NDAORALCAPSULE
Approved
Jul 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
10
Data completeness
5/8 — Partial
KYZATREX (testosterone undecanoate) by Marius Pharmaceuticals is androgens, including testosterone and dihydrotestosterone (dht), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. First approved in 2022.
Drug data last refreshed 21h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KYZATREX is an oral testosterone undecanoate capsule approved in 2022 for male hypogonadism, a condition caused by insufficient testosterone production from either gonadal defects (primary) or hypothalamic/pituitary failure (secondary). It works by replacing or supplementing testosterone and its active metabolite DHT to restore normal sexual function, secondary sex characteristics, and metabolic health in deficient males.
Peak14.5 years to LOE
Product is at peak sales phase post-launch with strong patent protection; commercial team focus is on market expansion and competitive positioning in oral testosterone replacement.
Mechanism of Action
androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis, and scrotum; the…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (10)
Effects of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Overweight/Obese Men With T2DM or Prediabetes and Hypogonadism
Started Jan 2022
32 enrolled
Fatty LiverOverweight/ObesityPrediabetes/Type2 Diabetes Mellitus+1 more
Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations
Started Sep 2019
34 enrolled
Caloric RestrictionExerciseSleep
Ambulatory Blood Pressure Monitoring (ABPM) Extension Study of Oral Testosterone Undecanoate in Hypogonadal Men
Started Sep 2018
155 enrolled
Hypogonadism, Male
Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men
Started Jul 2017
314 enrolled
Hypogonadism, Male
Study to Compare DITEST to Testosterone Undecanoate in Adult Men With Hypogonadism
Started Nov 2016
25 enrolled
Male Hypogonadism
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.