非那雄胺(Finasteride) - 药物靶点：5α-reductase_在研适应症：雄激素脱发，脱发，前列腺增生症_专利_临床

概要

基本信息

简介Finasteride，商业名称为PROSCAR®，是一种5α-还原酶抑制剂药物，主要用于治疗男性前列腺增生症（BPH），改善症状、降低急性尿潴留的风险以及降低需要手术（包括经尿道前列腺电切术和摘除前列腺）的风险。这种药物于1992年在美国获得首次批准，由默克公司生产。PROSCAR (finasteride)是一种合成的4-氮杂甾体化合物，是一种特异性的类固醇II型5α-还原酶抑制剂，可抑制细胞内的酶将雄激素睾酮转化为5α-二氢睾酮（DHT）。

药物类型

小分子化药

别名

(5alpha,17beta)-(1,1-Dimethylethyl)-3-oxo-4-azaandrost-1-ene-17-carboxamide、Finasteride (JAN/USP/INN)、非那雄胺（奎安）

+ [47]

靶点

5α-reductase

作用机制

5α-reductase抑制剂(类固醇5α还原酶抑制剂)

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

Almirall Hermal GmbH科笛生物醫藥（香港）有限公司

+ [4]

非在研机构

Polichem SA (Switzerland)

南京圣和药业股份有限公司Merck Frosst Canada Ltd.

+ [1]

最高研发阶段批准上市

首次获批日期

美国 (1992-06-19),

前列腺增生症

最高研发阶段(中国)批准上市

特殊审评-

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结构

分子式C23H36N2O2

InChIKeyDBEPLOCGEIEOCV-WSBQPABSSA-N

CAS号98319-26-7

关联

137

项与非那雄胺相关的临床试验

NCT06590779 / Not yet recruitingN/A

Evaluation of the Benefits of a Cosmetic Anti-hair Loss Lotion Applied in Combination With Finasteride in Male Subjects With Hair Loss: Investigator-blinded, Randomized, Multi-center Study Performed Under Dermatological Control

Androgenetic alopecia (AGA), also known as androgenic alopecia or male pattern baldness, is the most common type of progressive hair loss. AGA is a polygenetic condition with varying severity, age of onset, and scalp location of hair loss. In men, hair loss typically involves the temporal and vertex region while sparing the occipital region: the characteristic "horseshoe" pattern. Incidence and prevalence of AGA depend on age and race.
Vichy has developed a new cosmetic anti hair loss lotion with the aim of acting on androgenic alopecia. The aim is to improve the efficacy on hair loss of the association of the lotion with finasteride versus finasteride alone.
The primary objective of this investigator-blinded, randomized multi-center study is to quantitatively evaluate, using the phototrichogram method, the efficacy of a lotion associated with finasteride versus finasteride alone on hair growth parameters in male subjects with androgenetic alopecia.

开始日期2024-11-02

申办/合作机构

Cosmetique Active International

[+2]

TCTR20240926001 / Not yet recruiting临床3期IIT

Efficacy and safety of different doses of topical finasteride in the treatment of male androgenetic alopecia

开始日期2024-09-30

申办/合作机构-

TCTR20240816002 / Not yet recruiting临床2/3期IIT

EFFICACY AND SAFETY OF TOPICAL FINASTERIDE 0.5% SOLUTION ONCE DAILY VERSUS TWICE DAILY IN THE TREATMENT OF MALE ANDROGENETIC ALOPECIA

开始日期2024-08-30

申办/合作机构-

100 项与非那雄胺相关的临床结果

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100 项与非那雄胺相关的转化医学

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100 项与非那雄胺相关的专利（医药）

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3,081

项与非那雄胺相关的文献（医药）

2025-02-01·PROSTATE

Does size matter? A single institution's comparison of Aquablation in prostates greater than or less than 150 mL

Article

作者: Hafron, Jason ; Gangwish, David ; Kuperus, Joshua ; Palmateer, Greg ; Horning, Paul ; Ringler, Renee ; Peters, Kenneth M. ; Zwaans, Bernadette M. M.

