Clarus Therapeutics Announces FDA Approval of Jatenzo, First Oral Testosterone Replacement Therapy for Hypogonadism in Younger Men

VCBeat (WeChat ID: vcbeat) has learned that biopharmaceutical company Clarus Therapeutics recently announced that its oral capsule, Jatenzo, has received FDA approval for the treatment of male hypogonadism.

Male hypogonadism, also known as testosterone deficiency, is a condition characterized by diminished sexual function resulting from insufficient androgen levels and the inability to produce adequate testosterone. According to statistics from the American Urological Association, 40% of men under the age of 60 have low testosterone levels. Data indicate that in 2018 alone, 7 million prescriptions for testosterone replacement therapy to treat this condition were issued across major hospitals in the United States, with the market share reaching $1.6 billion.

Clarus Therapeutics is a biopharmaceutical company headquartered in Illinois, USA, specializing in drug development for male health conditions. Since its establishment in 2003, the company has completed four rounds of financing, raising a total of $42 million. In 2014, it secured $31.5 million in funding led by C-Bridge Capital.

Clarus Therapeutics’ flagship product is Jatenzo, an oral formulation of testosterone undecanoate. This soft gel capsule facilitates absorption via the intestinal lymphatic system and is the first oral testosterone medication approved by the FDA. Compared with currently approved testosterone replacement therapies on the market, Jatenzo offers two key advantages: First, it enhances testosterone bioavailability and minimizes the impact of food on drug absorption. Second, as an easy-to-swallow soft gel capsule, it provides greater convenience for patients.

It is understood that Jatenzo is available in three dosages: 158 mg, 198 mg, and 237 mg, to be taken twice daily with food. Clinical trials have shown that 87% of men treated with oral Jatenzo achieved normal ranges of endogenous testosterone circulation levels. The company expects Jatenzo to be available at major pharmacies across the United States by the end of this year.

Hylton V. Joffe, Director of the Division of Reproductive and Urologic Products at the FDA’s Center for Drug Evaluation and Research, stated, “It is particularly important to note that Jatenzo is not suitable for elderly male patients with this condition, as the drug can cause elevated blood pressure, thereby increasing the risk of heart attack, stroke, and cardiovascular death.”

Dr. Robert E. Dudley, President and CEO of Clarus Therapeutics, also stated, “In the Jatenzo clinical trials, more than 2% of patients experienced adverse effects including headache, increased hematocrit (red blood cell count), decreased high-density lipoprotein (HDL) cholesterol, hypertension, and nausea. Therefore, we recommend that the oral formulation Jatenzo be used under medical supervision, and that this medication is more suitable for younger male patients.”

(Compiled by Feng Yutong)