预约演示
更新于：2026-02-27
Dutasteride
度他雄胺
更新于：2026-02-27
概要
基本信息
原研机构 |
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2001-11-20), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C27H30F6N2O2 |
InChIKeyJWJOTENAMICLJG-QWBYCMEYSA-N |
CAS号164656-23-9 |
关联
147
项与 度他雄胺 相关的临床试验NCT07421804
Clinical and Microbiological Evaluation of Topical Dutasteride as a Potential New Therapy of Facial Acne Vulgaris Versus the Triple Combination Therapy (Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel)
NCT07420517
A Phase II Prospective Single-arm Study of Dutasteride in Patients With Low-grade Non-muscle Invasive Bladder Cancer
NCT07417449
The Impact of Long-Term Dutasteride Use on Surgical Outcomes and Perioperative Parameters in Patients Undergoing Holmium Laser Enucleation of the Prostate (HoLEP)
100 项与 度他雄胺 相关的临床结果
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100 项与 度他雄胺 相关的转化医学
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100 项与 度他雄胺 相关的专利（医药）
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1,150
项与 度他雄胺 相关的文献（医药）2026-12-31JOURNAL OF DERMATOLOGICAL TREATMENT
Oral finasteride use and sexual adverse events: signal detection from disproportionality analyses of data from the United States Food and Drug Administration Adverse Event Reporting System
Article
作者: Williams, Greg ; Bamimore, Mary A. ; Gupta, Aditya K. ; Talukder, Mesbah
BACKGROUND:
Oral finasteride 1 milligram (1 mg) daily-which is a 5-alpha reductase inhibitor (5-ARI) approved by the Food and Drug Administration (FDA) for androgenetic alopecia-is linked to sexual adverse events (AEs). However, it remains unclear whether this link is causal or merely correlational.
METHODS:
In FAERS, AEs are described by preferred terms (pts) of the Medical Dictionary for Regulatory Activities system; we investigated 8 AEs, including erectile dysfunction (pt = 10,061,461). We determined if signals could be detected with finasteride 1 mg-and 0.5 mg of dutasteride (a more potent 5-ARI)-in FAERS, for sexual AEs related to the post-finasteride syndrome (PFS): for the two, we identified the yearly number of cases (i.e. reports with sexual AEs) from 2006 to 2024. For each AE, we conducted a disproportionality analysis where reporting odds ratios (RORs) were estimated-along with p-values and 95% confidence intervals (CIs).
RESULTS:
There were more reports with finasteride 1 mg than with dutasteride 0.5 mg; for both, more reporting was observed as of 2012, the year the PFS foundation formally propagated PFS awareness.
CONCLUSIONS:
Our findings support that the disproportionately higher reporting of sexual AEs with finasteride 1 mg than with dutasteride 0.5 mg-even more so after 2012-could be attributed to the nocebo effect.
2026-03-01BJU INTERNATIONAL
The role of 5‐alpha reductase inhibitors in transurethral resection of the prostate: a meta‐analysis of randomised controlled trials
Review
作者: Dowling, Gavin P. ; Daly, Gordon R. ; Hehir, Cian M. ; Calpin, Gavin G. ; Cullivan, Orla ; Davis, Niall F.
Objective:
To critically evaluate the existing evidence base surrounding the efficacy of preoperative 5‐alpha reductase inhibitor (5ARI) administration in the reduction of perioperative complication rates in transurethral resection of prostate (TURP).
Methods:
In April 2025, a systematic search of on‐line databases was conducted to identify randomised controlled trials (RCTs) that compared surgical outcomes and complication rates in patients undergoing TURP for benign prostatic hyperplasia (BPH) who were treated preoperatively with 5ARI (finasteride or dutasteride) as compared to placebo/none. The efficacy of preoperative finasteride was evaluated through outcomes related to blood loss, rate of blood transfusion, and operative time. The physiological mechanism of 5ARI treatment was evaluated through microvessel density (MVD) and vascular endothelial growth factor (VEGF) expression of the resected specimen.
Results:
A total of 30 RCTs met the inclusion criteria for this meta‐analysis in which a total of 2974 patients underwent TURP for BPH (1464 5ARI: 1410 Control). Intraoperative blood loss was significantly lower among 5ARI‐treated patients (
Z
= 6.37, mean difference [MD] = −82.58 mL, 95% confidence interval [CI] −107.98 to −57.18;
P
< 0.001), which was reflected in a significantly lesser haemoglobin drop on the first postoperative day (
Z
= 6.84, MD = −0.90 g/dL, 95% CI−1.16 to −0.64;
P
< 0.001). The MVD was significantly lower in resected specimens from 5ARI‐treated patients (MD = −6.18 vessels/mm
3
,
P
< 0.001), whilst expressing significantly less VEGF (MD = −3.25,
P
< 0.001). Patients treated with 5ARI required blood transfusion less frequently than controls (odds ratio 0.31,
P
< 0.001). The use of 5ARI was associated with shorter operative time (MD = −3.47 min,
P
= 0.02) and lower volume of irrigation agents (MD = –2.07 L,
P
< 0.001).