Abstract:

Background:

Surgical management options for lower urinary tract symptoms due to benign prostatic hypertension have remained limited in prostates of large volume. The advent of the Aquablation has created a potential minimally invasive option for treatment in prostates of all volumes. Thus, this study aims to evaluate outcomes and complications of Aquablation in clinical practice based on prostate volume.

Methods:

Collected variables included adverse events with Clavien‐Dindo classifications, transfusion rates, surgical retreatment rates, continued medication use postoperatively, and International Prostate Symptom Score (IPSS) with Quality‐of‐Life indicator. Aquablations were stratified by preoperative prostate volume.

Results:

One hundred seventy‐four men were included in the study. The average postop decrease in IPSS was 10.28, with a 2.02 point decrease in Quality‐of‐Life at 1 year. Postop increase in peak urinary flow rate was 7.65 mL/s for an average of 16.44 mL/s. Hemoglobin drop average was 1.78 g/dL, but only 2.3% of patients required a transfusion. 12.9% of patients required surgical retreatment. Six months after Aquablation, 22.9% and 12.9% of patients continued taking Alpha‐blockers and Androgen receptor inhibitors, respectively. Adverse events occurred in 33 patients (19.0%). Eighteen patients were excluded from secondary analysis due to unrecorded prostate volume, leaving 123 with volumes <150 mL and 33 with volumes ≥150 mL. Groups were comparable with respect to length of stay, adverse events, blood transfusion, IPSS with Quality‐of‐Life indicator preoperative and postoperative, postop peak urinary flow, and postop alpha‐blocker use. Larger prostates had a higher rate of adverse events, retreatment, postop hemoglobin drop, and postop use of finasteride.

Conclusions:

Aquablation is a viable treatment option for benign prostatic hyperplasia. Efficacy, safety, subjective outcomes, and adverse event rates were not impacted by prostate volume. However, size does matter as prostates ≥150 mL had higher surgical retreatment rates and postop finasteride use.

2025-01-01·COLLOIDS AND SURFACES B-BIOINTERFACES

Facile fabrication of cedrol nanoemulsions with deep transdermal delivery ability and high safety for effective androgenic alopecia treatment

Article

作者: He, Yibo ; Guo, Liang ; Wang, Shaojun ; Cai, Guoqiang ; Han, Honghong ; Xu, Jian ; Cui, Ruiyao ; Cao, Peng ; Ding, Xiaofeng ; Li, Dawei ; Chen, Bin ; Chen, Jing

The successful treatment of androgenic alopecia (AGA) hinges on an effective transdermal drug delivery strategy, a challenge that requires urgent attention. In this study, we introduce a novel approach utilizing cedrol nanoemulsions (CD-NEs) for AGA treatment. Our findings demonstrate that cedrol (CD) effectively inhibits the expression of 5α-reductase 2 (5αR2), akin to the FDA-approved drug finasteride, while also surpassing it in terms of promoting cell proliferation. Through formulation optimization, we have developed stable CD-NEs suitable for large-scale production. Experimental and molecular dynamics simulations further reveal that CD-NEs enhance transdermal penetration by altering lipid organization, facilitating CD delivery to deeper skin layers via a trans-epidermal pathway. In vivo studies conducted on AGA model C57BL/6 mice demonstrate that CD-NEs significantly promote hair follicle regeneration, accelerating the transition of hair follicles from the telogen phase to the anagen phase. Moreover, CD-NEs treatment leads to a significant reduction in dihydrotestosterone (DHT) levels in the skin while maintaining stasis levels in serum, underscoring its efficacy in targeting androgenetic pathways with high safety. This comprehensive analysis sheds light on the efficacy and mechanism of action of CD-NEs in hair regeneration, offering valuable insights for future clinical applications in AGA treatment.

