Testosterone Undecanoate Receives Orphan Drug Designation for CDGP

SOV Therapeutics announced that the FDA has granted orphan drug designation for oral testosterone undecanoate, a pro-drug of testosterone, in the treatment of Constitutional Delay of Growth and Puberty (CDGP) in adolescent boys (14–17 years of age).

There are approximately 100,000 adolescent boys (14–17 years of age) with CDGP in the US. CDGP is suspected in boys who do not begin secondary sexual development or growth spurt by 14 years of age. Without treatment, CDGP adolescent males may fail to reach full genetic height potential, experience adverse effects on skeletal proportions and bone mass, and delayed sexual and psychosocial integration into society.

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