Does Cigna Cover Enclomiphene Citrate?

Is Enclomiphene an Approved Drug?

No. FDA's advisory-committee presentation from June 8, 2022 states that no FDA-approved drugs contain enclomiphene as an active ingredient [1]. The sponsor filed a new drug application for Androxal (enclomiphene) for secondary hypogonadism in fertile men; in 2015 it announced a complete response letter, which as FDA summarized it said the phase 3 study design was not adequate to demonstrate clinical benefit [1]. No approval followed, and a 2026 British Society of Sexual Medicine position statement still describes enclomiphene as unapproved by FDA and EMA [5].

What Is FDA's Position on Compounded Enclomiphene?

FDA's list updated May 14, 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 its guidance conditions are met, which is enforcement discretion, not an approval or a finding of safety [3]. At the June 8, 2022 advisory committee, FDA proposed not adding enclomiphene citrate to the allowed bulk list; the vote was 4 yes and 8 no, with members who voted no citing a lack of clinical efficacy evidence [6].

Does Clomiphene's Approval Help?

Clomiphene citrate (Clomid and generics, oral tablet) is FDA-approved only for ovulatory dysfunction in women who want to become pregnant, and male use is off-label [4]. The label states there are no adequate or well-controlled studies demonstrating effectiveness in male infertility [4]. Clomiphene is a mixture of enclomiphene (trans) and zuclomiphene (cis); the USP monograph gives enclomiphene content as 50 to 70 percent [1].