2025-01-01·World Journal of Mens Health

Comparison of Finasteride and Dutasteride on Risk of Prostate Cancer in Patients with Benign Prostatic Hyperplasia: A Pooled Analysis of 15 Real-world Databases

Article

作者: Kim, Do Kyung ; Cha, Jae Myung ; Ha, Ji Yong ; Kim, Kyung-Jin ; Hah, Yoon Soo ; Yang, Hyeon-Jong ; Yang, Dae Yul ; Seo, Won-Woo ; Rhee, Sang Youl ; Park, Rae Woong ; Jeong, Chang Won

PURPOSE:

Finasteride and dutasteride are used to treat benign prostatic hyperplasia (BPH) and reduce the risk of developing prostate cancer. Finasteride blocks only the type 2 form of 5-alpha-reductase, whereas dutasteride blocks both type 1 and 2 forms of the enzyme. Previous studies suggest the possibility that dutasteride may be superior to finasteride in preventing prostate cancer. We directly compared the effects of finasteride and dutasteride on the risk of prostate cancer in patients with BPH using a pooled analysis of 15 real-world databases.

MATERIALS AND METHODS:

We conducted a multicenter, cohort study of new-users of finasteride and dutasteride. We include patients who were prescribed 5 mg finasteride or dutasteride for the first time to treat BPH and had at least 180 days of prescription. We excluded patients with a history of prostate cancer or a prostate-specific antigen level ≥ 4 ng/mL before the study drug prescription. Cox regression analysis was performed to examine the hazard ratio (HR) for prostate cancer after propensity score (PS) matching.

RESULTS:

A total of 8,284 patients of new-users of finasteride and 8,670 patients of new-users of dutasteride were included across the 15 databases. In the overall population, compared to dutasteride, finasteride was associated with a lower risk of prostate cancer in both on-treatment and intent-to-treat time-at-risk periods. After 1:1 PS matching, 4,897 patients using finasteride and 4,897 patients using dutasteride were enrolled in the present study. No significant differences were observed for risk of prostate cancer between finasteride and dutasteride both on-treatment (HR=0.66, 95% confidence interval [CI]: 0.44-1.00; p=0.051) and intent-to-treat time-at-risk periods (HR=0.87, 95% CI: 0.67-1.14; p=0.310).

CONCLUSIONS:

Using real-world databases, the present study demonstrated that dutasteride was not associated with a lower risk of prostate cancer than finasteride in patients with BPH.

219

项与非那雄胺相关的新闻（医药）

2024-12-12

·GlobeNewswire-Health Care

Onconetix, Inc. Announces Receipt of Notice from Nasdaq Regarding Late Filing of Quarterly Report on Form 10-Q and Subsequent Filing

Cincinnati, OH, Dec. 12, 2024 (GLOBE NEWSWIRE) -- Onconetix, Inc. (NASDAQ: ONCO) (the “Company”) announced that it received a letter from The Nasdaq Capital Market (“Nasdaq”) on December 6, 2024 indicating that the Company’s failure to file its Quarterly Report on Form 10-Q for the period ended September 30, 2024 (the “Form 10-Q”) is in violation of Nasdaq’s continued listing requirements under Nasdaq Listing Rule 5250(c)(1) (the “Rule”). On December 10, 2024, the Company filed the Form 10-Q with the Securities and Exchange Commission. This announcement is made in compliance with Nasdaq Listing Rule 5810(b), which requires prompt disclosure of receipt of a deficiency notification. About Onconetix, Inc.: Onconetix is a commercial stage biotechnology company focused on the research, development and commercialization of innovative solutions for men’s health and oncology. Through our recent acquisition of Proteomedix, we own Proclarix®, an in vitro diagnostic test for prostate cancer originally developed by Proteomedix and approved for sale in the European Union (“EU”) under the In Vitro Diagnostic Regulation (“IVDR”). We also own ENTADFI, an FDA-approved, once daily pill that combines finasteride and tadalafil for the treatment of benign prostatic hyperplasia (“BPH”), a disorder of the prostate. For more information, visit www.onconetix.com. Contact Information: Onconetix, Inc.201 E. Fifth Street, Suite 1900Cincinnati, OH 45202Phone: (513) 620-4101 Investor Contact Information: Onconetix Investor RelationsEmail: investors@onconetix.com

