KYZATREX

Peak

testosterone undecanoate

NDAORALCAPSULE
Approved
Jul 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
5

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…

Clinical Trials (5)

NCT03851627Phase 4Recruiting

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
NCT04120363Phase 4Completed

Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations

Started Sep 2019
34 enrolled
Caloric RestrictionExerciseSleep
NCT01346319Phase 1Completed

Study of the Safety, Tolerability and Pharmacokinetics of Testosterone Undecanoate in Hypogonadal Males.

Started Apr 2011
0
Hypogonadal Males
NCT00555087Phase 4Unknown

Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate

Started May 2007
50 enrolled
Erectile DysfunctionHypogonadotrophic Males
NCT00220298Phase 3Completed

Assessment of Long Term Treatment With Testosterone Undecanoate in Males With Hypogonadism

Started Feb 2003
96 enrolled
Hypogonadism

Loss of Exclusivity

LOE Date
Mar 29, 2041
183 months away
Patent Expiry
Mar 29, 2041

Patent Records (5)

Patent #ExpiryTypeUse Code
10576089
Dec 31, 2030
Product
U-2506
10576090
Dec 31, 2030
Product
11590146
Dec 31, 2030
Product
11617758
Mar 15, 2033
Product
U-2506
12357643
Mar 15, 2033
Product
U-2506