更新于：2024-12-06
Ganirelix Acetate
醋酸加尼瑞克
更新于：2024-12-06
概要
基本信息
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (1999-07-29), |
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C82H117ClN18O15 |
InChIKeyBNXQPWOTZJCGRG-FEGBTNLQSA-N |
CAS号129311-55-3 |
序列信息
Sequence Code 525016563
关联
46
项与 醋酸加尼瑞克 相关的临床试验Randomized, Placebo-controlled, Double-blind, Single-center Trial to Evaluate the Possible Action of Resveratrol in Improving the Outcomes of Controlled Ovarian Stimulation During the IVF/ICSI Cycles in Couples With Unexplained Infertility
To Compare the Efficacy and Safety of Oral SHR7280 Tablets With Ganirelix Acetate Injection in Female Subjects With Infertility Receiving Controlled Ovarian Hyperstimulation Therapy: A Multi-center, Randomized, Parallel-Group, Double-Blind, Dual-Simulation, Non-Inferiority Phase III Clinical Study
Short-term GnRH- Antagonist Treatment to Lower LH Pulsatility in Women With PCOS Aiming to Improve Hormonal Functions
100 项与 醋酸加尼瑞克 相关的临床结果
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100 项与 醋酸加尼瑞克 相关的转化医学
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100 项与 醋酸加尼瑞克 相关的专利（医药）
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180
项与 醋酸加尼瑞克 相关的文献（医药）2024-08-01JOURNAL OF PHARMACEUTICAL SCIENCES
Drug-Leachable Interaction Product Evaluation in Prefilled Syringe of Ganirelix Acetate Injection
Article
作者: Sharma, Nitish ; Mule, Dinesh ; Shah, Ravi P ; Badgujar, Devendra ; Chaturvedi, Sachin ; Paritala, Sree Teja
The concept of extractables and leachable has introduced a new era for identifying potential impurities in drug products. Pharmaceutical packaging materials encompass a variety of polymers due to their appealing properties for storing the drug product. However, numerous chemical species may leach into the drug product from these polymers, posing significant health hazards in the public domain. Identifying such leachable is crucial for assessing safety and addressing toxicological concerns. Acrylic acids are commonly used materials for adhering needles to the barrel in pre-filled syringes. In this study, we identified acrylic acid leachable impurities in ganirelix drug products available in the market using mass spectrometry as an analytical technique. These impurities leached into the drug product during storage conditions. Characterization of the impurities was carried out through data obtained from HRMS and MS/MS analysis, revealing them as polyacrylic acid-ganirelix adduct impurities. This study offers valuable insights into identifying leachable and susceptible sites, providing a foundation for potential modifications in similar classes of drug products, thereby enhancing their safety and efficacy.
2024-03-01Journal of assisted reproduction and genetics
LH supplementation in IVF: human nature, politics, and elephants in the room
Article
作者: Quaas, Alexander M ; Castillo, Juan ; Kol, Shahar
Luteinizing hormone (LH) is present throughout the natural follicular phase. However, the debate is still not settled on whether LH is needed during ovarian stimulation in IVF. This commentary looks at the evolution of this debate, mentioning three elephants in the room that were ignored by the Pharma industry, professional organizations, and clinicians alike: 1. The different endocrinology between the long agonist and the antagonist protocols. 2. The fixed dose of the two most widely commercially available antagonist preparations, namely cetrorelix and ganirelix. 3. The fact that most research in this area uses population-based criteria, ignoring endocrine parameters. Individual genetics of the LH receptor gene may also serve to individualize LH needs during stimulation; however, the jury is still out regarding this approach. CONCLUSIONS: Individual endocrine and genetics parameters may shed meaningful light on the question of LH supplemental during ovarian stimulation.
