Enclomiphene Citrate

Dosing from the Literature

Published for low testosterone: 12.5 or 25 mg a day by mouth, the doses in two Phase 3 trials. Not published: an FDA-approved dose; the FDA declined it in 2015.

Doses below are the published trial doses. Always work with a licensed clinician.

What It Is

Enclomiphene citrate is the trans isomer of clomiphene citrate, a selective estrogen receptor modulator (SERM) (Rodriguez et al., 2016). Clomiphene citrate, FDA-approved as Clomid in 1967 (Drugs@FDA through openFDA, read October 18, 2026) and used since the 1960s to induce ovulation in women (Rodriguez et al., 2016), is a mixture of two isomers: about 62% enclomiphene and 38% zuclomiphene (Wiehle et al., 2013). A 2016 review describes enclomiphene as an estrogen receptor antagonist with a half-life of about 10 hours, and zuclomiphene as an estrogen receptor agonist with a half-life of about 30 days that caused estrogenic side effects often reported with clomiphene (Rodriguez et al., 2016).

Repros Therapeutics developed enclomiphene and applied to market it for secondary hypogonadism in overweight men wishing to restore normal testicular function (Repros Therapeutics, December 1, 2015). The idea: blocking estrogen’s feedback at the hypothalamus and pituitary raises LH and FSH, so the testes make more of their own testosterone and keep making sperm (Rodriguez et al., 2016; Mulhall et al., 2018; Kim et al., 2016). Testosterone given as a treatment suppresses that axis and can leave men severely oligospermic or azoospermic (Mulhall et al., 2018).

Repros ran Phase 2 and Phase 3 trials of 12.5 mg and 25 mg a day by mouth against placebo and testosterone gel (Rodriguez et al., 2016; Kim et al., 2016; Wiehle et al., 2013; NCT01993212, NCT01993225). In the Phase 3 trials, enclomiphene raised total testosterone into the normal range and kept sperm concentration in the normal range, while testosterone gel lowered LH, FSH and sperm counts (Kim et al., 2016). Repros announced on December 1, 2015 that the FDA had declined to approve it: the letter said the Phase 3 design was no longer adequate to show clinical benefit, and noted concerns about the trials’ entry criteria, titration and bioanalytical method validation (Repros Therapeutics, December 1, 2015). In the EU, the EMA’s committee recommended refusal on January 25, 2018 (European Medicines Agency, 2018), and the European Commission refused the marketing authorisation on April 6, 2018 (European Commission, April 6, 2018).

Enclomiphene is compounded by 503A pharmacies in the United States on a clinician’s prescription: it is on FDA’s 503A Category 1 list (FDA 503A categories list, May 14, 2026), where compounding is permitted under FDA’s interim policy; it has no 503B pathway (it is not on the 503B bulks list or in any 503B category: FDA 503B categories list, March 21, 2025; FDA 503B bulks list, August 21, 2023). In short: Phase 3 trials showed it raises the body’s own testosterone (Kim et al., 2016); it is not FDA-approved; and its use today is a compounded prescription, not an approved product.

Mechanism of Action

Enclomiphene occupies estrogen receptors in the hypothalamus, which blocks estradiol's negative feedback; LH and FSH rise and the testes make more of their own testosterone (Rodriguez et al., 2016).

