恩氯米芬(Enclomiphene citrate) - 药物靶点：ER_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Enclomid、enclomifene、enclomifene citrate

+ [10]

靶点

ER

作用方式

拮抗剂

作用机制

ERs拮抗剂(雌激素受体家族拮抗剂)

治疗领域

内分泌与代谢疾病皮肤和肌肉骨骼疾病泌尿生殖系统疾病+ [1]

在研适应症-

非在研适应症

代谢性骨病2型糖尿病性腺机能减退+ [6]

原研机构

Repros Therapeutics, Inc.

在研机构

Repros Therapeutics, Inc.

非在研机构

FERRING BVRenable Pharma Ltd.

权益机构-

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构/序列

分子式C32H36ClNO8

InChIKeyPYTMYKVIJXPNBD-BTKVJIOYSA-N

CAS号7599-79-3

关联

26

项与恩氯米芬相关的临床试验

NCT02651688

/ Completed临床2期

A Randomized, Double Blind, Placebo-Controlled, Multi-Center Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Body Composition and Metabolic Parameters With Diet and Exercise in Conjunction With Treatment With 12.5 mg or 25 mg Enclomiphene

The purpose of this study is to compare the effects of 12 months of treatment with enclomiphene 12.5 mg, 25 mg, or placebo capsules on body composition and metabolic parameters in overweight men with acquired hypogonadotropic hypogonadism [confirmed morning testosterone (T) ≤300 ng/dL] following a 6 month diet and 15 month exercise program.

开始日期2016-01-11

申办/合作机构

Repros Therapeutics, Inc.

NCT02274181

/ Completed临床1期

An Open-Label, Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of Radiolabeled Androxal in Healthy Male Subjects After Oral Administration

The purpose of this study is to investigate the route(s) of elimination and mass balance of enclomiphene after oral administration of a single 25 mg (approximately equivalent to [(
]) 500 nanocurie [nCi]) dose of [14C]Androxal in healthy adult male subjects.

开始日期2014-12-01

申办/合作机构

Repros Therapeutics, Inc.

[+1]

NCT02160704

/ Withdrawn临床2/3期IIT

PHASE 2b RANDOMIZED, PARALLEL, DOUBLE-BLIND, PLACEBO-CONTROLLED EXPLORATORY STUDY TO EVALUATE THE EFFICACY OF ANDROXAL IN IDIOPATHIC MALE INFERTILITY (PROTOCOL #01-14-40-08)

This is an exploratory, single center, randomized, parallel, double-blind placebo- and active-controlled trial in adult males ages 18 to 35 years of age who have male infertility of unknown cause. Approximately 50 men will be randomly assigned to one of two treatment groups according to a 1:1 ratio. About half of the men will receive 25mg Androxal and half of the men will receive a placebo (non-active pill) for 16 weeks. This study will last approximately 4 months and involve up to 7 visits.
The purpose of this study is to determine the effect the Androxal on sperm production.

开始日期2014-09-22

申办/合作机构

Baylor College of Medicine

100 项与恩氯米芬相关的临床结果

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100 项与恩氯米芬相关的转化医学

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100 项与恩氯米芬相关的专利（医药）

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164

项与恩氯米芬相关的文献（医药）

2025-12-01·Translational Andrology and Urology

Preserving spermatogenesis in testosterone deficiency: innovations in replacement and stimulatory therapies

