FDA approves Clarus’ Jatenzo as testosterone replacement therapy

Clarus Therapeutics announced that the U.S. Food and Drug Administration (FDA) has approved JATENZO (testosterone undecanoate capsules for oral use) (CIII) for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). Important Safety Information, including a Boxed Warning is provided below.

JATENZO is a first-in-class proprietary softgel oral formulation, and the first oral testosterone medicine approved in more than 60 years.1 FDA approval is based on Phase 3 inTUne clinical trial data, which showed 87 percent of hypogonadal men treated with JATENZO achieved a daily average testosterone level in the normal range, with an adverse events profile generally consistent with other T replacement therapies.

“The approval of oral JATENZO represents a new and significant treatment option for hypogonadal men,” said Dr. Robert E. Dudley, President and Chief Executive Officer of Clarus. “We believe that an oral testosterone replacement therapy may offer appropriate adult male patients and their physicians the opportunity to reconsider treatment options, and help hypogonadal men find relief from their symptoms.”

Patient adherence can be an issue with testosterone treatment. The oral delivery of JATENZO eliminates the risks of testosterone transference to women or children that can occur with gels, application site irritation common with the transdermal testosterone patch, and discomfort associated with deep muscle injections of testosterone formulations. JATENZO is an important addition to the class of drugs used to treat various forms of testosterone deficiency.

“JATENZO will fill an important void by providing physicians with an oral testosterone formulation FDA has found to be safe and effective to treat adult men with documented hypogonadism associated with structural or genetic etiologies,” said Dr. Ronald Swerdloff, Distinguished Professor of Medicine at the David Geffen School of Medicine at UCLA, Senior Scientist at the Los Angeles Biomedical Research Institute and Principal Investigator for the JATENZO clinical trials. “Availability of a safe and effective oral testosterone dosage form has long been a desire of many of my hypogonadal patients.”

JATENZO will be available in three dosages: 158 mg, 198 mg and 237 mg, for twice daily administration with food. Clarus expects JATENZO to be available in U.S. pharmacies before the end of the year.

“We represent thousands of men who struggle to maintain adequate levels of testosterone, many of whom do not start or stay on testosterone therapy because of issues with the current formulations,” said Carol Meerschaert, Executive Director of the Association for X and Y Variations (AXYS), an advocacy, education and support organization for individuals with X and Y chromosome variations and their families. “An oral testosterone medication, which AXYS has supported since early trials were first announced, could make a significant difference in their physical and mental well-being and we hope will help them to lead fuller, more productive lives.”

JATENZO is not for use in men with hypogonadal conditions, such as “age-related hypogonadism,” that are not associated with structural or genetic etiologies. Please see Important Safety Information below, including Boxed Warning for information about potential increased blood pressure associated with JATENZO.