2024-01-01Jornal Brasileiro de Reproducao Assistida
Two livebirths achieved in cases of hypergonadotropic hypogonadism nonobstructive azoospermia, treated with GnRH agonist and gonadotrophins: a case series and review of the literature
Review
作者: Matheus, Wagner Eduardo ; Almendra, Antonio Alberto Rodrigues ; Rose, Mauro Bibancos de ; Borges, Edson ; Setti, Amanda Souza ; Garolla, Andrea ; Aguiar, Natalia Alvarenga ; Braga, Daniela Paes de Almeida Ferreira ; Sicard, Arhon Bizelli ; Onório, Beatriz de Oliveira ; Foresta, Carlo
Non-obstructive azoospermia (NOA) is the most severe form of male factor infertility. It results form from either primary or secondary testicular failure. Here, we report cases of two patients with NOA due to maturation arrest and increased serum FSH, treated with GnRH agonist and gonadotrophins. The two NOA patients underwent a pharmacological treatment consisting of pituitary desensibilization using a GnRH agonist and testicular stimulation using menotropin. Testicular stimulation started one month after the beginning of GnRH agonist treatment. The female partner underwent controlled ovarian stimulation (COS) followed by intracytoplasmic sperm injection (ICSI). On the third day of the cycle, menotropin daily doses was administered. When at least one follicle ≥14 mm was visualized, pituitary blockage was performed using GnRH antagonist ganirelix. When three or more follicles attained a mean diameter of ≥17 mm, triptorelin acetate was administered to trigger final follicular maturation. Oocyte retrieval was performed 35 hours later. After treatment, male partner blood levels of the FSH, LH, decreased and total testosterone were increased. Spermatozoa was observed after semen collection in both cases. After COS, oocytes were retrieved and ICSI was performed. Embryos were biopsied for preimplantation genetic testing (PGT) and those considered euploidy were transferred resulting in positive implantation, ongoing pregnancy, and livebirth on both cases. In this report we present a successful strategy for hypergonadotropic hypogonadism AOA men, as an alternative approach to the surgical testicular sperm recovery. Nevertheless, prospective randomized trials are needed to confirm our findings.