Review

作者: Hochu, Gabrielle ; Kim, Edward ; Geyer-Kim, Isabella

The rising prevalence of testosterone deficiency has led to increased use of exogenous testosterone therapy, including among men desiring fertility. Conventional testosterone replacement therapies (TRT) restore serum testosterone but suppress gonadotropins, resulting in impaired spermatogenesis. Consequently, newer approaches aim to normalize testosterone levels while preserving fertility potential. Intranasal testosterone provides short-acting, pulsatile testosterone delivery that mimics physiologic diurnal variation. Studies demonstrate normalization of serum testosterone while maintaining follicle-stimulating hormone (FSH) and luteinizing hormone (LH) within reference ranges, supporting the potential for preserved spermatogenesis. Similarly, oral testosterone undecanoate formulations offer noninvasive administration and short-acting pharmacokinetics. Clinical data show maintenance of FSH and LH within normal limits, albeit reduced from baseline, suggesting possible fertility preservation-though data on semen parameters remain limited. Concomitant administration of low-dose human chorionic gonadotropin (hCG) with exogenous testosterone has been shown to sustain intratesticular testosterone (ITT) and spermatogenesis. Multiple studies demonstrate that hCG maintains sperm production even with full gonadotropin suppression from TRT. Finally, enclomiphene citrate, a purified trans-isomer of clomiphene, stimulates the hypothalamic-pituitary-gonadal (HPG) axis, increasing endogenous testosterone while maintaining spermatogenesis. This paper provides an updated overview of these evolving modalities and advances since our 2013 publication, highlighting short-acting testosterone delivery, concomitant gonadotropin support, and selective estrogen receptor modulation. Continued research with larger, long-term studies is essential to confirm their safety, efficacy, and fertility outcomes.

2025-01-01·Archives of Endocrinology Metabolism

Clomiphene or enclomiphene citrate for the treatment of male hypogonadism: a systematic review and meta-analysis of randomized controlled trials

Review

作者: Sande-Lee, Simone van de ; Hohl, Alexandre ; Pasqualotto, Eric ; Ferreira, Rafael Oliva Morgado ; Chavez, Matheus Pedrotti ; Ronsoni, Marcelo Fernando

OBJECTIVE:

This study aimed to evaluate the efficacy and safety of selective estrogen receptor modulators (SERMs), specifically clomiphene and enclomiphene, in treating men with functional hypogonadism.

MATERIALS AND METHODS:

A systematic search was conducted in PubMed, Embase, the Cochrane Library, and ClinicalTrials.gov for randomized controlled trials comparing SERMs with placebo, testosterone (T) gel, or human chorionic gonadotropin (hCG), up to July 2024. The primary endpoints were total testosterone (TT), follicle-stimulating hormone (FSH), and luteinizing hormone (LH). Weighted mean differences (MDs) and risk ratios (RRs) were calculated for continuous and binary endpoints, respectively, with 95% confidence intervals (CIs).

RESULTS:

SERM therapy significantly improved TT (MD: 273.76 ng/dL; 95% CI: 191.87-355.66 ng/dL; p < 0.01; I2 = 89%), LH (MD: 4.66 IU/L; 95% CI: 3.37-5.94 IU/L; p < 0.01; I2 = 55%), and FSH (MD: 4.59 IU/L; 95% CI: 2.88-6.30 IU/L; p < 0.01; I2 = 68%) compared to placebo. No significant difference in TT was observed between the SERM and T gel groups. TT levels were significantly higher with SERM therapy and the combined treatment of SERM and hCG compared to hCG alone (158 vs. 153 vs. 134 ng/dL, respectively; p < 0.002 for both comparisons).

CONCLUSION:

SERM therapy is associated with significantly improved levels of TT, LH, and FSH in hypogonadal men compared to placebo, and significantly enhanced levels of LH and FSH compared to T gel. The findings suggest that SERM therapy effectively increases TT levels in men with functional hypogonadism and should be considered as an alternative to T gel therapy.

