KYZATREX (testosterone undecanoate)
Kyzatrex is an oral androgen indicated for testosterone replacement therapy in adult males with conditions associated with a deficiency or absence of endogenous testosterone. This includes primary hypogonadism (congenital or acquired) resulting from testicular failure (e.g., Klinefelter syndrome, chemotherapy, or toxic damage) and hypogonadotropic hypogonadism (congenital or acquired) resulting from hypothalamic or pituitary injury. **Limitations of Use:** Safety and efficacy have not been established in males under 18 years of age or in men with "age-related hypogonadism" (late-onset hypogonadism).
How KYZATREX Works
Kyzatrex delivers testosterone undecanoate, a fatty acid ester of the natural androgen testosterone. Once absorbed, it provides exogenous testosterone to replace deficient endogenous levels. Testosterone and its metabolite, dihydrotestosterone (DHT), bind to specific androgen receptors to promote the maintenance of secondary sex characteristics, including hair distribution, vocal cord thickening, and alterations in muscle mass and fat distribution. In cases of hypogonadism, this exogenous replacement restores serum testosterone concentrations to the normal range.
Details
- Status
- Prescription
- First Approved
- 2022-07-27
- Patent Cliff
- 2041
- Routes
- ORAL
- Dosage Forms
- CAPSULE
KYZATREX Approval History
What KYZATREX Treats
1 indicationsKYZATREX is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypogonadism
KYZATREX Competitive Set
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Indication competitors
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Drugs Similar to KYZATREX
3 of 14FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
19 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03576001 results posted | 2018P001431 R01HD093724-01 | Ph 2 | completed | Multimodality Intervention for Function and Metabolism in SCI |
| NCT05964920 | TESTO-MEM | Ph 2, Ph 3 | completed | Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone? |
| NCT05081193 | J2178 IRB00284702 | Ph 2 | completed | Safety and Efficacy of Oral Testosterone Undecanoate Followed by Enzalutamide as Therapy for Men With Metastatic Castrate Resistant Prostate Cancer |
| NCT03721497 | 2018-002365-19 | Ph 4 | active not recruiting | Testosterone in Bariatric Patients |
| NCT02514629 | CMCS240281 | Ph 3 | completed | Testosterone, Metformin, or Both, for Hypogonadism in Obese Males |
| NCT06489457 SEMAT | SEMA-TESTO Hypogonadism 0120-26/2020/13 | Ph 3 | completed | The Effects of Semaglutide vs Testosterone Replacement Therapy on Functional Hypogonadism and Sperm Quality in Men With Type 2 Diabetes Mellitus and Obesity |
| NCT03851627 Test2Func | T2F12017 2017-001611-37 | Ph 4 | recruiting | Effects of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Overweight/Obese Men With T2DM or Prediabetes and Hypogonadism |
| NCT04120363 OPS II results posted | PBRC 2019-017 W81XWH19C0162, W81XWH19D0010 | Ph 4 | completed | Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations |
| NCT00911586 results posted | CLAR-09009 | Ph 2 | completed | Pharmacokinetic Study to Determine Time to Steady-state |
| NCT04545450 DUTMUSCLE-20 | DUTMUSCLE-20 | Ph 3 | completed | Effects of Testosterone Plus Dutasteride or Placebo on Muscle Strength, Body Composition and Metabolism in Transmen |
| NCT02966652 | DITEST-001 | Ph 1 | completed | Study to Compare DITEST to Testosterone Undecanoate in Adult Men With Hypogonadism |
| NCT03973840 | CLAR-18019 | Ph 1 | completed | Assessment of Blood From Men Receiving Oral TU in Various Collection Tubes |
| NCT03792321 SETH2 | SBCE-KG-2014-1 | Ph 4 | completed | Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2 Diabetic Patients" (SETH2) |
| NCT01206270 ALCeP | 160/10 | Ph 2, Ph 3 | completed | Androgen for Leydig Cell Proliferation |
| NCT01813201 TIC | TIC-0911 2009-016498-13 | Ph 4 | completed | Benefit of the Treatment With Testosterone in Chronic Heart Failure Testosterone Deficiency Subjects |
| NCT03126656 | TECHF001 | Ph 4 | completed | Effects of Testosterone on Myocardial Repolarization |
| NCT01919294 TEREPINS | STH16037 2012-002564-27 | Ph 2 | completed | Testosterone Replacement in Non-alcoholic Steatohepatitis (TEREPINS) |
| NCT01516554 | 38486 812.14 | Ph 2 | terminated | Oral Testosterone for Fatigue in Male Multiple Sclerosis Patients |
| NCT01724658 | CU0115 | Ph 2 | completed | Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
KYZATREX FDA Label Details
Indications & Usage
FDA Label (PDF)KYZATREX is indicated for the treatment of Hypogonadism.
KYZATREX Patents & Exclusivity
Patents (6 active)
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Deep insights for KYZATREX
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2041
- • 54 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 14 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.