Does State Medicaid Cover Enclomiphene Citrate?

Is there an approved enclomiphene product a state program could cover?

No. Enclomiphene is not FDA-approved, and FDA's June 8, 2022 advisory-committee presentation states that no FDA-approved drugs contain enclomiphene as an active ingredient [1]. The sponsor, Repros Therapeutics, filed a new drug application for enclomiphene (Androxal) for secondary hypogonadism in fertile men. In 2015 the company announced a complete response letter, which as FDA summarises it said the phase 3 study design was not adequate to demonstrate clinical benefit and raised concerns about entry criteria, titration and bioanalytical method validation [1]. No approval has followed.

What about compounded enclomiphene?

Enclomiphene citrate is in Category 1 on FDA's bulk drug substances list, 'Bulk Drug Substances Under Evaluation' (updated 14 May 2026) [2]. 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 enforcement discretion, not an approval and not a finding that the product is safe or effective [2]. At the June 8, 2022 meeting of FDA's Pharmacy Compounding Advisory Committee, FDA proposed that enclomiphene citrate not be added to the allowed bulk substances list, and the vote was 4 yes, 8 no [3]. Compounded enclomiphene products are not FDA-approved and have not been reviewed by FDA for safety, effectiveness or quality [6].

Does clomiphene citrate's approval change the answer?

No. Clomiphene citrate (Clomid and generics) is FDA-approved only for ovulatory dysfunction in women who want to become pregnant [4]. Its label has no male indication and states that there are no adequate or well-controlled studies demonstrating effectiveness of clomiphene citrate in the treatment of male infertility; testicular tumors and gynecomastia have been reported in men using clomiphene, with cause and effect not known [4]. Use in men with low testosterone is off-label [4]. Clomiphene is a mixture of enclomiphene and zuclomiphene, and per FDA the USP monograph gives enclomiphene content of clomiphene as 50 to 70 percent [1].

Where state Medicaid rules fit

Enclomiphene has no FDA-approved product for a state program to list [1]. Coverage of a compounded product would be a separate, state-by-state question. FDA proposed in 2022 against adding the bulk substance to the compounding list [3], and compounded enclomiphene has not been reviewed by FDA for safety, effectiveness or quality [6].