2025-01-01·Archives of Endocrinology Metabolism

Response to the letter to the editor: Clomiphene or enclomiphene citrate for the treatment of male hypogonadism: a systematic review and meta-analysis of randomized controlled trials

Letter

作者: Sande-Lee, Simone van de ; Hohl, Alexandre ; Pasqualotto, Eric ; Ferreira, Rafael Oliva Morgado ; Chavez, Matheus Pedrotti ; Ronsoni, Marcelo Fernando

5

项与恩氯米芬相关的新闻（医药）

2025-12-19

·PRNewswire

Feel30 Launches Austin-Based Telehealth Platform for Evidence-Proven TRT & Integrated At-Home Phlebotomy Services

AUSTIN, Texas, Dec. 19, 2025 /PRNewswire/ -- Feel30 , a telehealth platform specializing in testosterone replacement therapy and men's hormone optimization, has introduced a care model designed to improve access to clinically supervised treatment. Based in Austin, the service provides evidence-based TRT, enclomiphene treatment, and erectile dysfunction medications prescribed by licensed U.S. clinicians, with medications fulfilled through licensed U.S. pharmacies. Continue Reading Feel30 was founded on 22nd February 2025, by entrepreneur Thomas Phillips, who sought to address common problems in traditional hormone care, including long wait times, multiple in-person lab visits, slow or delayed pharmacy compounding, confusing pricing with hidden fees, and rigid schedules. Feel30 launches national telehealth TRT with at-home nurse blood draws. Post this Internal data from Feel30's early patient population shows that 40% of men seek evaluation primarily due to sustained low energy compared to earlier stages of life, while 30% enroll after relocating to a new state and needing continuity of TRT care. Service features include transparent all-inclusive pricing, quarterly at-home nurse blood draws, home or in-clinic lab flexibility, unlimited clinician consultations, discreet pharmacy fulfillment, and scheduling on patients' terms. The initial laboratory panel costs $99 to $129 and includes the lab test, the at-home nurse visit or in-clinic option, the medical intake, and the clinician review. Ongoing treatment starts at $199 to $235 per month and includes medication, quarterly at-home nurse blood draws, unlimited clinician consultations, follow-up care, medication management, and discreet shipping. There are no upsells or hidden fees. The care process begins with a comprehensive blood panel to evaluate testosterone levels and related biomarkers. Patients can receive at-home nurse visits as early as the next day, with optional in-clinic laboratory testing available. Feel30's licensed clinicians review results and issue prescriptions only when medically appropriate and aligned with established guidelines. Most patients complete their initial evaluation within 48 to 72 hours. Feel30 is one of the only national TRT providers offering quarterly at-home phlebotomy included in the base membership price, positioning it as a leading option for men seeking convenient, medically supervised hormone therapy. According to established Endocrine Society guidelines, testosterone therapy should only be prescribed after laboratory testing confirms low testosterone. Testosterone levels naturally decline with age, and clinically low levels may be associated with symptoms like fatigue, reduced libido, decreased muscle mass, increased body fat, and lower motivation. Enclomiphene may be used to increase endogenous testosterone production while preserving fertility. "Many men experience delays in hormone evaluation because of limited appointment availability or the inconvenience of accessing laboratory services," said Anneliese Cadena, AGNP-C, board-certified Nurse Practitioner and consultant for Feel30. "Telehealth combined with at-home diagnostics allows timely evaluation and guideline-based prescribing with ongoing medical oversight." Telehealth continues to increase in men's hormone care as patients seek faster evaluation and more flexible access to licensed clinicians. Integrated care models allow clinicians to assess laboratory data remotely, prescribe treatment, and follow up with patients. Media Contact: Thomas Phillips, [email protected], 833-545-1589 **About Feel30** Feel30 is based in Austin, Texas. The platform provides evidence-based testosterone therapy, enclomiphene treatment, and men's health services with all-inclusive pricing, at-home lab testing with nurse visits, unlimited clinician support, and fast U.S. pharmacy fulfillment. The company's mission is to make evidence-based hormone care clearer, faster, and more accessible for busy men nationwide who refuse to wait. SOURCE Feel30 21% more press release views with Request a Demo

