H.I.G. Capital News

Clarus Therapeutics Receives U.S. FDA Approval of JATENZO® (Testosterone Undecanoate Capsules for Oral Use) (CIII) for Testosterone Replacement Therapy in Certain Adult Men

  • JATENZO is a first-in-class proprietary softgel oral formulation of testosterone undecanoate for testosterone replacement therapy in certain adult men, and the first oral testosterone medicine approved in more than 60 years.
  • 87 percent of hypogonadal men treated with JATENZO in the pivotal Phase 3 study had a mean total testosterone concentration in the normal range at the end of treatment

NORTHBROOK, IL – April 3, 2019 - Clarus Therapeutics, Inc., today 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.

About the inTUne Trial
The inTUne trial was a multicenter, randomized, open-label, study designed to evaluate the efficacy and safety of JATENZO in adult hypogonadal male subjects. An active comparator group received Axiron®, a topical testosterone formulation. A total of 222 patients were randomized in a 3:1 ratio to JATENZO (n=166) or Axiron (n=56). The primary efficacy endpoint was the percentage of patients in the JATENZO group with an average testosterone level in the normal male range.

Both the percentage of patients (87.3%) and the lower bound of the 95% confidence interval (81.3%) met the FDA targets of ≥ 75% and ≥ 65%, respectively; therefore, the efficacy criteria were satisfied and the study met its primary endpoint. The safety profile of JATENZO was consistent with data generated in two earlier Phase 3 trials and the general safety profiles for T replacement products as a therapeutic class. JATENZO was associated with an increase in average systolic blood pressure consistent with a currently marketed form of injectable testosterone. Importantly, the inTUne trial confirmed the efficacy of JATENZO that was demonstrated in the earlier Phase 3 trials but further refined the dose adjustment scheme.

About Hypogonadism
Hypogonadism, also known as testosterone deficiency, is a condition in men in which the body does not produce enough testosterone. Only those men who are symptomatic and have consistently low results on a reliable testosterone assay should be offered testosterone replacement therapy, according to current treatment guidelines from both the Endocrine Society and the American Urological Association.2,3 Treatment is meant to induce and maintain secondary sex characteristics and improve bone mineral density, sexual function, sense of well-being, muscle mass and strength. In 2018, approximately 7 million testosterone replacement therapy prescriptions were written by healthcare providers, with estimated total sales of $1.6 billion.4

About Clarus Therapeutics
Clarus is a men's specialty pharmaceutical company developing and preparing for the commercial launch of JATENZO, a first-in-class proprietary softgel oral formulation of testosterone undecanoate for testosterone replacement therapy in certain adult males protected by patents issued in the United States and in other major pharmaceutical markets around the world. JATENZO is the first oral testosterone prodrug FDA-approved to treat men diagnosed with hypogonadism associated with structural and genetic etiologies. Clarus owns the worldwide, royalty-free commercialization rights for JATENZO. For more information, please visit: www.clarustherapeutics.com

For full prescribing information please visit WWW.JATENZO.COM

  1. American Professional Pharmacist (1947), Vol 13, pp. 877 [Oreton-M (Schering Corp. trade name for methyltestosterone)]. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=080767 Accessed March 2019
  2. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline, 2018. https://www.endocrine.org/guidelines-and-clinical-practice/clinical-practice-guidelines/testosterone-therapy Accessed March 2019
  3. Evaluation and Management of Testosterone Deficiency: AUA Guideline, 2018. https://www.auanet.org/guidelines/testosterone-deficiency-guideline Accessed March 2019
  4. IMS Health