Is Enclomiphene FDA Approved? | Elite Bio Supply

Is Enclomiphene FDA Approved?

No. Enclomiphene is not FDA approved, nor is it approved by Health Canada or any other major regulatory agency. The story behind its rejection is important context for researchers.

Development history: Repros Therapeutics developed enclomiphene (brand name Androxal) specifically for male secondary hypogonadism. It is the purified trans-isomer of clomiphene, isolated from the two-isomer mixture found in Clomid. The rationale was to provide the testosterone-raising benefits of clomiphene without the estrogenic side effects caused by zuclomiphene (the cis-isomer).

Clinical trials: Enclomiphene went through multiple Phase II and Phase III clinical trials involving hundreds of men. The trials demonstrated that enclomiphene reliably raised testosterone to the normal range (300-900 ng/dL) while preserving sperm production. The safety profile was favourable compared to Clomid, with fewer visual disturbances and lower estradiol elevation.

FDA rejection (2015): The FDA issued a Complete Response Letter (CRL) rejecting the Androxal NDA. The rejection was based on Chemistry, Manufacturing, and Controls (CMC) deficiencies, meaning the FDA had concerns about the manufacturing process and quality control, not about the drug’s safety or efficacy. Repros Therapeutics was later acquired by Allergan, and no company has since pursued the application.

Current status: Enclomiphene remains an unapproved investigational compound. It is available from research compound suppliers for research purposes only.