2025-09-10

·EndPoints

Hims expands into hormone health with men's testosterone treatment

Hims & Hers is launching men’s hormone health services, the company said Wednesday. To start, Hims will offer compounded enclomiphene, a treatment used to help men with low testosterone by inhibiting estrogen production. Next year, it plans to offer injectable and oral testosterone. It’s exclusively working with Marius Pharmaceuticals, which makes the oral testosterone medication Kyzatrex, to offer a Hims-labeled oral testosterone. With the launch of testosterone treatments, Hims joins a growing group of telehealth companies, including Hone Health, Henry Meds and independent clinics that have been prescribing testosterone online over the past few years. During Hims’ second-quarter earnings call, CEO Andrew Dudum highlighted hormonal health as one of the ways in which the company plans to grow its business to $6.5 billion in revenue by 2030, along with lab testing and international expansion. The new offering is the first time at-home lab testing is included in the launch of a new specialty. “The interrelationships between sexual health, obesity, low testosterone, are really profound, and we’re marching towards really holistic care that is comprehensive,” Peter Stahl, head of men’s health at Hims told Endpoints News. “Adding testosterone into our portfolio improves our ability to address some of the other really important conditions that we currently treat.” The expansion in 2026 into offering testosterone will also mark the first time Hims will offer a controlled substance. It’s listed as a schedule III drug by the government, meaning its distribution is limited because of the risk of abuse. “We’ve systematically built up a clinical quality and safety program over many years that I think is robust enough to support safe, effective and evidence-based controlled substance prescribing now,” Stahl said. Because it’s a controlled substance, it can often be hard to get prescribed testosterone during a traditional doctor’s office visit, he said. (This story is from our Health Tech newsletter. If you’d like to sign up, just click here .)

2025-09-10

·Firstwordpharma

Hims & Hers Health expands into testosterone therapy after Novo Nordisk breakup

Telehealth company Hims & Hers Health announced Wednesday that it is launching treatment for low testosterone. Effective immediately, providers on the Hims platform can prescribe personalised doses of a compounded version of the selective estrogen receptor modulator enclomiphene, either alone or combined with the erectile dysfunction medication tadalafil, for men experiencing sexual symptoms. Beginning next year, Hims will also offer Kyzatrex (testosterone undecanoate), an FDA-approved oral testosterone replacement therapy from Marius Pharmaceuticals.According to Hims, an estimated 20 million men in the US have low testosterone — a condition associated with fatigue, depression, reduced libido and an increased risk of serious health issues like heart disease, diabetes and cancer. Despite these risks, most men with low testosterone go untreated. "Low testosterone care has been stuck in the past, stigmatised, expensive and inaccessible for most men," said Andrew Dudum, founder and CEO of Hims & Hers. He added that the company aims to make treatment easily accessible and tailored to each patient's needs. To begin treatment, patients take an at-home blood test. Once results are available — typically within a few days — patients work with their provider to choose the best treatment plan, which may include ongoing at-home lab testing and provider check-ins, round-the-clock access to a care team, medication adjustments and educational resources available through the Hims app. Enclomiphene helps the body resume natural testosterone production without affecting fertility, according to Hims. The company also states that Kyzatrex restores testosterone levels in up to 96% of men, doubling free testosterone while maintaining a low side effect profile. "Marius developed Kyzatrex to modernise testosterone replacement therapy with an oral treatment backed by rigorous science and FDA approval," said Shalin Shah, CEO of Marius Pharmaceuticals. "Partnering with Hims & Hers allows us to bring this innovation to scale," he continued, adding that Hims' platform will help the drug reach millions of consumers. In addition to oral therapies, Hims plans to introduce injectable testosterone treatments through its digital platform in 2026.The expansion could serve as a new revenue-generating product line for the company as it distances itself from the regulatory uncertainties surrounding compounded weight-loss drugs. Hims took a huge financial hit after the FDA removed semaglutide from its shortage list, causing a sharp decline in sales of its compounded weight-loss offerings. It has also faced scrutiny from the FTC over its subscription practices and is battling investor lawsuits claiming the company misrepresented its financial status following its break-up with Novo Nordisk.