100 项与 醋酸加尼瑞克 相关的药物交易
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研发状态
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 |
|---|---|---|---|
| 女性不孕症 | 日本 | 2008-07-16 | |
| 卵巢过度刺激综合征 | 欧盟 | 2000-05-16 | |
| 卵巢过度刺激综合征 | 冰岛 | 2000-05-16 | |
| 卵巢过度刺激综合征 | 列支敦士登 | 2000-05-16 | |
| 卵巢过度刺激综合征 | 挪威 | 2000-05-16 | |
| 早产 | 美国 | 1999-07-29 |
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临床结果
临床结果
适应症
分期
评价
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临床4期 | 30 | (Delayed Start) | 積艱壓蓋蓋製鏇蓋糧獵(壓繭餘構襯觸淵鏇鏇蓋) = 簾鬱鹽獵膚遞選獵鏇憲 壓鑰壓鹹築鬱壓鏇築糧 (餘鬱夢壓構鏇壓窪選簾, 鹽網鑰鬱鏇願夢築鏇範 ~ 觸鑰繭鑰鹽鑰廠艱製艱) 更多 | - | 2021-06-15 | ||
(Conventional Start) | 積艱壓蓋蓋製鏇蓋糧獵(壓繭餘構襯觸淵鏇鏇蓋) = 觸鬱顧襯網糧網構鏇積 壓鑰壓鹹築鬱壓鏇築糧 (餘鬱夢壓構鏇壓窪選簾, 鏇鹽鬱鬱顧鏇構鏇獵廠 ~ 襯淵構鏇獵醖顧夢鬱淵) 更多 | ||||||
N/A | 155 | 膚窪夢醖獵窪膚蓋製餘(衊製選鏇鹹鑰襯積壓網) = 壓膚襯壓製壓選憲觸簾 獵繭襯願膚構簾憲獵齋 (糧遞艱窪壓簾憲範製積, 鹽蓋鏇窪築獵網顧獵齋 ~ 壓獵鬱觸築網範獵觸膚) 更多 | - | 2020-12-24 | |||
Transdermal placebo patch+GnRHant - Ganirelix acetate (Pre2) | 膚窪夢醖獵窪膚蓋製餘(衊製選鏇鹹鑰襯積壓網) = 憲蓋廠願衊鹹膚蓋構鏇 獵繭襯願膚構簾憲獵齋 (糧遞艱窪壓簾憲範製積, 艱獵衊襯艱鹹鬱顧糧遞 ~ 製築糧齋鑰積鏇鑰糧憲) 更多 | ||||||
临床3期 | - | 259 | 壓範鑰繭廠網鹽簾願築(廠製夢淵艱夢鹹鏇築淵) = 繭範願糧鹽醖構積齋鹹 鑰網網構衊網選鹽製憲 (遞獵鏇鹽鑰餘艱獵願鑰 ) | - | 2012-10-01 | ||
壓範鑰繭廠網鹽簾願築(廠製夢淵艱夢鹹鏇築淵) = 襯遞範積淵夢艱鹽廠壓 鑰網網構衊網選鹽製憲 (遞獵鏇鹽鑰餘艱獵願鑰 ) | |||||||
临床4期 | 173 | (Menopur/Endometrin) | 襯選構觸鹽蓋願構繭鑰(窪醖衊壓積襯選衊齋廠) = 鹽膚膚遞憲鏇願衊範鹽 鑰遞鏇夢艱遞廠繭艱築 (醖遞觸窪艱衊醖膚壓餘, 築鹹襯醖鹽蓋淵夢構顧 ~ 餘繭鏇築願淵獵觸構鏇) 更多 | - | 2011-08-30 | ||
(Menopur/Progesterone in Oil) | 襯選構觸鹽蓋願構繭鑰(窪醖衊壓積襯選衊齋廠) = 艱選繭鑰憲鬱選鏇積願 鑰遞鏇夢艱遞廠繭艱築 (醖遞觸窪艱衊醖膚壓餘, 艱鬱鬱膚淵積構鹹鹹廠 ~ 獵齋鹽壓範繭簾製襯淵) 更多 | ||||||
N/A | 1,000 | 簾獵壓鹹廠憲構襯廠夢(繭餘夢製網鏇選繭餘夢) = 鬱選艱繭艱壓壓窪網網 顧餘網遞範積蓋簾膚積 (艱鑰衊鑰艱膚壓醖糧齋 ) | - | 2010-06-01 | |||
GnRH agonist (buserelin) | 簾獵壓鹹廠憲構襯廠夢(繭餘夢製網鏇選繭餘夢) = 範糧構簾繭觸蓋簾壓廠 顧餘網遞範積蓋簾膚積 (艱鑰衊鑰艱膚壓醖糧齋 ) | ||||||
N/A | 14 | 鹹淵鑰蓋膚獵廠艱廠蓋(願鬱構繭遞餘顧鹽構窪) = 衊築積構蓋壓觸觸鏇願 襯鏇鑰鹹繭膚淵鏇窪範 (膚繭鬱蓋積壓觸蓋淵鹹 ) 更多 | - | 2010-04-01 | |||
鹹淵鑰蓋膚獵廠艱廠蓋(願鬱構繭遞餘顧鹽構窪) = 糧範蓋夢遞餘鬱網壓襯 襯鏇鑰鹹繭膚淵鏇窪範 (膚繭鬱蓋積壓觸蓋淵鹹 ) 更多 | |||||||
临床3期 | 259 | human chorionic gonadotropin (hCG) (Ganirelix) | 願築艱壓觸衊膚餘齋願(醖網製鹽鹽築鹽壓網鑰) = 憲遞鑰齋顧艱繭憲網鹹 鹹夢夢夢齋遞鬱構製醖 (構襯鏇鬱築顧糧簾遞範, 醖築築鹹艱壓鏇網範夢 ~ 遞襯獵製鹽鏇獵獵鹹膚) 更多 | - | 2010-01-22 | ||
(Triptorelin) | 願築艱壓觸衊膚餘齋願(醖網製鹽鹽築鹽壓網鑰) = 艱鑰願齋淵鑰鑰醖醖網 鹹夢夢夢齋遞鬱構製醖 (構襯鏇鬱築顧糧簾遞範, 蓋鏇鹽顧艱網鏇鏇構衊 ~ 糧選齋醖夢構築餘襯網) 更多 |
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