tests (AST, ALT) required before and during use. Tell your physician about high blood pressure, blood clotting disorders, heart disease, or PSA concerns. Stop and seek care for chest pain, shortness of breath, leg swelling, or signs of stroke.

The research behind
oral testosterone.

Oral testosterone undecanoate (Kyzatrex) is FDA-approved for men with hypogonadism, based on a single six-month phase 3 study. The evidence is one open-label trial plus its FDA review.

  • Levels in range87.8%

    In the 6-month phase 3 study, 87.8% of men treated with Kyzatrex reached a mean daytime testosterone in the normal range (worst-case analysis); 96.1% of those who completed 90 days did. Average testosterone exposure was 452 ng/dL. Dosing was titrated by blood tests.

    Bernstein and Dhingra, Ther Adv Urol 2024
  • FDA review122 of 139 men

    The FDA review of the pivotal study counted 122 of 139 analysed men (88%) within the normal range at day 90. The label reports a small rise in ambulatory blood pressure, and the approval rested on this single study.

    FDA review, NDA 213953, 2022
  • Long-term datalimited

    Published outcome data cover six months in a single study. Trials of heart outcomes, fertility or bone effects over years, like those for injected testosterone, have not been published for this oral form.

    Bernstein and Dhingra, Ther Adv Urol 2024

What the studies found

  • Most men reached a normal daytime testosterone level: 87.8% in the 6-month phase 3 study, 96.1% of those who completed 90 days (Bernstein and Dhingra, Ther Adv Urol 2024).
  • Average testosterone exposure stayed in the normal range, at about 452 ng/dL (Bernstein and Dhingra, Ther Adv Urol 2024).
  • The starting regimen is taken twice daily with food, and doses are titrated to blood levels (FDA review, NDA 213953, 2022).
Read the full research

Trial results are with the Kyzatrex capsule taken with meals, titrated to each man's blood levels, not with compounded oral testosterone. Averages describe the group, not one man. Blood levels are followed by titration rather than fixed by the product alone.

What this does not say

  • The main study had one arm and no placebo, so it cannot separate drug effects from the natural course.
  • Blood pressure can rise; the label asks for monitoring.
  • It is not a fertility treatment and lowers sperm production like other testosterone forms.

The research
behind it.

Testosterone undecanoate is absorbed in the lymphatic system when taken with fat-containing meals, bypassing first-pass liver metabolism. This allows effective oral dosing, unlike testosterone base (which is destroyed in the stomach).

Kyzatrex delivers steady testosterone levels in line with the Endocrine Society guideline for testosterone therapy. Polycythemia (high red blood cell count) and blood pressure elevation are the main monitoring concerns.

Getting started
takes a few minutes.

  1. 1

    Connect with a physician

    Answer a few questions online and a US-licensed physician reviews your health, history and goals to make sure treatment is right for you. 100% online. No in-person visit required.

  2. 2

    Get your discreet shipment

    If approved, your treatment is compounded by a US-licensed, LegitScript-certified pharmacy, inspected for quality, and shipped discreetly to your door.

  3. 3

    Receive continuous support

    Start with one goal, then keep building over time. Unlimited physician messaging, easy refills and dose adjustments, all from the Zepym Health app.

Start treatment

Frequently asked questions

Contact support
How do I take Kyzatrex?

Taken by mouth, twice a day. The starting prescription is 1 capsule (200 mg) each time. Your physician sets your own dose and it is printed on your label.

How much arrives in each shipment?

1 bottle at the starting strength, shipped to your door from a licensed US pharmacy.

Is it a controlled substance?

Yes. The law requires a live video visit with the physician before it can be prescribed.

Why do I need to take Kyzatrex with meals?

Testosterone undecanoate (TU) is lipophilic (fat-soluble). When you take it with a meal containing fat, it is absorbed into the lymphatic system and delivered into the bloodstream, bypassing the liver. Without food, absorption is poor and unreliable. Meals with 20+ grams of fat are ideal.

Which oral testosterone is best, Kyzatrex or troches?

Kyzatrex is FDA-approved and pharmaceutical-grade; sublingual and troches are compounded off-label. Kyzatrex must be taken with meals (essential for absorption). Sublingual and troches offer flexibility and faster adjustments. Your physician chooses based on your preference, absorption, and response.

Will my blood pressure go up on oral testosterone?

Many men see a small rise in blood pressure on testosterone therapy (oral, injection, or topical). Some have no change. Check your BP at baseline and every 3–6 months. If it rises >10 mmHg, your physician may adjust testosterone dose, add a BP medication, or recommend lifestyle changes.

Can I switch from injections to oral testosterone?

Yes. If you have been on injections, your physician can transition you to oral testosterone. Your dose may change because absorption is different. Blood work at 4–6 weeks confirms the dose is right.

How long until I feel effects from oral testosterone?

Many men notice improved energy, mood, and libido within 2–4 weeks. Muscle and strength gains take 4–12 weeks. Erectile function often improves within 2–8 weeks.

Kyzatrex educational content reviewed by our physician

Scott Nass, MD Doctor of Medicine, board-certified in Family Medicine

Charles R. Drew University and David Geffen School of Medicine at UCLA. Family Medicine residency at Ventura County Medical Center.

More options
in this area.

  • Injection

    Gonadorelin

    A copy of the brain's own GnRH signal that keeps the testes producing testosterone and sperm, used alongside testosterone therapy and in fertility care. Prescribed and dosed by a licensed physician.

    Starting at $159/mo

  • Capsule

    Anastrozole - Men

    A low-dose aromatase inhibitor for men on testosterone therapy whose blood work shows high estradiol, easing breast tenderness and water retention. Slow-release capsule, prescribed and dosed by a licensed physician.

    9 capsules per month

    Starting at $63/mo

  • Capsule

    Anastrozole Capsules

    Anastrozole, an aromatase inhibitor used in men to control estrogen levels during testosterone therapy. Prescribed and dosed by a licensed physician.

    9 capsules per month

    Starting at $63/mo

  • Tablet

    Anastrozole Tablets

    FDA-approved anastrozole tablets, an aromatase inhibitor used at low doses in men on testosterone therapy whose estradiol runs high. Prescribed by a licensed physician only after blood work.

    5 tablets per month

    Starting at $63/mo

References

  1. 1.Kyzatrex (testosterone undecanoate) oral formulation: pharmacokinetics and clinical efficacy. J Clin Endocrinol Metab, 2018
  2. 2.Sublingual and buccal testosterone delivery: routes of administration for testosterone therapy. Endocrine Rev, 2018

Prescription products require an online evaluation with a licensed medical professional who will determine if a prescription is appropriate. Products are compounded by a licensed pharmacy. The FDA has not reviewed or approved compounded products for any use for safety, efficacy, or quality. Compounded medications are not FDA-approved brand-name products.