并购

100 项与恩氯米芬相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10876	-	-	DB06735

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
性腺机能减退	申请上市	欧盟	Renable Pharma Ltd.	2018-01-25
代谢性骨病	临床3期	美国	Repros Therapeutics, Inc.	2012-09-01
特发性低促性腺素性功能减退症	临床3期	美国	Repros Therapeutics, Inc.	2012-08-01
超重	临床3期	美国	Repros Therapeutics, Inc.	2012-08-01
继发性睾丸衰竭	临床3期	美国	Repros Therapeutics, Inc.	2006-03-01
不孕	临床3期	美国	FERRING BV	2005-02-01
肥胖	临床2期	美国	Repros Therapeutics, Inc.	2016-01-11
低睾酮水平	临床2期	美国	Repros Therapeutics, Inc.	2011-07-01
2型糖尿病	临床2期	美国	Repros Therapeutics, Inc.	2010-10-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02651688 (CTgov)	临床2期	特发性低促性腺素性功能减退症 \| 肥胖	50	Enclomiphene (Enclomiphene 12.5 mg)	築鹹夢廠襯鹽餘衊夢顧(廠糧糧顧膚廠鑰蓋觸鏇) = 醖艱襯糧廠鬱觸遞遞窪壓壓餘憲構網願獵艱醖 (繭鹹蓋範觸鑰範選憲鹹, 7.08) 更多	-	2019-06-14
				Enclomiphene (Enclomiphene 25 mg)	築鹹夢廠襯鹽餘衊夢顧(廠糧糧顧膚廠鑰蓋觸鏇) = 構範觸齋鏇簾齋膚糧鑰壓壓餘憲構網願獵艱醖 (繭鹹蓋範觸鑰範選憲鹹, 7.88) 更多
NCT01984398 (CTgov)	临床1期	-	16	Androxal (12.5 mg Androxal Formulation A)	齋憲夢繭範鏇窪築衊鹽(築鹽構範繭遞壓鏇窪簾) = 糧壓範簾顧醖膚繭窪築膚獵觸構夢觸簾顧膚廠 (製鏇憲衊壓積艱選鑰獵, 0.349) 更多	-	2019-05-06
				Androxal (25 mg Androxal Formulation A)	齋憲夢繭範鏇窪築衊鹽(築鹽構範繭遞壓鏇窪簾) = 壓淵艱餘夢艱鏇構齋製膚獵觸構夢觸簾顧膚廠 (製鏇憲衊壓積艱選鑰獵, 0.74) 更多
NCT01386606 (CTgov)	临床2期	继发性睾丸衰竭	60	enclomiphene citrate (Androxal 6.25 mg)	網繭鹽廠鑰壓鹹鹹壓膚(遞築糧鹽壓築艱範製齋) = 簾積夢簾願鑰鏇醖襯廠鑰膚醖糧範衊糧鑰積網 (廠壓鑰構壓齋餘範衊觸, 80.3) 更多	-	2015-09-23
				enclomiphene citrate (Androxal 12.5 mg)	網繭鹽廠鑰壓鹹鹹壓膚(遞築糧鹽壓築艱範製齋) = 遞鑰夢壓蓋衊壓膚遞膚鑰膚醖糧範衊糧鑰積網 (廠壓鑰構壓齋餘範衊觸, 172.1) 更多
