Multi-centre study of Jatenzo shows treatment is effective in long-term use in testosterone deficiency.- Clarus Therapeutics

Clarus Therapeutics Inc. announced positive results of an open-label, multi-center safety and efficacy analysis following two years of Jatenzo (testosterone undecanoate) oral capsules use in hypogonadal men. The data supports Jatenzo as an effective long-term testosterone replacement therapy (TRT), with no evidence of liver toxicity.The two-part study evaluated two years of twice-daily Jatenzo use in hypogonadal men (two serum T below 300 ng/dL) aged 18-75 years. The first study followed patients for 12 months; 86 men from the first study then enrolled in the second study, which lasted another year. The analysis found that Jatenzo use kept total testosterone levels in the normal range with a safety profile that is relatively consistent with other forms of TRT. It also demonstrated no clinically significant change in liver function tests – no clinically significant changes in alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine transaminases (ALT), and bilirubin levels. It showed small, yet statistically significant, increases in prostate-specific antigen (PSA), a protein produced by the prostate, and hematocrit (HCT), which measures red blood cell levels. These increases are observed with other TRTs, regardless of mode of administration, and had minimal effects on LDL ("bad") cholesterol and lowered HDL ("good") cholesterol, which is common among other TRTs. Results were presented virtually at ENDO 2021, the Endocrine Society's annual meeting.