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Does Anthem (Elevance Health) Cover Enclomiphene Citrate?

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At a glance

  • FDA approval / None; no approved drug contains enclomiphene [1]
  • Compounded enclomiphene / Compounded products are not FDA-approved and have not been reviewed by FDA for safety, effectiveness or quality [2]
  • FDA bulk-substance status / Category 1, under evaluation [3]
  • 2022 FDA advisory committee vote / 4 yes, 8 no on adding it to the compounding list [4]
  • EMA committee / Recommended refusal, 25 January 2018 [5]
  • Long-term safety data / Lacking, per a 2026 specialty-society statement [6]

Does Anthem cover enclomiphene citrate?

There is no FDA-approved enclomiphene product to place on a formulary [1].

Regulatory history

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; FDA summarized it as saying the phase 3 designs were not adequate to demonstrate clinical benefit [1]. No approval has followed [1].

EMA's CHMP adopted a negative opinion on 25 January 2018 recommending refusal of marketing authorisation for EnCyzix (enclomifene) for hypogonadotropic hypogonadism in overweight men. Studies showed higher testosterone but did not examine whether symptoms improved, and there was a risk of venous thromboembolism [5].

FDA lists enclomiphene citrate in Category 1, bulk drug substances under evaluation [3]. FDA proposed in 2022 that it not be added to the allowed list, and its advisory committee voted 4 yes, 8 no [4]. FDA says it does not intend to act against a compounder using a Category 1 substance when its guidance conditions are met; that is enforcement discretion, not approval or a finding of safety and effectiveness [3]. A 2026 British Society of Sexual Medicine position statement notes that the manufacturer discontinued development in 2021 and that long-term efficacy and safety data are lacking [6].

Safety concerns on the record

FDA listed cardiac and thromboembolic events, including pulmonary embolism and deep vein thrombosis in a safety study, raised estradiol, raised PSA, raised hematocrit, and the absence of long-term safety data [1]. EMA noted a slightly higher rate of cardiac and thromboembolic events than with testosterone [1]. In phase 3 and EMA data, the most frequent side effects were headache, hot flushes, nausea and muscle spasm; reasons for stopping included blurred vision, muscle spasm, headache and aggression [7].

The FDA-approved clomiphene product is a different drug, a mixture of enclomiphene and zuclomiphene, indicated only for ovulatory dysfunction in women, with no male indication on its label [1][8].

Frequently asked questions

Does Anthem cover enclomiphene citrate?
No FDA-approved drug contains enclomiphene as an active ingredient, so there is no approved enclomiphene product for a formulary to list [1]. Compounded enclomiphene is not FDA-approved and has not been reviewed by FDA for safety, effectiveness or quality [2].
Is enclomiphene citrate FDA-approved?
No. In 2015 the sponsor announced a complete response letter for Androxal, and FDA said the phase 3 designs were not adequate to demonstrate clinical benefit [1]. EMA recommended refusing marketing authorisation for EnCyzix in January 2018, citing that symptom improvement was not studied and a venous thromboembolism risk [5].
Can a compounding pharmacy make enclomiphene?
FDA lists enclomiphene citrate in Category 1, bulk drug substances under evaluation, and says it does not intend to act against a compounder using a Category 1 substance when guidance conditions are met; that is enforcement discretion, not approval [3]. In 2022 FDA proposed not adding it to the allowed list and the advisory committee voted 4 yes, 8 no [4].
Is enclomiphene the same as Clomid?
No. Clomiphene citrate is a mixture of enclomiphene and zuclomiphene. The FDA-approved clomiphene product is indicated only for ovulatory dysfunction in women and its label has no male indication [1][8].

References

  1. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  2. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA
  3. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  4. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  5. Official web page. Official web page
  6. Foster J, Choo L, Patel A, Kirby M, Hackett G. British Society of Sexual Medicine: Position Statement for the Potential Use of Enclomiphene in the Treatment of Male Hypogonadism. World J Mens Health. 2026;44(3):480-483. British Society of Sexual Medicine: Position Statement for the Potential Use of Enclomiphene in the Treatment of Male Hypogonadism
  7. Official web page. Official web page
  8. U.S. National Library of Medicine, DailyMed. Clomid (clomiphene citrate) tablets, Cosette prescribing information. Clomid (clomiphene citrate) tablets, Cosette label
Evidence overview for Does Anthem (Elevance Health) Cover Enclomiphene Citrate?