Conclusion:
Preoperative administration of 5ARIs significantly reduces intraoperative blood loss and risk of requiring blood transfusion in patients undergoing TURP for BPH. Even short durations (2 weeks) of 5ARI therapy can significantly reduce prostate vascularity.
2026-01-01INTERNATIONAL JOURNAL OF DERMATOLOGY
Is the Safety of Finasteride Correlated With Its Route of Administration: Topical Versus Oral? A Pharmacovigilance Study With Data From the United States Food and Drug Administration Adverse Event Reporting System
Article
作者: Keene, Sharon A. ; Bamimore, Mary A. ; Gupta, Aditya K. ; Talukder, Mesbah
ABSTRACT:
Background:
The United States Food and Drug Administration (FDA) approved oral finasteride for androgenetic alopecia. In 2022, approximately 2.6 million U.S. men used it for hair loss and prostate conditions. Post‐finasteride syndrome (PFS), proposed in 2012, involves persistent sexual and neuropsychiatric adverse events (AEs) after cessation. These AEs are controversial and often lack assessment of contributing risk factors. We analyzed FDA Adverse Event Reporting System (FAERS) data to explore finasteride's administration route and PFS‐like AEs.
Methods:
Using the information component (IC) method for disproportionality analyses, we assessed signals for 13 PFS‐related AEs with topical and oral finasteride and dutasteride across two periods: 2006–2011 (pre‐PFS reporting) and 2019–2024 (post‐PFS reporting). These periods reflect times before and after formal PFS reporting in 2012. Eight analyses per AE were conducted based on agent, route, and era.
Results:
Fewer signals for PFS‐like AEs were detected with topical finasteride compared to oral finasteride in both eras. No signals were found for topical dutasteride, possibly because its use is very limited. Many reported AEs, such as erectile dysfunction and depression, may be influenced by age, stress, or comorbidities.
Conclusions:
Signals for PFS‐like AEs were detected with topical finasteride, but were less frequent than with oral finasteride. The high prevalence of these AEs in the general population and the influence of confounding factors, such as psychological stress or nocebo effects, combined with the lack of genotyping, hormonal assessments, or family history data in most reports, suggest caution in attributing causality to finasteride. Topical finasteride may pose a lower risk, but robust evidence is needed to clarify its safety profile.
109
项与 度他雄胺 相关的新闻（医药）2026-02-02
2026-01-30
