屈螺酮(Drospirenone) - 药物靶点：AR x MR x PR x Testosterone congeners_在研适应症：避孕_专利_临床

概要

基本信息

药物类型

小分子化药

别名

1,2-Dihydrospirorenone、6β,7β;15β,16β-Dimethylene-3-oxo-17α-pregn-4-ene-21,17-carbolactone、Dehydrospirorenone

+ [12]

靶点

AR x MR x PR x Testosterone congeners

作用机制

AR拮抗剂(雄激素受体拮抗剂)、MR拮抗剂(盐皮质激素受体拮抗剂)、PR激动剂(孕激素受体激动剂)

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

Hyundai Pharmaceutical Co., Ltd.

Exeltis USA, Inc.

Duchesnay, Inc.

非在研机构

Estetra SRLLaboratorios Leon Farma SA

最高研发阶段批准上市

首次获批日期

美国 (2019-05-23),

避孕

最高研发阶段(中国)-

特殊审评-

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结构

分子式C24H30O3

InChIKeyMETQSPRSQINEEU-HXCATZOESA-N

CAS号67392-87-4

关联

39

项与屈螺酮相关的临床试验

NCT06608186 / Not yet recruiting临床1/2期IIT

Can Drospirenone be Used to Prevent LH Surge in Controlled Ovarian Stimulation in PCOS Cases

The goal of this clinical trial is to learn if drospirenone can work to prevent LH surge in controlled ovarian stimulation in PCOS cases undergoing ART cycles. The main questions it aims to answer are:
Can drospirenone prevent LH surge in controlled ovarian stimulation in PCOS cases ? Can it prevent the occurance of ovarian hyperstimulation?
Researchers will compare drospirenone to cetrorelix (A well known drug for such cases) to see if drospirenone works the same way.
Participants will:
Take drospirenone or cetrorelix from stimulation day 5 ( 5 days of ovarian stimulation) till day of hCG trigger
- monitoring will be done before the cycle and through the cycles with vaginal ultrasound assessment and lab testing

开始日期2024-10-01

申办/合作机构

Benha University

NCT06345560 / Recruiting临床1/2期IIT

Pharmacokinetics of Drospirenone Only Pills in Obese Thai Women: A Pre- and Post-Bariatric Surgery Study

The purpose of this study is to investigate whether bariatric surgery affects Drospirenone only pills absorption

开始日期2024-04-18

申办/合作机构

University of Chulalongkorn

NCT06345586 / RecruitingN/AIIT

Drospirenone Only Pills and Cervical Mucus Changes in Obese Thai Women: A Pre- and Post-Bariatric Surgery Study

The purpose of this study is to study the effect of Drospirenone on cervical mucus change by modified Insler score, pre-bariatric surgery and post-bariatric surgery

开始日期2024-04-18

申办/合作机构

University of Chulalongkorn

100 项与屈螺酮相关的临床结果

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100 项与屈螺酮相关的转化医学

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100 项与屈螺酮相关的专利（医药）

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997

项与屈螺酮相关的文献（医药）

2024-12-31·GYNECOLOGICAL ENDOCRINOLOGY

The drospirenone only pill as a contraceptive option for breastfeeding women: First data on users’ acceptability and newborn development

Article

作者: Jakimiuk, Artur ; Regidor, Pedro Antonio ; Colli, Enrico

BACKGROUND:

Progestin-only pills (POPs) have been used for contraception in breastfeeding women for years. The existing guidelines allow the use of these contraceptives.

METHODS:

Multicenter study with a single visit and retrospective data review. The study involved 100 women who used a drospirenone-only pill (DRSP) for contraception for at least 5 months during breastfeeding. The study aimed to analyze for those successful users the impact on new-born development, the bleeding profile and evaluate user satisfaction.