• Estrogen receptor antagonism at hypothalamus/pituitary — Estradiol normally holds back LH release; SERMs block that negative feedback at the hypothalamus and pituitary (Mulhall et al., 2018). Enclomiphene is thought to compete with estrogen for its receptor binding sites there (Rodriguez et al., 2016).
• LH and FSH elevation — In the 6-week study, LH and FSH rose on enclomiphene and fell on testosterone gel; 25 mg raised them more than 6.25 or 12.5 mg (Wiehle et al., 2013).
• Leydig cell stimulation → endogenous testosterone — LH drives the testes' Leydig cells to make testosterone, and in men with low testosterone a low or low-normal LH points to a defect in the hypothalamus or pituitary rather than the testes (Mulhall et al., 2018). In the 2013 study, enclomiphene reversed both hallmarks of secondary hypogonadism, low testosterone and low or inappropriately normal LH (Wiehle et al., 2013).
• FSH preserves spermatogenesis — Sperm production depends on pituitary LH and FSH supporting testosterone inside the testes; exogenous testosterone suppresses that axis and can leave men severely oligospermic or azoospermic (Mulhall et al., 2018). In the Phase 3 trials, LH and FSH rose on enclomiphene and fell on testosterone gel, and sperm concentration stayed in the normal range on enclomiphene and fell sharply on the gel (Kim et al., 2016).
• Antagonist vs agonist (the isomer distinction) — Enclomiphene is described as an estrogen receptor antagonist and zuclomiphene as an agonist that caused the estrogenic side effects reported with clomiphene (Rodriguez et al., 2016); the clomiphene label says both isomers have mixed estrogenic and antiestrogenic effects, with some data suggesting zuclomiphene is the more estrogenic (Clomid label). This led to the hypothesis that enclomiphene alone would avoid those side effects: a 2016 review said it had yet to be proven in hypogonadal men (Rodriguez et al., 2016), while a 2019 review says initial studies showed enclomiphene keeps clomiphene's androgenic benefit without zuclomiphene's unwanted effects (Earl & Kim, 2019).
• Estradiol elevation (downstream) — Enclomiphene raised serum estradiol in its trials (Wiehle et al., 2013; Rodriguez et al., 2016). In men, about 80% of circulating estradiol is made from testosterone by aromatization (Rodriguez et al., 2016).
• Half-life and lasting effect — About 10 hours (Rodriguez et al., 2016), or about 7 hours by the 2013 study's account (Wiehle et al., 2013); the trials gave it once a day (Kim et al., 2016). Serum levels had not returned to baseline 24 hours after a dose, and LH and testosterone stayed up for at least a week after the last dose, an effect the authors did not attribute to drug accumulation and suggested could lead to an intermittent dosing regimen (Wiehle et al., 2013).
• What it does not do — Clomiphene, the two-isomer mixture, has no apparent androgenic or antiandrogenic effect (Clomid label). For primary hypogonadism, where the testes themselves fail, a 2016 review names testosterone as the only option (Rodriguez et al., 2016), and the AUA guideline calls a higher SERM dose unlikely to raise testosterone when LH is high (Mulhall et al., 2018).

What the Research Shows

Repros Therapeutics ran the enclomiphene trials below (Wiehle et al., 2013; NCT01993212, NCT01993225). They measured hormones and sperm counts; none measured symptoms or quality of life with validated questionnaires (Rodriguez et al., 2016).

• Hill et al. 2009 — review of the early trials — A drug review, not a trial: it reports that in the trials to date enclomiphene restored testosterone in men with secondary hypogonadism, with short-term safety equivalent to testosterone gel and placebo and an unexpected favorable effect on fasting glucose (Hill et al., 2009). An early Phase 2 study gave 52 men with secondary hypogonadism enclomiphene for 2 weeks; testosterone, LH and FSH rose (Wiehle et al., 2013).
• Wiehle et al. 2013 — PK/PD (PMC4155868) — 48 men randomized to 6.25, 12.5, 25 mg enclomiphene daily vs transdermal testosterone for 6 weeks. All three doses raised testosterone. Critically, the effects on LH and testosterone persisted for at least 7 days after enclomiphene discontinuation, which the authors could not explain by drug accumulation, given a serum half-life of about 7 hours.
• Kim et al. 2016 BJU Int — Phase 3 RCTs (PMID 26496621) — Two parallel randomized double-blind double-dummy placebo-controlled multicenter Phase 3 trials. Compared two enclomiphene doses (12.5 mg and 25 mg) vs AndroGel 1.62% vs placebo in overweight men aged 18-60 with secondary hypogonadism. Findings: enclomiphene consistently increased serum total testosterone, LH, and FSH; restored normal serum testosterone; maintained sperm concentrations in the normal range; AndroGel raised testosterone but reduced sperm counts. This is the pivotal efficacy dataset.
• IGF-1 lowering signal (Wiehle 2013 AACR abstract) — In secondary hypogonadism trial cohorts, oral enclomiphene lowered serum IGF-1 (more than topical testosterone or placebo) while raising testosterone. Its title draws implications for cancer prevention.
• Mixed-clomiphene literature — Clomiphene, the two-isomer mixture, has been used off-label for many years to raise LH, FSH and testosterone in men with secondary hypogonadism and to raise sperm counts (Rodriguez et al., 2016); zuclomiphene is thought to cause some of its side effects (Wiehle et al., 2013).
• Helo 2015 J Sex Med — clomiphene vs anastrozole — Randomized prospective double-blind comparison of clomiphene vs anastrozole in raising testosterone in hypogonadal infertile men. Both effective; different mechanisms (SERM vs aromatase inhibitor).
• FDA complete response letter (announced December 1, 2015) — The FDA declined to approve it: the Phase 3 design was no longer adequate to show clinical benefit, and it noted concerns about the trials’ entry criteria, titration and bioanalytical method validation (Repros Therapeutics, December 1, 2015).
• EU refusal (April 2018) — The EMA’s committee recommended refusal on January 25, 2018, because the trials did not look at symptoms, because of a risk of blood clots, and because its long-term non-clinical safety data were not sufficient (European Medicines Agency, 2018); the European Commission refused the marketing authorisation on April 6, 2018 (European Commission, April 6, 2018).

