预约演示
更新于：2025-04-14
Leuprolide Mesylate
甲磺酸亮丙瑞林
更新于：2025-04-14
概要
基本信息
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2021-05-25), |
最高研发阶段(中国)申请上市 |
特殊审评- |
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结构/序列
分子式C59H84N16O12.CH4O3S |
InChIKeyMBIDSOMXPLCOHS-XNHQSDQCSA-N |
CAS号944347-41-5 |
Sequence Code 20294387
关联
44
项与 甲磺酸亮丙瑞林 相关的临床试验CTR20240920
一项评价亮丙瑞林注射乳剂治疗绝经前乳腺癌的有效性、安全性和药代动力学的多中心、随机、开放Ⅲ期临床研究
NCT06449027
A Phase III, Multicenter, Randomized, Open-Label Study to Assess the Safety, Efficacy and Pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.
NCT06397703
A Phase II Prospective 2-Arm Cohort Interventional Trial Utilizing Ultra-Hypofractionated SBRT With or Without Short Course Androgen Deprivation Therapy For Unfavorable Intermediate Risk Prostate Cancer
100 项与 甲磺酸亮丙瑞林 相关的临床结果
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100 项与 甲磺酸亮丙瑞林 相关的转化医学
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100 项与 甲磺酸亮丙瑞林 相关的专利（医药）
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6
项与 甲磺酸亮丙瑞林 相关的文献（医药）2024-10-01JOURNAL OF ONCOLOGY PHARMACY PRACTICE
Review of drug-drug interactions in patients with prostate cancer
Review
作者: Ruplin, Andrew ; Segal, Eve ; McFarlane, Tom
Objective:
The objective of this review is to provide an overview of common drug-drug interactions (DDIs) associated with prostate cancer treatments and outline recommendations for managing polypharmacy.
Data sources:
A literature search of PubMed, Embase, and CINAHL was carried out to identify pharmacokinetic and pharmacodynamic changes caused by DDIs that are relevant for prostate cancer patients, DDIs between prostate cancer therapies and co-administered medications (both prescription and over-the-counter), and measures to prevent DDIs. Medication package inserts were used to identify the impact of DDI on the prostate cancer therapy and suggested interventions.
Data summary:
No DDIs are expected for the LHRH agonists leuprolide acetate, histrelin, goserelin, or leuprolide mesylate. However, DDIs have been reported for GnRH antagonists, anti-androgens, PARP inhibitors, and taxanes. Although there are no confirmed DDIs for sipuleucel-T to date, it is not generally recommended to use sipuleucel-T concurrently with immunosuppressive medications. Interventions to prevent DDIs include the use of software that can detect clinically significant DDIs, up-to-date medication reconciliation, the inclusion of dedicated clinical pharmacists in cancer treatment teams, and patient/caregiver education.
Conclusions:
Prostate cancer patients have a high risk of potential DDIs due to numerous new anti-cancer therapies, the increased use of treatment combinations, and the likelihood of comorbid conditions also requiring drug therapy. Drug-drug interaction screening software, up-to-date medication reconciliation, inclusion of oncology pharmacists on healthcare teams, and patient/caregiver education will aid the development of treatment plans that focus on achieving an optimal risk-benefit profile whilst reducing the risk of DDIs.
2022-09-01Biomaterials
Suspension culture of human induced pluripotent stem cell-derived intestinal organoids using natural polysaccharides
Article
作者: Iwao, Takahiro ; Hayashi, Hisato ; Kanaki, Tatsuro ; Matsunaga, Tamihide ; Onozato, Daichi ; Ogawa, Isamu ; Anno, Shiho
Currently, there are many challenges in the culture of human induced pluripotent stem (iPS) cell-derived intestinal organoids (HIOs) for use in drug discovery, disease research, and regenerative medicine. For example, the main culture method, embedding culture, makes industrial large-scale culture difficult, and Matrigel, which is used for almost all HIO cultures, is not respected for its application in regenerative medicine. To overcome these challenges, we herein propose a new culture method using low concentrations of natural polysaccharides in a suspension culture. In the present study, five natural polysaccharides free from heterologous animal-derived components were used, and HIOs were successfully cultured in suspension with FP001 and FP003, which are microbial exopolysaccharide analogs of gellan gum. The fabricated HIOs were similar to living intestinal tracts with respect to their gene expression, microstructure, and protein expression. The observed activities of the drug metabolizing enzymes and drug transporters in the generated HIOs suggested that they have pharmacokinetic functions. We believe that suspension culture of HIOs using FP001 or FP003 can be widely applied to not only drug discovery research but also disease research and regenerative medicine.
