The FDA has approved Azmiro (Azurity), the first injectable formulation of testosterone cypionate to become available in single-dose vials and prefilled syringes for treatment of males with conditions associated with a deficiency or absence of endogenous testosterone. Injectable testosterone cypionate has been available in multidose vials (Depo-Testosterone, and generics) for many years. Testosterone enanthate (Xyosted) is available in prefilled autoinjectors for use in adult men. No testosterone products are approved for treatment of low testosterone levels due solely to aging. All testosterone products are classified as schedule III controlled substances.

The FDA has approved two new oral formulations of testosterone undecanoate — Kyzatrex (Marius) and Tlando (Antares) — for treatment of males with a deficiency of endogenous testosterone due to conditions such as Klinefelter syndrome, orchiectomy, toxic damage from chemotherapy or alcohol, or pituitary-hypothalamic injury caused by tumors, trauma, or radiation. Jatenzo, another oral testosterone undecanoate formulation, was approved for the same indication in 2019. No testosterone products are approved for treatment of low testosterone levels due solely to aging.

The FDA has approved an auto-injector formulation of testosterone enanthate (Xyosted – Antares Pharma) for once-weekly subcutaneous self-administration in adult males with conditions associated with a deficiency or absence of endogenous testosterone. It is the first subcutaneous formulation of testosterone to be approved by the FDA. Xyosted is contraindicated for treatment of low testosterone levels associated with aging.

Three coordinated double-blind, placebo-controlled clinical trials have evaluated the efficacy of one year of testosterone replacement therapy in improving sexual function, physical function, and vitality in a total of 790 men ≥65 years old with moderately low serum testosterone concentrations and symptoms suggesting hypoandrogenism. Sexual function improved modestly, and there appeared to be marginal benefits in some areas of physical function and vitality as well. The trials were not designed to evaluate the safety of testosterone replacement therapy.

The FDA has approved testosterone undecanoate (Aveed – Endo), an injectable depot formulation, for use in men with hypogonadism who require testosterone replacement therapy.