RESULTS:

Analysis of the newborns showed that their growth parameters length and weight, were within the expected range of standard development. The mean birth weight was 3368 g, with the lowest recorded weight being 2860 g and the highest 5040 g. The median length of the newborns was 55 cm, ranging from 35 to 65 cm. All new-borns demonstrated appropriate growth within the established percentiles. Acceptability with the bleeding profile was rated with a VAS score: the mean acceptability rating was 82.8. Women aged 35 years or older reported significantly higher acceptability compared to younger women (≥35 years: mean = 88.4, SD = 16.5; <35 years: mean = 80.3, SD = 20.2) (p = 0.02). Sixty-one patients (N = 61; 61.0%; 95% CI: 50.7 - 70.4%) expressed willingness to continue using DRSP after breastfeeding.

CONCLUSION:

Among those patients who continued the use of the DRSP only-pill for 5 months, this study shows no negative impact for new-borns, with no clinical influence observed on their growth. Additionally, those users expressed high satisfaction with the bleeding profile of the pill.Clinical trial registration number: DRKS00028438 .

2024-12-01·SEXUALLY TRANSMITTED INFECTIONS

Drospirenone: a new progestogen-only contraception for future use in integrated sexual health services

Article

作者: Cannon, Rebecca ; Jewell, Suzanne

2024-11-01·FERTILITY AND STERILITY

Efficacy and safety of the combination of estetrol 15 mg/drospirenone 3 mg in a cyclic regimen for the treatment of endometriosis-associated pain and objective gynecological findings: a multicenter, placebo-controlled, double-blind, randomized study

Article

作者: Hirakawa, Akihiro ; Harada, Tasuku ; Takayanagi, Toshiaki ; Nogami, Masayoshi ; Hirayama, Masashi ; Osuga, Yutaka ; Kobayashi, Takao ; Mochiyama, Takayuki ; Foidart, Jean-Michel

OBJECTIVE:

To evaluate the efficacy and safety of 24-week cyclic administration of estetrol (E4) (15 mg)/drospirenone (DRSP) (3 mg) in Japanese patients with endometriosis.

DESIGN:

A 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study.

SETTING:

Twenty-five study centers in Japan.

PATIENT(S):

A total of 162 Japanese women diagnosed with endometriosis.

INTERVENTION(S):

Participants were randomly allocated to the E4/DRSP group or the placebo group. In the E4/DRSP group, participants were orally administered one tablet containing E4 (15 mg) and DRSP (3 mg) daily for 24 days, followed by one placebo tablet for 4 days for a hormone-free interval, constituting a 1-cycle regimen. One placebo tablet was administered once daily for 28 days to participants in the placebo group. The treatments were continued for six cycles (24 weeks) throughout the confirmatory period.

MAIN OUTCOME MEASURE(S):

Changes in visual analogue scale (VAS) scores for the most severe pelvic pain (lower abdominal and back pain) from baseline to six treatment cycles at the end of the confirmatory study period.

RESULT(S):

Estetrol/drospirenone showed changes in the mean VAS scores for the most severe pelvic pain (-33.2 mm) from baseline to the end of the 6-cycle treatment. The between-group difference was significant (-8.5 mm; 2-sided 95% confidence interval, -16.1 to -0.9 mm), showing superiority to placebo. The responder rates, ≥30% and ≥50% reductions in the VAS scores from baseline, were higher in the E4/DRSP group than in the placebo group: 53.2% vs. 29.6% and 36.4% vs. 12.3%. Objective gynecological findings (induration of the cul-de-sac, pelvic tenderness, and limited uterine mobility) were significantly improved by E4/DRSP treatment, and the proportions of stable and worsened participants were significantly lower than in the placebo group. Estetrol/drospirenone decreased the size of endometriomas and improved quality of life, on the basis of quality of life-related questionnaires and global impression scores. No safety concerns were observed with E4/DRSP treatment. Few differences were observed in the proportion of participants with hemostasis parameters outside the reference range between the E4/DRSP and placebo groups.

CONCLUSION(S):

Estetrol/drospirenone effectively treats endometriosis-associated pain and improves gynecological findings. Estetrol/drospirenone may be a safe, new option for endometriosis treatment with a potentially decreased risk of thromboembolic events.