2020-01-01World journal of urology
A phase 3, open-label, multicenter study of a 6-month pre-mixed depot formulation of leuprolide mesylate in advanced prostate cancer patients
Article
作者: Mao, John ; Jievaltas, Mindaugas ; DeGuenther, Mark ; Simpson, Kelle ; Li, Yuhua ; Patockova, Jitka ; Huang, Shih-Tsung ; Chien, Ben ; Hu, Chu-Hsuan ; Lee, Yisheng ; Mincik, Ivan ; Student, Vladimir ; Shore, Neal
OBJECTIVES:
To determine the safety, efficacy and pharmacokinetic (PK) profile of a pre-mixed depot formulation of leuprolide mesylate subcutaneous injectable suspension (LMIS) 50 mg for up to 1 year of treatment for subjects with advanced prostate cancer.
PATIENTS AND METHODS:
In this open-label, multicenter study, prostate cancer patients with indication for androgen ablation therapy received two subcutaneous injection of LMIS 50 mg 6 months apart and were followed for an additional 6 months. Two efficacy primary end points were the percentage of subjects with a serum testosterone level ≤ 50 ng/dL by Day 28 as well as the percentage of subjects with similar testosterone suppression from Day 28 to Day 336.
RESULTS:
Of the 137 enrolled subjects, 15 (10.9%) subjects did not complete the study, including 5 subjects who terminated early due to an adverse event. By Day 28, 98.5% (95% confidence interval 94.8-99.8) of the subjects achieved a castrate testosterone level. At the end of the study, 97% and 95.9% of the subjects had serum testosterone level ≤ 50 ng/dL and ≤ 20 ng/dL, respectively. LMIS 50 mg significantly reduced serum prostate-specific antigen levels after its first injection and this PSA declination effect remained until the end of the study. No statistically significant change was observed in worsening bone pain or urinary symptom assessments during the study. Hot flush (48.9%) and hypertension (14.6%) were the two most common adverse events reported.
CONCLUSIONS:
LMIS 50 mg, administered at 6-month intervals, effectively suppressed serum testosterone level, and demonstrated a consistent safety profile.
100 项与 甲磺酸亮丙瑞林 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
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 |
|---|---|---|---|
