The aim of this observational study is to compare postoperative analgesic consumption in patients who received peroperative carbetocin or oxytocin. The main question it aims to answer is:
. Does peroperative carbetocin use reduce postoperative analgesic consumption compared to oxytocin?
Patients who receive routine uterotonic agents in caesarean section surgeries will be divided into two groups and their postoperative 24-hour analgesic consumption will be compared.

开始日期2024-10-04

申办/合作机构

Ankara Bilkent City Hospital

TCTR20241030008 / CompletedN/AIIT

Comparing the effectiveness of Carbetocin and Oxytocin in preventing postpartum hemorrhage in preeclampsia

开始日期2024-10-01

申办/合作机构-

NCT06333340 / RecruitingN/AIIT

Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery: a Randomized Controlled Trial

The goal of this study is to compare 2 medications that are commonly used to prevent excess uterine bleeding (postpartum hemorrhage, or PPH) following cesarean delivery (CD), oxytocin and carbetocin. Most of the trials evaluating the preventative role of oxytocin and carbetocin after CD have focused on patient with low-risk of PPH.
This trial will focus on patients that are at increased risk of PPH, with risk factors such as: multiple gestation (twins, or more multiples), large baby, polyhydramnios (excess amniotic fluid), history of PPH, body mass index greater than 40, diabetes mellitus, hypertension, and placenta previa.
The investigators hypothesize that carbetocin would be more effective than an oxytocin regimen in reducing the risk of PPH in patients undergoing CD with any of the biological high-risk factors.

开始日期2024-10-01

申办/合作机构

Samuel Lunenfeld Research Institute

100 项与卡贝缩宫素相关的临床结果

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100 项与卡贝缩宫素相关的转化医学

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100 项与卡贝缩宫素相关的专利（医药）

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项与卡贝缩宫素相关的文献（医药）

2024-11-01·Journal of Obstetrics and Gynaecology Research

A randomized controlled trial on the comparison of two doses of carbetocin with oxytocin for the prevention of postpartum hemorrhage (concert trial)

Article

作者: Oladokun, Adesina ; Morhason‐Bello, Imran O. ; Bello, Yusuf O. ; Balogun, Rasheedat O. ; Lawal, Olatunji O. ; Odedele, Tolulope M.

AbstractAimTo compare the effectiveness of 50 and 100 μg of carbetocin with 10 IU of oxytocin for the prevention of postpartum hemorrhage (PPH).MethodsThis was a triple‐blind, non‐inferiority trial involving pregnant women recruited at term. We compared two doses of carbetocin (50 and 100 μg) with 10 IU of oxytocin administered as uterotonic agent after vaginal or cesarean delivery. Uterine contractility was assessed at 2‐ and 5‐min after uterotonic administration. The association between adequate uterine tone and PPH with the patients' characteristics were examined using the chi‐square test. Effect of the drugs on the odds of developing PPH was examined using logistics regressions. All analyses were conducted using STATA (StataCorp L.L.C.) with a significance level set at 0.05.ResultsIn total, 324 women (50 μg carbetocin group‐111, 100 μg carbetocin group‐106, and oxytocin group‐107) participated in the study. There was a significantly higher proportion of women with adequate uterine tone in those that had 100 μg carbetocin relative to 50 μg and 10 IU oxytocin at 5 min (p < 0.001). Patients who received oxytocin had a higher average blood loss than women that had either 50 or 100 μg carbetocin (p = 0.128). There was a significant difference in the need for additional uterotonic, with a higher proportion of participants among those who received 10 IU of oxytocin (p < 0.001).ConclusionPatients that had 100 μg of carbetocin had a better adequate uterine tone at the fifth minute compared to those who had 50 μg and 10 IU of oxytocin. Generally, carbetocin use was less likely associated with risk of PPH and use of additional intervention.

2024-09-01·European Journal of Obstetrics & Gynecology and Reproductive Biology

Carbetocin versus oxytocin for the prevention of postpartum haemorrhage during caesarean section in patients at high risk of bleeding

Article

作者: Cellier, Mathilde ; Vaunois, Agathe ; Raia-Barjat, Tiphaine ; Chauleur, Céline ; Delavallade, Mélanie ; Boukerfa-Bennacer, Yasmine

OBJECTIVETo evaluate the efficacy of carbetocin versus oxytocin in preventing postpartum haemorrhage (PPH) in women with risk factors for PPH who were delived by caesarean section.METHODSThis retrospective, monocentric, before-and-after cohort study assessed patients with haemorrhagic risk factors who underwent caesarean section after 24 weeks of gestation and who had haemorrhagic risk factors between August 2014 to December 2019.RESULTSThis study enrolled 518 patients, including 250 in the oxytocin group and 268 in the carbetocin group. The use of carbetocin was independently associated with a PPH decrease compared to oxytocin use (adjusted odds ratio [OR]: 0.52; 95 % confidence interval [CI]: 0.35-0.79; p = 0.002). Carbetocin use was associated with a reduction in the need for therapy escalation (6 % vs 10.8 %; p = 0.046).CONCLUSIONCarbetocin was more effective than oxytocin in preventing PPH after caesarean section in high-risk patients.

