Clarus Therapeutics

Clarus Therapeutics Holdings, Inc. was a pharmaceutical company focused on androgen and metabolic therapies for men and women. Founded in 2004 by Dr. Robert E. Dudley, the company's operations were based in Northbrook, Illinois. Dr. Dudley, who also served as President and CEO, had a significant background in the field, having previously led the discovery and launch of AndroGel, a leading testosterone replacement therapy. The company's primary objective was to develop and commercialize an oral testosterone replacement option, addressing the demand for a more convenient alternative to non-oral treatments like gels and patches.

The company's sole commercial product was JATENZO, an FDA-approved oral softgel capsule of testosterone undecanoate. This product was developed for testosterone replacement therapy in adult males with conditions associated with a deficiency or absence of endogenous testosterone. JATENZO's formulation as a softgel was designed to facilitate the absorption of testosterone through the intestinal lymphatic system, offering an alternative to topical gels that carry a risk of transference. The business model centered on the commercialization of JATENZO, which was its only source of revenue. The company served healthcare providers and patients in the men's health market, specifically those dealing with hypogonadism.

A significant milestone for Clarus was the FDA approval of JATENZO in March 2019, making it the first oral testosterone medicine approved in over 60 years. The company went public in September 2021 through a merger with a special purpose acquisition company (SPAC), Blue Water Acquisition Corp. Despite initial growth in prescriptions for JATENZO, the company faced significant financial challenges. In August 2022, Clarus announced a 40% reduction in its workforce and other cost-cutting measures due to these difficulties. Subsequently, in September 2022, Clarus Therapeutics filed for Chapter 11 bankruptcy protection. The company proceeded with a court-authorized sale of its main asset, JATENZO, to Tolmar, Inc. in October 2022. The company's plan of liquidation became effective on February 28, 2023, leading to the cessation of its business operations.

Keywords: Clarus Therapeutics, JATENZO, testosterone replacement therapy, oral testosterone undecanoate, hypogonadism, men's health, androgen therapy, Robert E. Dudley, pharmaceutical, metabolic therapies, Blue Water Acquisition, Chapter 11 bankruptcy, Tolmar Inc, testosterone deficiency, oral drug formulation, specialty pharmaceutical