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Enclomiphene Citrate Manufacturing, Supply & Shortage History

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At a glance

  • FDA approval / none; no approved product contains enclomiphene [1]
  • U.S. outcome / complete response letter to the sponsor in 2015 [1]
  • European outcome / negative opinion from EMA's committee, 25 January 2018 [3]
  • Development status / discontinued by the manufacturer in 2021 [4]
  • FDA bulk substance status / Category 1, under evaluation [2]
  • 2022 advisory vote / 4 yes, 8 no on adding it to the allowed list [5]
  • Studied oral doses / 6.25, 12.5 and 25 mg once daily [6]

Does an approved enclomiphene product exist?

No. FDA's June 2022 advisory committee materials state that no FDA-approved drugs contain enclomiphene as an active ingredient [1]. Sponsor Repros Therapeutics sought approval of Androxal for secondary hypogonadism in fertile men, and in 2015 announced a complete response letter from FDA which, as FDA summarised it, said the phase 3 study design was not adequate to demonstrate clinical benefit and raised concerns about study entry criteria, titration and bioanalytical method validation [1]. EMA's committee recommended refusing a marketing authorisation for EnCyzix (enclomifene) on 25 January 2018 [3]. A 2026 British Society of Sexual Medicine position statement says the manufacturer discontinued development in 2021 [4].

Where prescriptions come from

Enclomiphene has no FDA-approved product and no USP monograph, and it is not on FDA's final list of bulk substances that may be used in compounding [2]. FDA's list, updated 14 May 2026, places enclomiphene citrate in Category 1, 'Bulk Drug Substances Under Evaluation' [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]. On 8 June 2022 the Pharmacy Compounding Advisory Committee voted 4 yes, 8 no and 0 abstain on adding enclomiphene citrate to the allowed bulk-substances list; FDA still lists it as under evaluation [5][2].

HealthRX.com offers enclomiphene as a compounded prescription product.

What a compounded prescription involves

No FDA-approved dose exists [1]. Trials used 6.25, 12.5 and 25 mg once daily, and the phase 3 protocols used 12.5 mg daily, up-titrated to 25 mg at week 6 if morning testosterone stayed below 300 ng/dL [6][7]. Enclomiphene is one of the two isomers in clomiphene citrate; per FDA, the USP monograph gives enclomiphene content of clomiphene as 50 to 70 percent [1]. The Clomid label covers clomiphene tablets for ovulatory dysfunction in women and carries no male indication [8].

Frequently asked questions

Is enclomiphene FDA-approved?
No. FDA states that no FDA-approved drugs contain enclomiphene as an active ingredient, and EMA's committee recommended refusing a marketing authorisation for EnCyzix in January 2018 [1][3].
Who manufactures enclomiphene?
No FDA-approved enclomiphene product exists, so there is no approved manufacturer [1]. Repros Therapeutics was the sponsor of the Androxal application, and a 2026 position statement says the manufacturer discontinued development in 2021 [1][4].
Why is enclomiphene in Category 1?
FDA lists it as a bulk substance under evaluation, an enforcement-discretion policy rather than an approval; in June 2022 the committee voted 4 yes, 8 no on adding it to the allowed list [2][5].
Is enclomiphene the same as clomiphene?
No. Clomiphene citrate contains enclomiphene and zuclomiphene, and per FDA the USP monograph gives enclomiphene content of clomiphene as 50 to 70 percent; clomiphene tablets are approved for ovulatory dysfunction in women, not low testosterone in men [1][8].

References

  1. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  2. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  3. Official web page. Official web page
  4. 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
  5. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  6. Wiehle R, Cunningham GR, Pitteloud N, Wike J, Hsu K, Fontenot GK, et al. Testosterone Restoration by Enclomiphene Citrate in Men with Secondary Hypogonadism: Pharmacodynamics and Pharmacokinetics. BJU Int. 2013;112(8):1188-200. Testosterone Restoration by Enclomiphene Citrate in Men with Secondary Hypogonadism: Pharmacodynamics and Pharmacokinetics
  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 Enclomiphene Citrate Manufacturing, Supply & Shortage History