并购诊断试剂

2024-12-12

·浙江大学药学院

浙江大学药学院研究团队联合开发新型非侵入式雄激素受体降解剂用于脱发治疗

根据国家卫健委的最新数据显示，截至目前，我国脱发人数已超过2.5亿。脱发主要可分为三种类型：雄激素性脱发（Androgenetic Alopecia, AGA）、斑秃（Alopecia Areata, AA）和化疗诱发的脱发（Chemotherapy-Induced Alopecia, CIA），其中AGA是导致男性和女性脱发的最常见原因。目前，AGA的确切病理机制尚未完全阐明。已有研究表明，雄激素受体（Androgen Receptor, AR）的表达水平升高及其活性增强与AGA的发生和发展密切相关。在过去数十年中，已经开发出多种AR拮抗剂用于前列腺癌的治疗，其中部分药物也被应用于AGA的治疗，包括RU58841、氟罗地尔（Finasteride）和KX-826等。然而，目前这些药物均处于临床研究阶段，临床上仍缺乏有效的治疗药物。近日，浙江大学药学院董晓武团队与高建青团队联合在《Journal of Medicinal Chemistry》上发表了题为“Discovery of a Novel Non-invasive AR PROTAC Degrader for the Topical Treatment of Androgenetic Alopecia”的研究成果。该研究基于分子结构特征策略，开发了一种新型的AR PROTAC（Proteolysis Targeting Chimeras）分子，通过酊剂外用治疗的方式实现了对AGA的有效治疗。研究团队首先预测了与化合物皮肤驻留性质相关的理化性质参数，对100多种模型分子进行了参数预测与排序，并测试了排名靠前的模型分子的皮肤驻留率。基于模型分子的皮肤驻留率与其结构特征之间的相关性，研究团队总结了相应的皮肤驻留与化学结构特征的规律。随后，研究团队开展了AR PROTAC分子的设计、合成及生物活性筛选。优选的先导分子PROTAC-C6表现出强效的AR降解活性。药代动力学研究显示，降解剂C6在局部外用治疗中表现出优异的皮肤富集能力，且其在全身血液循环及其他器官组织中的分布较低，具有减少全身性副作用的潜力。最后，研究团队在小鼠AGA模型中验证了降解剂C6的酊剂外用治疗成功实现了对AGA的有效治疗。新型非侵入式AR PROTAC用于AGA治疗示意图本研究的创新点在于基于结构特征提取的药物设计与局部制剂递送的交叉融合，首次开发了一种新型非侵入式的AR PROTAC药物，成功实现了对AGA的有效治疗。该策略不仅促进了PROTAC药物在AGA治疗中的潜力开发，还改善了患者的依从性，减少了可能存在的副作用，为AGA的治疗提供了新的策略。此外，本研究证实了PROTAC通过局部给药在治疗皮肤疾病中的良好潜力，为后续开发针对其他靶点的具有良好皮肤驻留性质的PROTAC药物提供了新思路，并为多种皮肤疾病的治疗提供了一种新型的治疗选择。浙江大学药学院为本论文的第一署名单位，浙江大学药学院硕士研究生毛新飞、博士研究生胡蔚同和博士研究生武明飞为共同第一作者，浙江大学董晓武教授、高建青教授和车金鑫特聘研究员为共同通讯作者。供稿：药物发现与设计研究所修稿：金成庆审稿：王毅扫码关注浙江大学药学院

蛋白降解靶向嵌合体临床结果

2024-12-11

·丁香园

时隔 10 年更新！中国雄激素秃发诊疗指南发布

12 月 5 日，中华医学会皮肤性病学分会毛发学组和中国康复医学会皮肤病康复专业委员会毛发疾病康复学组，根据雄激素性秃发最新诊疗相关循证医学证据，对 2014 版中国雄激素性秃发诊疗指南进行了修订，形成了 2023 版指南。新版指南结合近年来国内外进展对 AGA 的诊疗指南进行了修订，内容包括 AGA 的病因、发病机制、诊断、严重性评估、鉴别诊断、治疗与管理，对每种治疗及推荐等级以及注意事项进行了详细描述，强调早期治疗、规范治疗与长期治疗。以下为指南重点： 1、病因及发病机制 2、诊断及鉴别诊断 3、治疗 AGA 呈慢性渐进性过程，早期诊断和早期治疗十分重要系统药物治疗： ▶ 非那雄胺 ▶ 螺内酯 ▶ 孕激素类药物 ▶ 低剂量米诺地尔外用药物： ▶米诺地尔 ▶抗雄激素药物物理治疗： ▶微针治疗 ▶低能量激光治疗其他治疗： ▶富血小板血浆 ▶自体毛发移植插图、内容来源：中国雄激素秃发诊疗指南策划：ZJUN｜监制：z_popeye

