NORTHBROOK, Ill.—Clarus Therapeutics Inc. announced today that Jatenzo (testosterone undecanoate) capsules are now available by prescription in the U.S. for the treatment of appropriate men with testosterone deficiency (hypogonadism). Jatenzo is reportedly the first and only oral softgel testosterone undecanoate, and the first oral testosterone medicine approved by the U.S. Food and Drug Administration (FDA) in more than 60 years.
“Jatenzo is finally available to healthcare providers and their hypogonadal patients,” said Dr. Robert Dudley, chief executive officer of Clarus Therapeutics. “This FDA-approved oral testosterone replacement option is an important addition to the treatment landscape for men with testosterone deficiency. We believe a significant number of appropriate hypogonadal men will prefer an oral therapy that will help them restore their testosterone levels.”
Jatenzo’s proprietary formulation is built around testosterone undecanoate, a testosterone prodrug that converts to testosterone in the body. The drug is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, like primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). Jatenzo is not approved for use in men with hypogonadal conditions — such as age-related hypogonadism — not associated with structural or genetic etiologies. The safety and efficacy of Jatenzo has not been established in males less than 18 years old.
“AXYS ... is thrilled to see an oral testosterone medication available to our community,” noted Carol Meerschaert, executive director of the Association for X and Y Chromosome Variations (AXYS). “This new oral formulation is an important addition to available treatment options, and helps to address certain administration challenges.”
In the pivotal inTUne (investigational testosterone undecanoate) clinical trial, 87 percent of hypogonadal men (145 of 166) treated with Jatenzo achieved a mean total testosterone concentration in the eugonadal range at the end of treatment. The efficacy and safety of Jatenzo was evaluated in 166 adult hypogonadal males in a 4-month, open-label study. The primary endpoint was the percentage of patients with mean plasma total testosterone concentration (Cavg) over 24 hours within the normal eugonadal range on the final pharmacokinetic (PK) visit of the study. Some of the risks of taking Jatenzo include blood pressure increases that can increase the risk of major adverse cardiovascular events, including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death.
“The launch of Jatenzo means that healthcare providers, and their patients with indicated forms of hypogonadism, finally have an oral option, where liver toxicity was not observed in trials. Jatenzo offers patients a convenient softgel formulation, and eliminates the worry of gel transference, skin irritation from patches, or pain from injections that other testosterone treatments carry,” added Dr. Ronald S. Swerdloff, the lead investigator in the pivotal inTUne clinical trial, and Distinguished Professor of Medicine at the David Geffen School of Medicine at UCLA; chief of the Division of Endocrinology at Harbor-UCLA Medical Center; and senior investigator at The Lundquist Institute.