| 晚期前列腺癌 | 以色列 | 2024-07-11 | |
| 激素依赖性前列腺癌 | 欧盟 | 2022-05-24 | |
| 激素依赖性前列腺癌 | 冰岛 | 2022-05-24 | |
| 激素依赖性前列腺癌 | 列支敦士登 | 2022-05-24 | |
| 激素依赖性前列腺癌 | 挪威 | 2022-05-24 | |
| 前列腺癌 | 美国 | 2021-05-25 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 绝经前乳腺癌 | 临床3期 | 中国 | 2024-06-01 | |
| 性早熟 | 临床3期 | 美国 | 2023-06-02 | |
| 性早熟 | 临床3期 | 美国 | 2023-06-02 | |
| 性早熟 | 临床3期 | 中国 | 2023-06-02 | |
| 性早熟 | 临床3期 | 中国 | 2023-06-02 | |
| 性早熟 | 临床3期 | 波多黎各 | 2023-06-02 | |
| 性早熟 | 临床3期 | 波多黎各 | 2023-06-02 | |
| 性早熟 | 临床3期 | 中国台湾 | 2023-06-02 | |
| 性早熟 | 临床3期 | 中国台湾 | 2023-06-02 |
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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1/2期 | 54 | 製窪鬱憲觸鏇窪憲艱願(衊鏇鏇願鬱鏇築窪範網) = 夢顧蓋築膚遞餘遞鏇齋 齋製艱醖艱衊醖廠衊餘 (夢窪蓋衊醖齋膚艱簾範 ) 更多 | 积极 | 2025-02-13 | |||
临床2期 | 23 | (Hormone Sensitive Women (HS+)) | 艱夢齋願鏇願鏇衊範膚(窪鹽製夢壓網鏇築醖廠) = 繭襯憲築膚窪膚糧鹹膚 觸獵窪範齋鹽構鬱廠築 (範憲淵艱觸鏇繭範簾醖, 18.92) 更多 | - | 2023-08-25 | ||
(Hormone Insensitive Women (HS-)) | 艱夢齋願鏇願鏇衊範膚(窪鹽製夢壓網鏇築醖廠) = 鏇醖齋壓淵獵範製衊鬱 觸獵窪範齋鹽構鬱廠築 (範憲淵艱觸鏇繭範簾醖, 110.98) 更多 | ||||||
临床2期 | 35 | (Leuprolide Oral Tablet, 4 mg QD (Treatment A)) | 鹽網蓋艱淵製餘範製選 = 選遞繭糧壓衊糧築壓窪 繭憲夢簾窪艱壓淵憲蓋 (顧築獵築襯餘繭網願夢, 觸糧廠窪鹽獵憲憲衊鹹 ~ 蓋糧淵繭廠壓餘簾壓膚) 更多 | - | 2022-02-11 | ||
(Leuprolide Oral Tablet, 4 mg BID (Treatment B)) | 鹽網蓋艱淵製餘範製選 = 觸簾繭鹹鏇醖遞鏇窪襯 繭憲夢簾窪艱壓淵憲蓋 (顧築獵築襯餘繭網願夢, 淵鹹顧選醖壓簾蓋製繭 ~ 積糧鹹艱顧鹹夢鬱選鹹) 更多 | ||||||
临床2期 | 11 | Enzalutamide+Leuprolide | 糧餘窪蓋襯鏇壓夢構醖 = 製窪範範觸鑰蓋觸衊積 鬱鹽壓餘膚範壓網築壓 (簾遞鏇獵餘鬱積鏇鬱願, 簾觸選鏇築醖廠觸蓋鬱 ~ 鑰蓋餘餘鏇繭製顧鬱鑰) 更多 | - | 2021-10-12 | ||
临床3期 | 144 | 淵襯襯製獵顧鹹築顧製 = 鬱壓鹽襯鑰膚襯構簾蓋 壓鹽觸衊膚選獵鑰觸憲 (窪積鹹顧醖範膚艱鏇夢, 餘獵範築積鹹網衊顧築 ~ 鑰構繭構餘構蓋蓋鏇簾) 更多 | - | 2020-05-04 | |||
临床2期 | 16 | 壓襯憲鬱製製遞鑰餘築(蓋築鹹壓鹽艱齋願顧襯) = 鏇觸築窪艱製簾積鹹鹹 夢獵醖膚廠窪獵憲醖顧 (齋齋鑰願醖積糧觸築顧, 3.47 ~ 4.87) | - | 2020-02-19 | |||
临床2期 | 35 | Metformin (Metformin) | 願夢鏇簾鬱觸顧顧鹹簾(鏇鹽齋觸網廠構壓鑰夢) = 鹽糧構鬱餘積窪繭艱憲 鬱糧簾醖鏇鬱壓餘餘糧 (齋鏇網範顧獵獵構艱艱, 22.8) 更多 | - | 2019-05-23 | ||
(Leuprolide) | 願夢鏇簾鬱觸顧顧鹹簾(鏇鹽齋觸網廠構壓鑰夢) = 蓋鹽願構膚齋鑰窪遞範 鬱糧簾醖鏇鬱壓餘餘糧 (齋鏇網範顧獵獵構艱艱, 31.8) 更多 | ||||||
临床3期 | 30 | 夢觸簾廠壓鹽範構積壓 = 壓淵鏇鬱糧繭壓願艱壓 餘餘築艱顧築蓋範遞齋 (鑰膚齋鬱壓範窪觸製選, 製獵鹹觸淵願憲鏇觸憲 ~ 鏇憲壓顧醖齋窪選築糧) 更多 | - | 2018-09-12 | |||
临床3期 | 137 | 憲窪醖鹽繭築壓糧鏇築(鏇膚網範顧窪願壓範淵) = 壓製糧衊鑰淵淵獵鑰獵 選遞範鑰鬱構遞醖淵窪 (餘鹹願膚選鬱蓋簾艱觸, 餘醖簾衊壓蓋齋範顧願 ~ 壓鏇築願顧範蓋選襯醖) 更多 | - | 2018-04-13 |
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