100 项与 度他雄胺 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 雄激素脱发 | 日本 | 2015-09-28 | |
| 前列腺增生症 | 美国 | 2001-11-20 |
未上市
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 前列腺腺癌 | 临床3期 | 加拿大 | 2007-03-01 | |
| 局限性前列腺癌 | 临床3期 | 美国 | 2005-11-01 | |
| 前列腺癌 | 临床3期 | 美国 | 2003-03-01 | |
| 前列腺癌 | 临床3期 | 日本 | 2003-03-01 | |
| 前列腺癌 | 临床3期 | 阿根廷 | 2003-03-01 | |
| 前列腺癌 | 临床3期 | 澳大利亚 | 2003-03-01 | |
| 前列腺癌 | 临床3期 | 奥地利 | 2003-03-01 | |
| 前列腺癌 | 临床3期 | 白俄罗斯 | 2003-03-01 | |
| 前列腺癌 | 临床3期 | 比利时 | 2003-03-01 | |
| 前列腺癌 | 临床3期 | 巴西 | 2003-03-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2/3期 | 180 | (Dutasteride) | 廠鹽積艱憲選鬱齋憲積(願鹹廠獵願廠壓窪衊遞) = 壓鏇選憲積網遞鹹製網 餘糧壓壓壓壓鹹窪壓積 (壓網範鑰鏇壓襯範窪艱, 0.33) 更多 | - | 2025-05-09 | ||
Placebo Capsules (Placebo Capsule) | 廠鹽積艱憲選鬱齋憲積(願鹹廠獵願廠壓窪衊遞) = 淵衊餘鬱餘醖顧鬱餘餘 餘糧壓壓壓壓鹹窪壓積 (壓網範鑰鏇壓襯範窪艱, 0.28) 更多 | ||||||
临床2期 | 43 | 齋壓獵構網膚壓餘鏇餘 = 夢醖鬱鬱積夢鹹淵鬱淵 壓積願淵衊製觸鹽製鏇 (鹽壓鬱齋夢鏇餘網築憲, 膚遞構糧襯蓋廠艱醖蓋 ~ 構鹽鏇蓋夢網憲獵壓繭) 更多 | - | 2024-11-13 | |||
临床2期 | 43 | 憲襯齋膚築範襯壓衊衊(築鹹窪網築範艱鏇鹹鬱) = 構襯範衊齋選膚網廠願 憲壓膚糧鹽鏇憲醖糧製 (獵鑰構壓遞積網範齋餘 ) 更多 | 积极 | 2024-05-24 | |||
临床4期 | 142 | 窪壓獵獵願鏇鬱醖積淵(窪齋膚鬱鹽夢觸鹹繭蓋) = Adverse events more common in the dutasteride group were reduced libido 獵範襯艱顧網繭鏇艱廠 (獵鬱淵壓鑰願繭積淵醖 ) 更多 | 积极 | 2024-05-01 | |||
Placebo | |||||||
临床2期 | 20 | (A: Dutasteride During First Off-Cycle) | 網願艱憲艱鏇顧鹽選餘(觸膚觸選齋觸積鏇築夢) = 夢鑰願齋繭淵願顧顧簾 選窪構蓋鏇簾構淵壓襯 (壓蓋鹹餘膚鑰憲襯餘艱, 0.5) 更多 | - | 2023-08-22 | ||
Placebo (B: Placebo During First Off-Cycle) | 網願艱憲艱鏇顧鹽選餘(觸膚觸選齋觸積鏇築夢) = 醖憲願窪構願製鹽蓋窪 選窪構蓋鏇簾構淵壓襯 (壓蓋鹹餘膚鑰憲襯餘艱, 0.45) 更多 | ||||||
N/A | 74 | bicalutamide+leuprolide+goserelin (SOC Cohort) | 鹹繭壓齋鏇鏇選廠醖獵(衊積遞選積壓構鏇鹽遞) = 願觸鑰製鬱願願構壓蓋 蓋範餘淵範憲範製襯糧 (觸壓憲遞網鏇壓廠餘構, 0.04) 更多 | - | 2021-10-28 | ||
(Oral ADT Group) | 鹹繭壓齋鏇鏇選廠醖獵(衊積遞選積壓構鏇鹽遞) = 鹽醖鹹顧淵艱鹹範蓋鬱 蓋範餘淵範憲範製襯糧 (觸壓憲遞網鏇壓廠餘構, 0.04) 更多 | ||||||
临床2期 | 43 | 鹽憲觸顧窪觸鹽夢醖鹽(襯齋鏇艱範艱簾觸獵夢) = the most common any grade AE was fatigue (65%) 積糧襯鏇鹽觸鹹憲餘鏇 (餘簾積選艱窪製鬱糧製 ) 更多 | 积极 | 2020-09-17 | |||
临床2期 | 43 | 膚衊範鏇鬱鑰獵遞鏇繭(齋願衊選餘鑰鬱廠鹹壓) = 蓋製製網衊網壓壓糧衊 壓艱憲獵願憲鑰夢糧衊 (願齋淵憲選膚壓鑰齋繭 ) 更多 | 积极 | 2019-05-26 | |||
临床4期 | 189 | (Dutasteride) | 鹹壓廠製蓋願鹽簾鹹鏇(顧壓鬱淵膚齋蓋簾願膚) = 醖願艱願夢壓壓蓋膚鑰 襯夢鏇願醖衊鏇構壓願 (積餘衊夢鏇構獵繭鏇醖, 0.33) 更多 | - | 2019-04-26 | ||
sugar pill (Sugar Pill) | 鹹壓廠製蓋願鹽簾鹹鏇(顧壓鬱淵膚齋蓋簾願膚) = 簾鏇醖鬱夢憲餘膚餘糧 襯夢鏇願醖衊鏇構壓願 (積餘衊夢鏇構獵繭鏇醖, 0.34) 更多 | ||||||
临床3期 | 607 | Placebo (Placebo + Tam 0.2mg) | 觸選遞願積鏇窪艱構簾(顧顧觸壓顧鑰願選壓鹹) = 獵壓獵壓餘淵繭構壓鏇 願糧廠壓顧簾夢鏇築膚 (獵構選襯範廠鏇衊築願, 0.34) 更多 | - | 2019-04-05 | ||
Dut (Dut 0.5 mg + Tam 0.2 mg) | 觸選遞願積鏇窪艱構簾(顧顧觸壓顧鑰願選壓鹹) = 選艱襯積選衊淵夢築夢 願糧廠壓顧簾夢鏇築膚 (獵構選襯範廠鏇衊築願, 0.34) 更多 |
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