CLINICAL TRIAL REGISTRATION NUMBER:

jRCT2011210027.

29

项与屈螺酮相关的新闻（医药）

2024-11-11

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2024-10-29

·凯莱英Asymchem

【行研】“生命之钥”——甾体药物

目前全球生产的甾体类药物已超过400种，是仅次于抗生素的第二大类药物，其中最主要的是甾体激素类药物，主要包括性激素、肾上腺皮质激素和其他类。根据溢多利2018年度报告统计显示，自二十世纪九十年代以来，国际市场甾体激素药物销售额每年以10%-15%的速度递增。目前，我国已经把甾体激素药物新资源开发作为医药行业近期发展的方向和重点之一，激素类原料药和中间体的出口也已成为我国原料药走向世界的重要品种。表1. 甾体药物分类来源：太平洋证券，凯莱英整理由于甾体药物产业链较长，根据甾体药物生产厂商的产品所处产业链的不同位置可以将产品分为起始物料、中间体、原料药及制剂。上游是起始物料以植物提取行业为主，从禾本科植物提取植物甾醇；产业链中游包括甾体药物原料加工(雄烯二酮、雄二烯二酮、9-羟基雄烯二酮等)、甾体药物原料药生产和甾体药物中间体生产；产业链下游是甾体药物制剂、销售渠道及终端患者。图1.甾体激素药产业链来源：根据公开资料整理甾体药物在维持生命、调解性功能、机体发育、免疫调解、皮肤疾病治疗及生育控制方面具有明确的作用，近年来市场规模持续增长。根据共研网数据，全球甾体药物市场规模由2011年的640亿美元增长至2021年的1475亿美元，年复合增速为8.71%。中国甾体药物市场规模由2011年的280亿美元增长至2021年的879亿美元，年复合增速为12.12%，2022年约为936亿美元，同比增长6.48%。中国甾体药物市场规模占全球的比重从2011年的44%增长至2021年的60%。下游甾体药物销售规模的增加趋势必然将提升中上游甾体药物原料、中间体及原料药企业市场销售规模。预计未来整个甾体药物行业将处于景气状态，其市场规模也将进一步扩大。图2.全球甾体药物市场规模（亿美元）来源：太平洋证券，凯莱英整理图3.中国甾体药物市场规模（亿美元）来源：太平洋证券，凯莱英整理甾体药物国际主要生产厂家为少数大型跨国制药公司，包括辉瑞、拜耳、默沙东、赛诺菲-安万特等。由于环保成本上升及我国具有原材料优势等多种因素，全球甾体药物生产出现了产业转移的趋势。近年来，由于我国原材料优势明显、生产工艺不断提升，已逐步成为世界甾体药物原料药生产中心。甾体原料药在全球消耗量持续增长，数据显示，2016-2021年全球皮质甾体激素类原料药消耗量呈现持续增长态势，至2021年达到387.58吨，CAGR为12.25%；性激素原料药消耗量增长快于皮质激素，2021年全球性激素原料药消耗量达到489.4吨，CAGR为45.05%。而目前我国甾体激素原料药年产量已占世界总产量的1/3左右，其中皮质激素原料药生产能力和实际产量均居世界第一位，2016年至今初皮质激素、性激素、孕激素和其他激素原料药的年均出口规模分别为 30000万美元、8000万美元、15000万美元。图4.全球皮质激素和性激素甾体原料药消耗量（吨）来源：华经产业研究院，凯莱英整理从具体品种来看，2021年全球皮质甾体激素类原料药消耗量387.58吨，相较于2016年增长率达12.25%。其中，泼尼松龙、氢化可的松、泼尼松全球原料药消耗量位列三甲，消耗量分别为111.49吨、71.25吨、51.60吨，市场占有率达60.5%；布地奈德、氟替卡松、糠酸氟替卡松为下游制剂全球销售额TOP3活性成分，2021年相应下游制剂全球销售额分别为96.84亿美元、82.83亿美元、78.61亿美元。 2021年全球性激素（甾体)原料药消耗量达到489.40吨，比2016年增长45.05%。其中，黄体酮、睾酮、甲地孕酮在全球原料药消耗量位列三甲，消耗量分别为330.37吨、32.36吨、27.27吨，市场份额总计79.69%；炔雌醇、雌二醇、屈螺酮为下游制剂全球销售额TOP3活性成分，2021年相应下游制剂全球销售额分别为30.04亿美元、17.83亿美元、17.48亿美元。图5.全球皮质甾体激素原料药年消耗量TOP10 来源：药招会，公开资料整理图6.全球性激素（甾体）原料药消耗量TOP10 来源：药招会，公开资料整理甾体药物下游制剂市场受疫情负面影响后又回暖。据统计，中国皮质甾体激素药品市场2016-2019年呈现持续增长态势，CAGR为34.61%，至2019年达到195亿元人民币，2020年受疫情影响，市场规模整体萎缩，2021年回暖至190亿元；性激素药物市场，2016-2019年呈现持续增长态势，CAGR为34.18%，至2019年达到84.21亿元人民币，2020年受疫情影响，市场规模整体萎缩，2021年回暖至96.61亿元。图7.国内皮质激素、性激素甾体制剂销售额（亿元）来源：根据公开资料整理总体来看，国内甾体制备技术的转型起步较晚，我国甾体药物相关产品生产厂商主要布局在中低档产品，国内可生产的高档产品品种较少。二十一世纪初受制于双烯价格居高不下，原料药厂商逐渐转向生物技术路线，相比传统工艺技术，生物技术路线具备成本低、污染少、产能高等三大优势，技术革新为国内甾体药物产业的良性发展提供了新动力。 References 参考文献 1.《聚焦甾体药物领域，产品向下游延展打开成长空间》，太平洋证券，2024.4 2.《原料药行业量升价稳，拐点将至》，开源证券，2024.4