放射疗法

100 项与非那雄胺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00321	非那雄胺	G04CB01 D11AX10	DB01216

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
雄激素脱发	日本	Organon & Co.	2005-10-11
脱发	美国	Organon & Co.	1997-12-19
前列腺增生症	美国	Organon & Co.	1992-06-19

未上市

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
男性雄激素源性脱发	临床3期	比利时	Polichem SA (Switzerland)	2016-08-02
男性雄激素源性脱发	临床3期	德国	Polichem SA (Switzerland)	2016-08-02
男性雄激素源性脱发	临床3期	匈牙利	Polichem SA (Switzerland)	2016-08-02
男性雄激素源性脱发	临床3期	俄罗斯	Polichem SA (Switzerland)	2016-08-02
男性雄激素源性脱发	临床3期	西班牙	Polichem SA (Switzerland)	2016-08-02
血尿	临床2期	加拿大	Merck Frosst Canada Ltd.	2008-03-01
血精	临床2期	加拿大	Merck Frosst Canada Ltd.	2008-03-01

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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


THU372 (ENDO2023)	N/A	-	-	Finasteride	蓋築膚遞獵顧窪範網襯(構齋繭壓夢鹽網製襯襯) = 築糧醖齋顧製選蓋製廠範選構襯鹹艱糧餘襯遞 (築蓋製壓範餘衊廠廠構 )	不佳	2023-10-05
NCT02248701 (CTgov)	临床2期	性腺机能减退 \| 男性生殖器官疾病 \| 脊髓损伤	33	Finasteride+Testosterone Enanthate (Testosterone Enanthate, Finasteride)	壓窪鹽獵壓鏇構鹽獵壓(願廠築廠膚夢製艱齋積) = 範網膚鏇齋顧選顧觸艱願築築網餘選糧繭夢鏇 (鏇範蓋網艱鑰壓願蓋淵, 夢鏇網餘築淵餘夢鹽夢 ~ 廠淵憲廠艱繭範餘壓簾) 更多	-	2023-09-29
				Placebo pill (Placebo Treatment)	壓窪鹽獵壓鏇構鹽獵壓(願廠築廠膚夢製艱齋積) = 憲遞衊艱繭襯夢壓範顧願築築網餘選糧繭夢鏇 (鏇範蓋網艱鑰壓願蓋淵, 齋糧築醖獵淵齋鏇糧鑰 ~ 顧製簾壓廠糧衊夢齋衊) 更多
WCD2023	N/A	雄激素脱发	28	Oral Minoxidil (2.5MG)	遞鑰壓艱網衊遞觸鬱鹽(繭壓鏇衊夢壓襯醖顧廠) = 鹽蓋齋鹽廠範鬱遞衊淵繭鹹觸繭築築繭襯選廠 (積範顧繭憲鹹積夢憲憲 )	-	2023-07-03
				Oral Finasteride (1MG)	遞鑰壓艱網衊遞觸鬱鹽(繭壓鏇衊夢壓襯醖顧廠) = 憲鹽廠網願選繭鹹憲鹽繭鹹觸繭築築繭襯選廠 (積範顧繭憲鹹積夢憲憲 )
EURETINA2022	N/A	中心性浆液性脉络膜视网膜病变	-	Finasteride	壓積襯選鹽艱憲鹽繭積(繭夢壓築醖選齋壓艱鹹) = 築醖鬱選獵鹹獵鬱鏇鹽襯艱願艱鑰淵壓鹹網選 (壓鬱積蓋鬱廠顧鏇觸鑰 )	-	2022-09-01
