Androxal FDA Approval Status
FDA Approved: No
Brand name: Androxal
Generic name: enclomiphene
Company: Repros Therapeutics Inc.
Treatment for: Hypogonadism, Male
Androxal (enclomiphene) is a non-steroidal estrogen receptor antagonist in development for secondary hypogonadism in overweight men wishing to restore normal testicular function.In December 2015, Repros Therapeutics Inc. announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application for enclomiphene. The FDA stated that, based on recent scientific developments, the design of enclomiphene Phase 3 studies was no longer adequate to demonstrate clinical benefit and recommended that Repros conduct an additional Phase 3 study or studies to support approval in the target population. The FDA also noted concerns regarding study entry criteria, titration and bioanalytical method validation in the Phase 3 program.
Development Timeline for Androxal
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