2024-09-01·Acta Obstetricia et Gynecologica Scandinavica

Intramyometrial and intravenous oxytocin compared to intravenous carbetocin for prevention of postpartum hemorrhage in elective cesarean section—A quasi‐randomized controlled phase IV non‐inferiority interventional trial

Article

作者: Haslinger, Christian ; Meier, Lea ; Kapfhammer, Elisabeth ; Ochsenbein-Kölble, Nicole ; Brun, Romana ; Zimmermann, Roland

AbstractIntroductionOur objective was to assess non‐inferiority of the unique approach used in our institution of combined 10 IU IM (intramyometrial) and 10 IU IV (intravenous) oxytocin to carbetocin IV in preventing severe postpartum blood loss in elective cesarean sections. The design was a prospective controlled phase IV non‐inferiority interventional trial. The setting was a tertiary center at University Hospital, Zurich, Switzerland.Material and MethodsThe population consisted of 550 women undergoing elective cesarean section after 36 completed weeks of gestation at low risk for postpartum hemorrhage (PPH). Participants were assigned to either combined oxytocin regimen (10 IU IM and 10 IU IV) or carbetocin (100 μg IV). Non‐inferiority for oxytocin for severe PPH was assessed with a 0.05 margin using the Newcombe–Wilson score method. The main outcome measures were severe postpartum blood loss defined as delta hemoglobin (∆Hb, Hb prepartum—Hb postpartum) ≥30 g/L.ResultsNon‐inferiority of combined oxytocin (IM/IV) in preventing severe postpartum blood loss was not shown (17 women in the oxytocin group vs. 7 in the carbetocin group). The number needed to treat when using carbetocin was 28. The risk difference for ∆Hb ≥30 g/L was 0.04 (oxytocin 0.06 vs. 0.03), 95% confidence interval (CI) (0.00–0.08). No significant difference was observed for ∆Hb (median 12 [IQR 7.0–19.0] vs. 11 [5.0–17.0], p = 0.07), estimated blood loss (median 500 [IQR 400–600] vs. 500 [400–575], p = 0.38), or the PPH rate defined as estimated blood loss ≥1000 mL (12[4.5] vs. 5 [2.0], risk difference 0.03, 95% CI (−0.01 to 0.06), p = 0.16). More additional uterotonics were administered in the oxytocin group compared to the carbetocin group (15.2% vs. 5.9%, p = 0.001). Total case costs were non‐significantly different in the oxytocin group (US $ 10 146 vs. 9621, mean difference 471.4, CI (−476.5 to 1419.3), p = 0.33).ConclusionsCombined (IM/IV) oxytocin is not non‐inferior to carbetocin regarding severe postpartum blood loss defined as postpartum Hb decrease ≥30 g/L in elective cesarean sections. We recommend carbetocin for use in clinical practice for elective cesarean sections.

项与卡贝缩宫素相关的新闻（医药）

2024-11-06

·Firstwordpharma

Acadia pockets $100M from paediatric voucher sale

After scoring the first FDA approval for a Rett syndrome treatment last year, Acadia Pharmaceuticals has now sold the rare paediatric disease priority review voucher it gained along with the greenlight. Daybue (trofinetide), an analogue of the neuropeptide IGF-1, was cleared to treat adult and paediatric patients two years and older with the rare genetic disorder.Acadia said the voucher sold for $150 million, but did not disclose the buyer. The drug developer will only profit $100 million off the sale, however, as Neuren Pharmaceuticals — from whom Acadia gained North American rights for Daybue — is entitled to one-third, or $50 million, of the proceeds. The funds will be invested into Acadia's commercial efforts, as well as its R&D work in central nervous system disorders and rare diseases.In addition to Daybue, the firm markets one other drug — Nuplazid (pimavanserin) for Parkinson’s disease psychosis.The company's pipeline features three clinical assets, and several undisclosed programmes in preclinical development. The most advanced, ACP-101, is in Phase III testing for hyperphagia in Prader-Willi syndrome. The next, ACP-204, is in Phase II testing for Alzheimer's disease psychosis, and Acadia has exclusive, worldwide rights to Phase I-stage candidate ACP-2591 for Rett and fragile X syndromes from Neuren. In March, Acadia's attempt to expand Nuplazid's label beyond psychosis and into schizophrenia crumbled after the inverse serotonin 5-HT2A receptor agonist failed a Phase III study.

