US FDA's New Hypogonadism Guidance Focuses On Non-Testosterone Products

Draft is intended to inform development of non-testosterone products such as aromatase inhibitors or estrogen receptor agonists.

female scientist working with microscope

The US FDA's draft guidance on drug development in male hypogonadotropic hypogonadism does not apply to testosterone products such as Clarus Therapeutics Inc.' Jatenzo that are being developed as replacement therapies and using a well-established pathway.

The new draft guidance, released Jan

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