Human Data

Enclomiphene's human data come from Repros's Phase 2 and Phase 3 trials (Rodriguez et al., 2016).

• Hill et al. 2009 — A drug review of the early Repros trials, not a study itself; it reports short-term safety equivalent to testosterone gel and placebo (Hill et al., 2009).
• Wiehle et al. 2013 PK/PD (PMC4155868) — 48 men, 6 weeks, three doses of enclomiphene vs transdermal testosterone. Effects on LH and testosterone persisted for at least 7 days after stopping.
• Kim et al. 2016 BJU Int Phase 3 (PMID 26496621) — Two parallel randomized double-blind multicenter Phase 3 trials. Pivotal efficacy dataset.
• NCT01993212, NCT01993225 — Repros Phase 3 ZA-304 / ZA-305 — The two identical Phase 3 trials behind Kim 2016, registered on ClinicalTrials.gov (completed 2014).
• Older mixed-clomiphene off-label literature — Clomiphene has been used off-label for many years to raise testosterone and sperm counts in men (Rodriguez et al., 2016). The AUA guideline lists 25–50 mg every 1–2 days (Mulhall et al., 2018); in a 2015 trial, 25 mg a day for 12 weeks raised testosterone in hypogonadal infertile men (Helo et al., 2015). The guideline lists visual symptoms, flushing, headache and abdominal discomfort among its side effects (Mulhall et al., 2018); zuclomiphene is thought to cause some of clomiphene's side effects (Wiehle et al., 2013).
• Female ovulation induction (Clomid) — Clomiphene, the two-isomer mixture, was FDA-approved in 1967 (Drugs@FDA through openFDA, read October 18, 2026) to induce ovulation in women (Clomid label).

Reconstitution & Storage

Enclomiphene is a small-molecule oral drug. It is not lyophilized and does not require reconstitution. It is supplied as compounded oral capsules or tablets.

• No reconstitution required — Oral solid dosage form. It is not dissolved for injection.
• Absorption — Rapidly absorbed after an oral dose (Rodriguez et al., 2016).
• Tmax — 2–3 hours after a dose, measured after 6 weeks of daily dosing (Wiehle et al., 2013).
• Half-life — About 10 hours, against about 30 days for the cis-isomer zuclomiphene (Rodriguez et al., 2016); the 2013 study's authors give about 7 hours for enclomiphene (Wiehle et al., 2013).

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Side Effects & Risks

Its side-effect data come from the Phase 2 and Phase 3 trials; a 2016 review found few adverse effects but noted they had not been directly studied and that long-term effects are unknown (Rodriguez et al., 2016).