2024-06-12

·Pharmaceutical Technology

Bankrupt Mithra cashes in on remaining assets for $188.2m

Mithra’s efforts to extend its cash runway earlier this year were unsuccessful. Image credit: Shutterstock/Nudphon Phuengsuwan. A day after filing for bankruptcy, Mithra has sold its share in two of its daughter pharmaceutical companies along with rights to its female hormone drug portfolio for €175m ($188.2m). Recommended Buyer's Guides Buyer's Guide Leading Guide to Packaging Materials, Containers and Containment Services for the Pharmaceutical Industry Buyer's Guide Leading Guide to Compliance Software for the Pharmaceutical Industry The deal saw Budapest-headquartered pharma company Gedeon Richter buy all of Mithra’s shares in Neuralis and Estetra – both subsidiaries of the struggling women’s health pharmaceutical company. Gedeon Richter also gained assets related to the manufacturing of estetrol. The funds, after deduction of financial debts, will be used to repay Mithra’s creditors, meaning the sale does not create any value for the shareholders of Mithra Pharmaceuticals , according to a 10 June press release. Belgium-based Mithra has faced severe financial difficulties in the past few years with share prices tanking by more than 90%. Efforts to extend its cash runway , which included raising $13.7m by selling its stake in Mayne Pharma , were unsuccessful, forcing the company to file for bankruptcy and siphon off its remaining holdings. The transfer will see Gedeon Richter gain rights to Mithra’s Estelle (estetrol-E4 / drospirenone), marketed as Nextstellis and Drovelis in the US and EU respectively. Estelle netted Mithra €2.6m in the first half of 2023. See Also: NPX-267 by NextPoint Therapeutics for Triple-Negative Breast Cancer (TNBC): Likelihood of Approval NPX-267 by NextPoint Therapeutics for Non-Small Cell Lung Cancer: Likelihood of Approval Gedeon Richter will also take on development duties for Mithra’s menopause treatment candidate Donesta which produced positive topline Phase III results in mid-2023. The orally administered estetrol (E4) hormone therapy is slated for US approval in 2024 and EU approval in 2025. Mithra said that “all 49 members of the personnel engaged by the transferred entities will be able to pursue their activities with Gedeon Richter,” along with 17 other employees who have been offered jobs by the latter company. Two of Mithra’s other properties – Novalon, a long-acting drug specialist entity it acquired in 2015, and a contract development and manufacturing organisation (CDMO) facility – remain unaffected by the deal with Gedeon Richter and stay under protection. Mithra said it expects offers to come in by mid-month subject to judicial protection measures being extended. In a statement released on 10 June announcing bankruptcy filing, Mithra stated its employees’ research and future progress “will outlive Mithra and will continue under a different banner from now on. We all hope that these efforts will lead to the development of new solutions that will benefit as many people as possible.”

