Clarus Therapeutics has announced that the US Food and Drug Administration (FDA) has approved its oral testosterone undecanoate (TU) Jatenzo for testosterone replacement therapy.

The drug is indicated for a deficiency or absence of endogenous testosterone, such as primary hypogonadism and hypogonadotropic hypogonadism. However, it is not approved for age-related hypogonadal conditions, which are not caused by structural or genetic etiologies.

Clarus claims it is the first oral testosterone medicine approved in more than 60 years. Oral formulations are seen as superior to current therapies as topic gels bring a risk of transference to women or children and transdermal patches commonly cause application site irritation.

The company is a male health specialist and Jatenzo is its main product. The first-in-class drug contains undecanoate to facilitate the absorption of testosterone through the intestinal lymphatic system. The drug has been formulated so it is less impacted by food after being absorbed.

The FDA’s decision is based upon data from the InTUne clinical trial where Jatenzo was compared to a topical testosterone formulation called Axiron. The study met its primary endpoint with 87% of the Jatenzo group achieved a daily average testosterone level in the normal range. These results were consistent with the other two previous Phase III trials of the drug.

Jatenzo’s safety profile was similar to other testosterone replacement therapies on the market.

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Clarus chief executive officer and president Dr Robert Dudley said: “The approval of oral Jatenzo represents a new and significant treatment option for hypogonadal men.

“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.”

Principal investigator of Jatenzo trials, professor of medicine at UCLA David Geffen School of Medicine and Los Angeles Biomedical Research Institute senior scientist Dr Ronald Swerdloff said: “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.

“Availability of a safe and effective oral testosterone dosage form has long been a desire of many of my hypogonadal patients.”