• Safety in the trials — Short-term safety in the early trials was equivalent to testosterone gel and placebo (Hill et al., 2009). In Repros’s six-month open-label safety study (ZA-300), 499 men started on 12.5 mg a day, and those whose morning testosterone stayed below 450 ng/dL at week 6 or 16 were raised to 25 mg (European Medicines Agency, 2018; 283 men in the 25 mg group of its ClinicalTrials.gov record, NCT01534208). 393 finished it, 23 stopped because of adverse events, and 15 of the 490 whose safety was reported had a serious adverse event during treatment or the 8 weeks after, among them a deep-vein thrombosis in each dose group, one of them with pulmonary emboli in both lungs (ClinicalTrials.gov NCT01534208, results posted July 24, 2014; European Medicines Agency, 2018). The study had no placebo group.
• Headache — Among the side effects reported in the Phase 2 and 3 trials (Rodriguez et al., 2016).
• Hot flashes / vasomotor symptoms — Listed for clomiphene, the two-isomer mixture: vasomotor flushes in 10.4% of women in its clinical studies (Clomid label), and flushing among its side effects in the AUA guideline (Mulhall et al., 2018). They are not among the side effects the 2016 review reports from the enclomiphene trials (Rodriguez et al., 2016), but the trials’ own records list them: ZA-300’s posted results count hot flushes in 2 of 207 men in its 12.5 mg group and 9 of 283 in its 25 mg group (ClinicalTrials.gov NCT01534208), and the EMA counts those judged at least possibly related in 1.1% of men on enclomiphene, against 0.5% on placebo and none on testosterone gel (European Medicines Agency, 2018).
• Mood changes — Depression is among clomiphene's side effects reported in under 1% of women, and no direct comparison of enclomiphene with clomiphene had been published by 2016 (Rodriguez et al., 2016).
• Visual disturbances — The clomiphene label warns of blurring, spots or flashes, more often with higher total doses or longer use and sometimes lasting or irreversible, and tells patients with any visual symptoms to stop treatment and have a complete eye examination (Clomid label). The 2013 enclomiphene study screened men with a slit-lamp eye exam and excluded men with cataracts (Wiehle et al., 2013).
• Estradiol elevation — Among the side effects reported in the trials; in men, about 80% of circulating estradiol is made from testosterone (Rodriguez et al., 2016).
• GI tolerability — Abdominal discomfort is among the side effects reported in the trials (Rodriguez et al., 2016).
• Venous thromboembolism — The EMA's committee named a risk of venous thromboembolism (blood clots in the veins) with enclomiphene as one of its two main concerns when it recommended refusing authorization in 2018 (European Medicines Agency, 2018). The AUA guideline lists thromboembolic events, including deep venous thrombosis and stroke, for tamoxifen, another SERM (Mulhall et al., 2018).
• Bone effects (long-term) — Estrogens play a role in bone turnover in men (Rodriguez et al., 2016). Over 6 weeks, enclomiphene did not significantly change bone markers (Wiehle et al., 2013). Repros’s one-year study of bone mineral density (ZA-303) was single-blind against a placebo group that was not randomized: men who did not meet its low-testosterone criterion were put on placebo (ClinicalTrials.gov NCT01619683). The registry lists 300 men; the EMA’s results table counts 317, 122 on 12.5 mg, 91 on 25 mg and 104 on placebo. At 12 months, mean bone density at the total hip, the femoral neck and the spine had changed by less than 1% in every group; the placebo group lost more at the total hip (−0.75%, against −0.01% and −0.29% on enclomiphene), and spine density fell 0.82% on 12.5 mg (European Medicines Agency, 2018). The results are not posted on ClinicalTrials.gov, and no paper reporting them was found in PubMed (ClinicalTrials.gov NCT01619683; searched October 17, 2026).
• Drug interactions — The label of clomiphene, the two-isomer mixture, says drug interactions with it have not been documented (Clomid label).
• WADA (S4.2) — The 2026 Prohibited List bans SERMs at all times and names clomifene, of which enclomiphene is one isomer (Prohibited List 2026).
• Contraindications — Enclomiphene has no FDA label and so no official contraindications. Its 2013 study excluded men with diabetes, cataracts, breast or prostate cancer, uncontrolled high blood pressure or a PSA above 3.6 ng/mL, among others (Wiehle et al., 2013). The clomiphene label lists liver disease, pregnancy, uncontrolled thyroid or adrenal disease and intracranial lesions such as pituitary tumors (Clomid label).

Bloodwork & Monitoring

No FDA label sets monitoring for enclomiphene. The AUA testosterone guideline sets follow-up testing for SERMs, the drug class it belongs to (Mulhall et al., 2018); the trials' own measurements follow.