临床3期并购临床结果

100 项与屈螺酮相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D03917	屈螺酮	G03AC10	DB01395

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避孕	美国	Exeltis USA, Inc.	2019-05-23

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子宫内膜异位症	临床3期	斯洛伐克	-	2021-07-24

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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


NCT04965116 (CTgov)	临床4期	母乳喂养 \| 避孕	30	Micronor+Slynd (Early Initiation d-POPs)	廠遞構夢夢觸繭鑰願壓(範襯範憲淵選製艱醖艱) = 鏇繭餘積淵簾艱構鑰廠築觸憲簾願壓鑰淵鑰鏇 (鏇襯選選衊製襯壓構蓋, 觸鏇鏇夢鬱積鬱鏇網膚 ~ 憲築願觸鹹築顧衊網遞) 更多	-	2024-04-19
				Micronor+Slynd (Early Initiation n-POPs)	廠遞構夢夢觸繭鑰願壓(範襯範憲淵選製艱醖艱) = 鹹範選鹽構範鹹鏇艱鹹築觸憲簾願壓鑰淵鑰鏇 (鏇襯選選衊製襯壓構蓋, 範壓廠鹽襯艱憲構築壓 ~ 夢觸繭廠窪餘範積遞簾) 更多
Pubmed \| Contraception	N/A	肥胖	-	drospirenone (Nonobese participants)	願願構製衊憲齋鑰範網(繭築築廠膚鹽鏇窪遞鹽) = 餘糧膚淵構鹽範簾齋鹽製選憲構簾網襯齋構觸 (夢壓壓範積顧願膚壓膚, 1.3 ~ 5.8)	积极	2023-12-01
				drospirenone (Obese participants)	願願構製衊憲齋鑰範網(繭築築廠膚鹽鏇窪遞鹽) = 鏇鏇衊積鏇窪襯範淵鑰製選憲構簾網襯齋構觸 (夢壓壓範積顧願膚壓膚, 0.8 ~ 7.3)
NCT02269241 (CTgov)	临床3期	避孕	1,552	LF111 (drospirenone)	醖積網襯廠鏇遞夢製築(壓築壓範構淵鹽蓋範鑰) = 鏇築襯憲蓋廠顧鑰鬱觸構廠夢鬱鏇膚衊範繭鑰 (淵齋窪繭範構窪醖襯鏇, 鹽襯衊範餘餘醖衊鹽窪 ~ 憲廠糧願積廠構壓簾窪) 更多	-	2019-07-23
NCT00633360 (CTgov)	N/A	抑郁症 \| 经前综合征	32	ethinyl estradiol+Drospirenone (Drospirenone and Ethinyl Estradiol)	鬱蓋築夢觸醖餘鏇餘齋(廠艱遞簾鑰觸網鬱繭衊) = 窪膚積顧積淵鬱醖廠憲網範簾鹹憲衊壓壓壓鹹 (糧壓鬱鹽艱憲鹹網製廠, 壓蓋簾積餘夢襯築鹽淵 ~ 廠製鏇簾淵夢鹽範醖簾) 更多	-	2017-03-20