MP38-07 (AUA2022)	N/A	性功能障碍 DHT \| testosterone \| calculated free T	91	Men with persistent sexual dysfunction after discontinuation of Finasteride	繭觸觸積獵製鹹獵遞構(網遞壓鏇廠窪憲範鏇糧) = 壓築鹹積築衊積憲蓋鹹廠糧鹽廠鹽鏇糧願築窪 (選獵襯衊築壓艱鬱蓋願 ) 更多	-	2022-05-01
ARVO2022	N/A	干眼综合征	116	Finasteride 1 mg or 2.5 mg	願鹹獵鹽窪夢遞艱構艱(積窪夢壓繭憲夢願糧鹽) = 製顧襯繭襯獵顧構壓鹽鬱築範網築構襯淵餘積 (淵築憲選願壓築鹹範餘 ) 更多	-	2022-05-01
				Finasteride 5 mg	願鹹獵鹽窪夢遞艱構艱(積窪夢壓繭憲夢願糧鹽) = 鏇餘鹽願夢窪艱齋壓襯鬱築範網築構襯淵餘積 (淵築憲選願壓築鹹範餘 ) 更多
NCT01342367 (Prospective Trial Of Oral-Only Hormonal Therapy With Radiation, CTgov)	N/A	非转移性前列腺癌	74	bicalutamide+goserelin+leuprolide (SOC Cohort)	獵築顧壓蓋顧鬱壓簾願(顧鹹衊築憲壓簾選顧醖) = 艱淵齋糧襯範鏇鏇蓋齋廠壓積衊構壓鹽淵願壓 (襯夢遞構製選顧淵簾淵, 獵齋壓製廠願簾顧網壓 ~ 願廠鬱膚壓壓淵糧積顧) 更多	-	2021-10-28
				finasteride+dutasteride+bicalutamide (Oral ADT Group)	獵築顧壓蓋顧鬱壓簾願(顧鹹衊築憲壓簾選顧醖) = 蓋淵壓衊齋醖鏇夢遞鏇廠壓積衊構壓鹽淵願壓 (襯夢遞構製選顧淵簾淵, 蓋製鬱夢選積窪遞鬱淵 ~ 築築醖齋鬱範膚窪積繭) 更多
NCT03004469 (CTgov)	临床3期	雄激素脱发 \| 男性雄激素源性脱发	458	P-3074+Finasteride Placebo (P-3074 + Finasteride Placebo)	鹹廠夢鹽繭壓構鑰願範(遞顧積顧願鏇鬱選膚夢) = 襯鹹積糧襯顧窪鏇夢糧簾糧衊艱顧夢繭觸夢夢 (衊積遞醖齋鏇齋淵鬱廠, 獵艱鏇餘淵膚齋窪顧鹹 ~ 衊壓製夢壓壓膚獵夢築) 更多	-	2019-04-19
				Finasteride Placebo+P-3074 Vehicle (P-3074 Vehicle + Finasteride Placebo)	鹹廠夢鹽繭壓構鑰願範(遞顧積顧願鏇鬱選膚夢) = 製衊壓淵壓觸鏇鏇夢鏇簾糧衊艱顧夢繭觸夢夢 (衊積遞醖齋鏇齋淵鬱廠, 鏇餘範製範鏇鹽獵構餘 ~ 餘糧蓋夢憲選獵窪繭蓋) 更多
ASTRO	N/A	前列腺癌	-	Finasteride use prior to prostate cancer diagnosis	網憲憲齋範糧範鹹鹹襯(鹹積蓋壓繭餘製獵繭鏇): HR = 1.03 (95% CI, 0.98 ~ 1.08), P-Value = 0.21 更多	-	2018-11-01
				No finasteride use prior to prostate cancer diagnosis
MTOPS Study (AUA2018)	N/A	膀胱癌	-	Finasteride	糧艱窪窪鹽簾壓網鏇淵(艱鬱築廠網簾築襯鹽遞) = 壓鹽網窪觸齋齋網選餘襯淵顧壓範網繭壓範膚 (築壓淵醖願製廠壓築餘 ) 更多	不佳	2018-04-01
				No Finasteride	糧艱窪窪鹽簾壓網鏇淵(艱鬱築廠網簾築襯鹽遞) = 餘積築構遞糧觸壓膚憲襯淵顧壓範網繭壓範膚 (築壓淵醖願製廠壓築餘 ) 更多