• Baseline (AUA guideline) — Total testosterone on two separate early mornings, with LH; prolactin when LH is low or low-normal; FSH in men who want to keep their fertility, before a SERM, hCG or an aromatase inhibitor; hemoglobin and hematocrit; estradiol in men with breast enlargement; PSA in men over 40; HbA1c in middle-aged or older men with obesity, metabolic syndrome or long corticosteroid use (Mulhall et al., 2018).
• After starting (AUA guideline) — On clomiphene, the first follow-up test comes no sooner than four weeks after starting; on a SERM, LH is measured at four weeks in men whose testosterone stays low, and again if testosterone falls after an initial response; estradiol is optional (Mulhall et al., 2018).
• Once stable (AUA guideline) — Total testosterone every 6–12 months; the guideline notes anecdotal concerns that clomiphene's effect can fade over time (Mulhall et al., 2018).
• In the trials — The Phase 3 trials measured total testosterone, LH and FSH at baseline and after 16 weeks (Kim et al., 2016). The 2013 study sampled testosterone and LH hourly for 24 hours, tracked estradiol, IGF-1, TSH, ACTH, cortisol, lipids and bone markers, and screened men with a slit-lamp eye exam; one morning testosterone reading predicted the 24-hour average (Wiehle et al., 2013).
• Sperm count — The AUA guideline gives a semen analysis to men with a raised FSH (Mulhall et al., 2018). In the Phase 3 trials, men gave two semen samples at the start and two at the end; sperm concentration stayed in the normal range on enclomiphene and fell sharply on testosterone gel (Kim et al., 2016).
• Bone density (DXA) — Repros’s one-year study measured bone mineral density in men on enclomiphene and on a placebo they were not randomized to (ZA-303); the changes at 12 months were under 1% in every group (European Medicines Agency, 2018; ClinicalTrials.gov NCT01619683).
• Symptoms — None of the enclomiphene trials measured symptoms or quality of life with validated questionnaires (Rodriguez et al., 2016); the EMA gave this as one reason for its 2018 refusal (European Medicines Agency, 2018).

