Clarus (NASDAQ: CRXT) Announces Initiation of Phase 4 Clinical Trial of JATENZO® (testosterone undecanoate) for the Treatment of Hypogonadal Men with Chronic Kidney Disease

JATENZO is the first and only FDA-approved oral softgel for testosterone (T) replacement therapy in adult males who have deficient T due to certain medical conditions

Clarus expects to announce results from the trial in the first half of 2023

NORTHBROOK, Ill., March 16, 2022 — Clarus Therapeutics Holdings, Inc. (Clarus) (NASDAQ: CRXT), a pharmaceutical company dedicated to providing solutions to unmet medical needs by advancing androgen and metabolic therapies for men and women, today announced the initiation of screening for the first patient in an investigator-initiated Phase 4 clinical trial designed to evaluate the efficacy and safety of JATENZO (testosterone undecanoate) oral softgel capsules for the treatment of adult hypogonadal men with chronic kidney disease (CKD). Clarus expects to announce results from the trial in the first half of 2023.

“We are excited screening has begun for the first patient in this trial of hypogonadal men with CKD,” said Dr. Robert Dudley, President and Chief Executive Officer of Clarus. “Patients with CKD suffer from a myriad of comorbidities, which often include profound reductions in circulating T. Epidemiological data indicate that an estimated two million men with CKD are clinically hypogonadal and thus may benefit from T replacement therapy. This will be the first of several life cycle management studies for JATENZO designed to maximize the potential for treatment of specific patient populations where T deficiency is a component of their compromised health.”

“We know in men suffering from CKD that T levels decrease as kidney function decreases. These men may also have a decrease in hemoglobin levels (anemia) that need to be treated with often expensive medications, such as epoetin,” said Sandeep Dhindsa, M.D., Division Director of Endocrinology at Saint Louis University School of Medicine in St. Louis, Missouri, and primary investigator in this trial. “Because JATENZO increases T levels and has a positive impact on hemoglobin levels, our hypothesis is that JATENZO, with its flexible oral dosing options, could become an important treatment option for hypogonadal adult men with CKD. These men also may prefer JATENZO over other T treatment modalities because it is administered orally as a softgel capsule.”

About Clarus’ Phase 4 Clinical Trial for JATENZO in Patients with CKD
This Phase 4 clinical trial (NCT05249634) is an investigator-initiated, single-center, single-arm study to investigate if adult men with Stage 3b or Stage 4 CKD and hypogonadism will show improvement when treated with JATENZO twice daily for 26 weeks. The primary endpoint is the achievement of T levels in the eugonadal (normal) range from baseline to after six months of treatment with JATENZO. Key secondary endpoints include measurement of hemoglobin, free T, lean mass, muscle strength, fat mass, sexual function assessment, quality of life, and key safety variables from baseline to after six months of treatment with JATENZO.

About Chronic Kidney Disease (CKD)
Chronic kidney disease is a condition where the kidney gradually loses function over time and can result in serious health problems and sometimes even death. An estimated 37 million adults in the United States have CKD, with diabetes and high blood pressure the leading causes of this condition. Over two million men with CKD also suffer from hypogonadism. Other health problems associated with CKD can include anemia, loss of muscle mass, and a decrease in quality of life.

About Male Hypogonadism
Male hypogonadism is a condition that results when the testes do not produce enough testosterone. Symptoms associated with male hypogonadism can include depression, decreased sex drive, decreased muscle mass, and decreased bone density, among others. An estimated 20 million men in the U.S. have hypogonadism, with approximately six million patients diagnosed. Treatments for male hypogonadism may include testosterone replacement therapy.

About Clarus Therapeutics Holdings, Inc.
Clarus Therapeutics Holdings, Inc. is a pharmaceutical company with expertise in developing androgen and metabolic therapies for men and women – including potential therapies for orphan indications. Clarus’ first commercial product is JATENZO® (testosterone undecanoate). For more information, visit and Follow us on Twitter (@Clarus_Thera) and LinkedIn (Clarus Therapeutics).

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