Does Blue Cross Blue Shield (Federated) Cover Enclomiphene Citrate?

Is there an FDA-approved enclomiphene product?

No. FDA's 8 June 2022 advisory committee presentation says no FDA-approved drugs contain enclomiphene as the active ingredient [1]. The sponsor, Repros Therapeutics, filed an application for Androxal in secondary hypogonadism in fertile men. FDA issued a complete response letter on that application in 2015, and enclomiphene has not since been approved [1].

Europe took the same route. The CHMP adopted a negative opinion on EnCyzix (enclomifene) on 25 January 2018. Its review covered 4 main studies in 588 patients; testosterone rose, but the studies did not assess whether symptoms improved, and venous thromboembolism was a risk [3]. The British Society of Sexual Medicine's 2026 position statement says the manufacturer discontinued development in 2021 and that long-term efficacy and safety data are lacking [6].

What is FDA's position on compounding?

FDA's list updated 14 May 2026 places enclomiphene citrate in Category 1, 'Bulk Drug Substances Under Evaluation'. FDA says it does not intend to take action against a compounder using a Category 1 substance if the conditions in its guidance are met; that is an enforcement-discretion policy, not an approval and not a finding of safety or effectiveness [2].

At the 8 June 2022 Pharmacy Compounding Advisory Committee, FDA proposed not adding enclomiphene citrate to the allowed bulk substances list. The committee voted 4 yes, 8 no [4].

Does BCBS Federated cover it?

No FDA-approved enclomiphene product exists [1], so there is no approved product for a plan formulary to list.

Clomiphene citrate is not the same drug. It is a mixture of enclomiphene and zuclomiphene, and it is FDA-approved for ovulatory dysfunction in women; its label has no male indication [1][5].