				Placebo (Placebo)	鬱蓋築夢觸醖餘鏇餘齋(廠艱遞簾鑰觸網鬱繭衊) = 襯憲淵繭艱蓋衊觸窪鹹網範簾鹹憲衊壓壓壓鹹 (糧壓鬱鹽艱憲鹹網製廠, 鹽觸選鏇廠簾蓋蓋壓遞 ~ 積蓋醖壓憲獵觸簾顧獵) 更多
Pubmed \| Eur J Contracept Reprod Health Care	N/A	-	-	Drospirenone-only pill	壓夢憲糧鹹觸襯鬱築淵(憲構獵製齋淵夢製鬱鏇) = 鑰顧艱遞憲餘構衊簾鹽壓積窪範糧鬱餘鏇壓鬱 (鬱願淵衊簾齋壓艱廠鹽 ) 更多	积极	2015-11-02
				Desogestrel-only pill	壓夢憲糧鹹觸襯鬱築淵(憲構獵製齋淵夢製鬱鏇) = 夢鹹願築積製積繭蓋糧壓積窪範糧鬱餘鏇壓鬱 (鬱願淵衊簾齋壓艱廠鹽 ) 更多
NCT00442689 (CTgov)	N/A	代谢综合征 \| 多囊卵巢综合征	97	ethinyl estradiol+drospirenone (Oral Contraceptive - 1)	窪構願鹹構網醖廠壓顧(鹽繭鹽鹽選選糧廠選鬱) = 築鏇築獵鏇壓醖網鏇醖鏇憲憲醖鹽蓋鹹繭願簾 (獵窪製範獵網膚願襯憲, 願蓋簾構蓋艱鏇膚壓鹹 ~ 選獵製鬱製鬱窪鏇餘膚) 更多	-	2014-06-06
				Flutamide - 2 (Flutamide - 2)	窪構願鹹構網醖廠壓顧(鹽繭鹽鹽選選糧廠選鬱) = 鏇獵鹹積衊構範襯醖鏇鏇憲憲醖鹽蓋鹹繭願簾 (獵窪製範獵網膚願襯憲, 艱遞顧艱膚鏇觸夢鹹廠 ~ 選鬱膚構淵窪簾鏇憲夢) 更多
NCT00722800 (CTgov)	临床2期	化脓性汗腺炎	4	Ethinyl Estradiol (YAZ)+Drospirenone (Drospirenone and Ethinyl Estradiol (YAZ))	選積製積醖觸廠鹽蓋鏇(鹹淵願簾鹹鏇壓構顧範) = 願鏇餘衊窪夢鬱獵鏇夢衊鹹夢顧壓繭遞夢憲積 (餘遞築鏇憲醖夢蓋選艱, 壓選衊獵餘簾鹽襯鏇膚 ~ 糧淵鹹廠鹹餘艱簾簾選) 更多	-	2014-01-16
				Placebo (Placebo Tablets)	選積製積醖觸廠鹽蓋鏇(鹹淵願簾鹹鏇壓構顧範) = 艱構築壓願選鹹網醖膚衊鹹夢顧壓繭遞夢憲積 (餘遞築鏇憲醖夢蓋選艱, 壓選艱蓋蓋夢壓夢獵繭 ~ 鹹夢遞製選遞鏇築鏇製) 更多
NCT00722761 (CTgov)	临床3期	寻常痤疮	30	ethinyl estradiol+drospirenone (Drosperinone and Ethinyl Estradiol)	製衊願網繭積願築蓋鬱(窪齋選廠糧鬱糧壓齋網) = 網醖願廠網積顧鏇夢艱鏇鏇簾構繭鹽廠願蓋廠 (製醖夢積鹽範範築廠艱, 蓋夢壓範鑰齋艱夢糧築 ~ 膚鬱餘淵觸鹽製淵觸糧) 更多	-	2013-03-05
				Placebo tablet (Placebo Tablet)	製衊願網繭積願築蓋鬱(窪齋選廠糧鬱糧壓齋網) = 鏇廠窪鑰壓憲構廠醖築鏇鏇簾構繭鹽廠願蓋廠 (製醖夢積鹽範範築廠艱, 築夢襯齋壓獵製鑰醖蓋 ~ 襯膚糧簾鬱憲網窪廠齋) 更多