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References

1. Hill S, Arutchelvam V, Quinton R. Enclomiphene, an estrogen receptor antagonist for the treatment of testosterone deficiency in men. IDrugs. 2009;12(2):109-119. PMID: 19204885. (Foundational enclomiphene clinical pharmacology paper.)
2. Wiehle R, Cunningham GR, Pitteloud N, Wike J, Hsu K, Fontenot GK, Rosner M, Dwyer A, Podolski J. Testosterone restoration using enclomiphene citrate in men with secondary hypogonadism: a pharmacodynamic and pharmacokinetic study. BJU Int. 2013;112(8):1188-1200. PMC4155868. (PK/PD study; 48 men; 6 weeks.)
3. Kim ED, McCullough A, Kaminetsky J. Oral enclomiphene citrate raises testosterone and preserves sperm counts in obese hypogonadal men, unlike topical testosterone: restoration instead of replacement. BJU Int. 2016;117(4):677-685. PMID: 26496621. (Pivotal Phase 3 RCT data.)
4. Earl JA, Kim ED. Enclomiphene citrate: A treatment that maintains fertility in men with secondary hypogonadism. Expert Rev Endocrinol Metab. 2019;14(3):157-165. PMID: 31063005. (Modern clinical review.)
5. Kaminetsky J, Werner M, Fontenot G, Wiehle RD. Oral enclomiphene citrate stimulates the endogenous production of testosterone and sperm counts in men with low testosterone: comparison with testosterone gel. J Sex Med. 2013;10(6):1628-1635. PMID: 23530575.
6. Wiehle RD, Fontenot GK. Oral enclomiphene citrate lowers IGF-1 in men with secondary hypogonadism while raising testosterone: implications for cancer prevention. Cancer Res. 2013;73(8 Supplement):1326. DOI: 10.1158/1538-7445.am2013-1326. (AACR abstract.)
7. Rodriguez KM, Pastuszak AW, Lipshultz LI. Enclomiphene citrate for the treatment of secondary male hypogonadism. Expert Opin Pharmacother. 2016;17(11):1561-1567. PMC5009465. (Comprehensive clinical review.)
8. Helo S, Ellen J, Mechlin C, Feustel P, Grossman M, Ditkoff E, McCullough A. A randomized prospective double-blind comparison trial of clomiphene citrate and anastrozole in raising testosterone in hypogonadal infertile men. J Sex Med. 2015;12(8):1761-1769. PMID: 26176805.
9. Bhasin S, Brito JP, Cunningham GR, Hayes FJ, Hodis HN, Matsumoto AM, Snyder PJ, Swerdloff RS, Wu FC, Yialamas MA. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2018;103(5):1715-1744. PMID: 29562364.
10. Drugs.com. Androxal Development History (FDA Approval: No; CRL December 2015). drugs.com/history/androxal.html.
11. European Medicines Agency. Assessment report: EnCyzix (enclomifene), procedure EMEA/H/C/004198/0000, refusal of the marketing authorisation. EMA/88321/2018, January 25, 2018. https://www.ema.europa.eu/en/documents/assessment-report/encyzix-epar-public-assessment-report_en.pdf. Read October 17, 2026.
12. Adashi EY. Clomiphene citrate: mechanism(s) and site(s) of action—a hypothesis revisited. Fertil Steril. 1984;42(3):331-344. PMID: 6432584.
13. Guay AT, Jacobson J, Perez JB, Hodge MB, Velasquez E. Clomiphene increases free testosterone levels in men with both secondary hypogonadism and erectile dysfunction: who does and does not benefit? Int J Impot Res. 2003;15(3):156-165. DOI: 10.1038/sj.ijir.3900981.
14. FDA. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the FD&C Act (503A categories list), versions updated April 22, 2026 and May 14, 2026. fda.gov/media/94155/download. The May 14 version read October 18, 2026.
15. WADA Prohibited List 2026. World Anti-Doping Agency. wada-ama.org.
16. ClinicalTrials.gov NCT01993212, NCT01993225 — Repros Phase 3 ZA-304 / ZA-305 trials.
17. Mulhall JP, Trost LW, Brannigan RE, Kurtz EG, Redmon JB, Chiles KA, Lightner DJ, Miner MM, Murad MH, Nelson CJ, Platz EA, Ramanathan LV, Lewis RW. Evaluation and Management of Testosterone Deficiency: AUA Guideline. J Urol. 2018;200(2):423-432. PMID: 29601923.
18. Cosette Pharmaceuticals. Clomid (clomiphene citrate) tablets prescribing information. DailyMed set ID 2ca373c1-4dba-4126-8616-5c533d606fe5 (version effective January 31, 2025). dailymed.nlm.nih.gov. Read October 4, 2026.
19. World Anti-Doping Agency. Prohibited List 2027 (in effect January 1, 2027), French edition with track changes, August 26, 2026, and Summary of Major Modifications and Explanatory Notes, 2027 Prohibited List, August 17, 2026: wada-ama.org/sites/default/files/2026-09/2027list_final_fr_track_changes_26_august_2026.pdf and 2027_list_explanatory_note_en_final_17_august_2026_1.pdf, read October 12, 2026 in the Internet Archive’s copies captured October 9, 2026 (web.archive.org). The List’s English edition was not available there and was not read.
20. ClinicalTrials.gov NCT01534208 — Repros ZA-300: An Open Label, Escalating Dose, 6 Month Phase III Safety Study Of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism. Completed October 2013; results first posted July 24, 2014. Read October 17, 2026.
21. ClinicalTrials.gov NCT01619683 — Repros ZA-303: A 12 Month, Single Blind, Placebo Controlled, Phase III Study to Assess the Effects of Enclomiphene Citrate Treatment On Bone Mineral Density in Men With Secondary Hypogonadism. Completed September 2014; no results posted. Read October 17, 2026.
22. Repros Therapeutics Inc. Repros Therapeutics Receives Complete Response Letter From FDA for Enclomiphene. Press release, December 1, 2015, filed with the SEC as Exhibit 99.1 to its Form 8-K. https://www.sec.gov/Archives/edgar/data/897075/000117184315006596/0001171843-15-006596.txt. Read October 18, 2026.
23. European Commission. Union Register of medicinal products for human use: EnCyzix (enclomifene), refused; Commission decision C(2018) 2187 of April 6, 2018, refusing the marketing authorisation. https://ec.europa.eu/health/documents/community-register/html/ho26523.htm. Read October 18, 2026.
24. FDA. Drugs@FDA through openFDA: Clomid (clomiphene citrate), NDA 016131, approved February 1, 1967, now discontinued; Clomid, ANDA 075528, Cosette; searches for enclomiphene (generic name, active ingredient) and Androxal (brand name): no application. https://api.fda.gov/drug/drugsfda.json?search=application_number:%22NDA016131%22+application_number:%22ANDA075528%22. Read October 18, 2026.
25. FDA. Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act (categories 1–3). Updated March 21, 2025. https://www.fda.gov/media/94164/download. Read October 18, 2026.
26. FDA. 503B Bulk Drug Substances List, updated August 21, 2023. https://www.fda.gov/drugs/human-drug-compounding/503b-bulk-drug-substances-list. Read October 18, 2026: five substances, no enclomiphene.

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