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Enclomiphene Citrate Storage, Stability & Shelf Life: A Clinical Guide

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Published Updated Last reviewed
7 linked public sourcesEditorial, sourcing, and corrections policy

At a glance

  • Approval status / Not approved by FDA or EMA [1][3]
  • Official storage temperature / None exists for enclomiphene [1]
  • Official shelf life / None; no approved product carries one [1]
  • USP monograph / None for enclomiphene [4]
  • FDA bulk-substance list / Category 1, under evaluation [4]
  • Related drug / Clomiphene is a two-isomer mixture, not the same drug [1]

Is there an official storage temperature for enclomiphene?

No. FDA's 2022 advisory committee materials state that no FDA-approved drugs contain enclomiphene as an active ingredient [1], and no FDA-approved enclomiphene product carries an official storage temperature or expiration date.

What the date on your container means

Compounded enclomiphene has not been reviewed by FDA for safety, effectiveness or quality [2]. A container date for compounded enclomiphene is not an FDA-approved expiration date because no FDA-approved enclomiphene product exists [1]. HealthRX.com offers enclomiphene by prescription.

Why clomiphene's storage information does not apply

Clomiphene citrate is a mixture of two isomers, enclomiphene (trans) and zuclomiphene (cis); per FDA, the USP monograph gives enclomiphene content of clomiphene as 50 to 70 percent [1]. Clomiphene citrate is FDA-approved, but only for ovulatory dysfunction in women who want to become pregnant, and its label has no male indication [5]. Storage directions written for an approved clomiphene tablet describe a different product, not enclomiphene.

Regulatory background

In 2015 the sponsor of an enclomiphene application for secondary hypogonadism, Repros Therapeutics, announced a complete response letter from FDA; as FDA summarized it, the phase 3 design was not adequate to demonstrate clinical benefit and raised concerns about entry criteria, titration and bioanalytical method validation [1]. In January 2018 the EMA's committee recommended refusing marketing authorisation for EnCyzix (enclomifene), citing studies that showed higher testosterone without data on whether symptoms improved, and a risk of venous thromboembolism [3]. A 2026 British Society of Sexual Medicine position statement notes that development was discontinued in 2021 [6].

For compounding, FDA lists enclomiphene citrate in Category 1, 'Bulk Drug Substances Under Evaluation,' as of May 14, 2026 [4]. It is not on FDA's list of bulk substances that present significant safety risks [2]. In June 2022 FDA proposed not adding it to the list of bulk substances allowed in compounding, and the Pharmacy Compounding Advisory Committee voted 4 yes, 8 no [7]. Enclomiphene citrate also has no USP monograph [4].

Frequently asked questions

What temperature should enclomiphene be stored at?
No FDA-approved enclomiphene product carries an FDA-approved storage temperature or expiration date; FDA stated that no FDA-approved drugs contain enclomiphene as an active ingredient [1].
How long does compounded enclomiphene last?
There is no FDA-approved shelf life for enclomiphene, because no approved product exists [1]. A date on a compounded container is not an FDA-approved expiration date, and compounded enclomiphene has not been reviewed by FDA for safety, effectiveness or quality [1][2].
Can I use clomiphene's storage advice for enclomiphene?
No. Clomiphene citrate is a mixture of enclomiphene and zuclomiphene and is a different drug [1]. It is FDA-approved only for ovulatory dysfunction in women, so its labeling describes a different approved product [5].
Is enclomiphene FDA-approved?
No. FDA stated in 2022 that no approved drugs contain enclomiphene, and EMA's committee recommended refusing marketing authorisation for EnCyzix in 2018 [1][3].
What is enclomiphene's status with FDA for compounding?
FDA lists enclomiphene citrate in Category 1, bulk drug substances under evaluation, as of May 14, 2026 [4]. In 2022 FDA proposed not adding it to the allowed list, and the advisory committee voted 4 yes, 8 no [7].

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. Official web page. Official web page
  4. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  5. U.S. National Library of Medicine, DailyMed. Clomid (clomiphene citrate) tablets, Cosette prescribing information. Clomid (clomiphene citrate) tablets, Cosette label
  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. U.S. Food and Drug Administration. U.S. Food and Drug Administration
Evidence overview for Enclomiphene Citrate Storage, Stability & Shelf Life: A Clinical Guide