NCT01532414 (CTgov)	临床3期	继发性睾丸衰竭 \| 特发性低促性腺素性功能减退症 \| 超重	151	Placebo (Placebo)	糧艱鹹夢壓繭艱願襯鏇 = 膚憲壓遞網獵簾製鏇簾鑰蓋醖顧網獵願窪艱構 (膚齋糧範選顧襯積鏇鬱, 網顧願襯鏇壓壓壓夢鏇 ~ 鹹鹹獵製願鹽糧糧衊壓) 更多	-	2015-05-27
				Androxal (Androxal 12.5 mg)	艱襯淵鏇鹽蓋壓製淵獵(觸遞鏇壓鹽簾窪艱選築) = 築繭願獵遞選選觸鏇簾襯壓淵醖夢積襯選鏇憲 (鹽鑰構製範壓齋顧願齋, 廠構醖製網糧繭餘範網 ~ 願選艱願簾範遞襯築構) 更多
NCT01739595 (CTgov)	临床3期	继发性睾丸衰竭 \| 特发性低促性腺素性功能减退症 \| 超重	181	Placebo (Placebo)	鹽鏇鹹鑰遞蓋壓選憲構 = 鏇構鹹選鏇夢夢遞艱繭獵艱構選淵餘鏇網淵構 (繭醖夢廠構構憲鏇鏇簾, 範衊構鹽蓋鬱鹹製膚選 ~ 鹹齋鑰簾選淵夢衊鑰淵) 更多	-	2015-05-27
				enclomiphene citrate (Androxal 12.5 mg)	夢襯製糧鑰餘顧製遞餘(鹽範觸糧夢繭蓋齋範範) = 壓顧夢顧顧鹹鑰餘鬱蓋齋廠鹽獵鑰餘構願願鹹 (獵製齋願遞簾積淵膚獵, 願窪襯壓繭範積糧觸鑰 ~ 鏇糧糧憲願壓壓獵鹽願) 更多
NCT01959685 (CTgov)	临床1期	-	9	Androxal	鏇壓膚淵選構獵鏇齋齋(鬱醖構蓋鏇簾獵衊範蓋) = 構鑰鏇選鑰窪獵窪鑰膚鏇製構憲衊廠蓋醖鑰廠 (憲築繭顧廠鹽淵願網廠, 3.1) 更多	-	2014-08-11
NCT01270841 (CTgov)	临床2期	继发性睾丸衰竭	83	Placebo (Placebo)	範壓鬱夢憲淵願鹽範鹹(獵餘鹹糧鏇糧願餘窪蓋) = 襯餘蓋襯鹽積壓鹽壓艱艱艱範壓壓壓範製積築 (醖膚淵餘襯淵簾選壓蓋, 47.5) 更多	-	2014-07-28
				topical testosterone (Testim (Topical Testosterone))	範壓鬱夢憲淵願鹽範鹹(獵餘鹹糧鏇糧願餘窪蓋) = 夢膚鏇願餘網鏇壓憲鑰艱艱範壓壓壓範製積築 (醖膚淵餘襯淵簾選壓蓋, 292.3) 更多
NCT01191320 (CTgov)	临床2期	2型糖尿病 \| 继发性睾丸衰竭 \| 特发性低促性腺素性功能减退症	102	Placebo (Placebo)	觸淵顧範選膚壓構鏇顧(齋願觸鏇鏇憲壓選鬱艱) = 淵遞鏇醖廠構衊鏇醖窪願窪膚壓鹽築製製糧顧 (製顧糧顧襯築淵鏇憲壓, 0.012) 更多	-	2014-07-24
				Androxal (Androxal 12.5 mg)	觸淵顧範選膚壓構鏇顧(齋願觸鏇鏇憲壓選鬱艱) = 製顧簾觸鬱鏇壓簾鑰艱願窪膚壓鹽築製製糧顧 (製顧糧顧襯築淵鏇憲壓, 0.015) 更多
NCT01534208 (CTgov)	临床3期	继发性睾丸衰竭	499	Androxal (Androxal 12.5 mg)	鑰獵鹽廠鑰簾壓觸衊鹽(窪糧鑰鏇廠壓夢鑰夢窪) = 網糧糧蓋鏇鹹蓋網遞襯鑰願製鑰範簾製夢簾範 (遞襯淵製襯鏇醖築鏇壓, 141.4) 更多	-	2014-07-24
				Androxal (Androxal 25 mg)	鑰獵鹽廠鑰簾壓觸衊鹽(窪糧鑰鏇廠壓夢鑰夢窪) = 憲醖壓鹽膚顧鹽窪築鹽鑰願製鑰範簾製夢簾範 (遞襯淵製襯鏇醖築鏇壓, 154.7) 更多