临床3期临床2期优先审批上市批准

2024-10-27

·信狐药迅

罗欣药业替戈拉生第3个适应症根除幽门螺杆菌 | 新获批（10.21-10.27）

每周药品注册获批数据，分门别类呈现，一目了然。(10.21-10.27）新药上市申请药品名称企业注册分类受理号替戈拉生片山东罗欣药业集团股份有限公司2.4CXHS2300114替雷利珠单抗注射液勃林格殷格翰生物药业(中国)有限公司2.2CXSS2400013 新药临床申请药品名称企业注册分类受理号TQB3616胶囊正大天晴药业集团股份有限公司1CXHL2400823TQB3616胶囊正大天晴药业集团股份有限公司1CXHL2400822TQB3912片正大天晴药业集团股份有限公司1CXHL2400820注射用SM-V-61上海糖霁生物科技有限公司1CXHL2400766RBD1016注射液苏州瑞博生物技术股份有限公司1CXHL2400235BIOS2210杭州百诚医药科技股份有限公司2.2CXHL2400815BIOS2210杭州百诚医药科技股份有限公司2.2CXHL2400814贝派度酸片甘李药业山东有限公司3CYHL2400161冻干带状疱疹mRNA疫苗武汉瑞佶生物科技有限公司1.2CXSL2400514LVRNA007珠海丽凡达生物技术有限公司1.2CXSL2400512SCTV02注射液神州细胞工程有限公司1.2CXSL2400481四价流感病毒裂解疫苗(ZFA02佐剂)安徽智飞龙科马生物制药有限公司1.3CXSL2400485流感病毒亚单位疫苗(佐剂)江苏中慧元通生物科技股份有限公司1.4CXSL2400493三价流感病毒裂解疫苗(MDCK细胞)成都欧林生物科技股份有限公司2.2CXSL2400430注射用HS-20093上海翰森生物医药科技有限公司1CXSL2400543XKH001注射液浙江鑫康合生物医药科技有限公司1CXSL2400541注射用DB-1305映恩生物制药(苏州)有限公司1CXSL2400537PM8002注射液普米斯生物技术(珠海)有限公司1CXSL2400536注射用BGB-B3227广州百济神州生物制药有限公司1CXSL2400535HD004细胞华道(上海)生物医药有限公司1CXSL2400524SYS6020注射液石药集团中奇制药技术(石家庄)有限公司1CXSL2400511MSCohi-O镜片广东普罗凯融生物医药科技有限公司1CXSL2400496MSCohi-O镜片广东普罗凯融生物医药科技有限公司1CXSL2400495MSCohi-O镜片广东普罗凯融生物医药科技有限公司1CXSL2400494NK510细胞注射液上海贝斯昂科生物科技有限公司1CXSL2400492POV-601-1A1溶瘤病毒注射液苏州般若生物科技有限公司1CXSL2400482阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2400538 仿制药申请药品名称企业注册分类受理号注射用盐酸瑞芬太尼江苏恩华药业股份有限公司3CYHS2303613注射用盐酸瑞芬太尼江苏恩华药业股份有限公司3CYHS2303612盐酸丙美卡因滴眼液沈阳兴齐眼药股份有限公司3CYHS2303373氯硝西泮注射液江苏恩华药业股份有限公司3CYHS2301736盐酸美金刚口服溶液温岭市创新生物医药科技股份有限公司3CYHS2301351环丝氨酸胶囊石家庄四药有限公司3CYHS2301331己酮可可碱注射液华夏生生药业(北京)有限公司3CYHS2301197己酮可可碱注射液安徽美来药业股份有限公司3CYHS2301115注射用尼可地尔天大药业(云南)有限公司3CYHS2301036注射用尼可地尔天大药业(云南)有限公司3CYHS2301035己酮可可碱注射液南京卡文迪许生物工程技术有限公司3CYHS2300961磷酸奥司他韦干混悬剂华润三九医药股份有限公司3CYHS2300906琥珀酸美托洛尔缓释胶囊福建省宝诺医药研发有限公司3CYHS2300677生理氯化钠溶液辽宁民康制药有限公司3CYHS2300655生理氯化钠溶液辽宁民康制药有限公司3CYHS2300654注射用吲哚菁绿南京正大天晴制药有限公司3CYHS2300225克林霉素磷酸酯注射液国药集团国瑞药业有限公司3CYHS2300140克林霉素磷酸酯注射液国药集团国瑞药业有限公司3CYHS2300139乙酰半胱氨酸注射液四川汇宇制药股份有限公司3CYHS2201814国;CYHS2201814复方醋酸钠林格注射液仁合益康集团有限公司3CYHS2201740国;CYHS2201740复方醋酸钠林格注射液仁合益康集团有限公司3CYHS2201739国;CYHS2201739卡络磺钠注射液湖北欣泽霏药业有限公司3CYHS2200513国;CYHS2200513注射用头孢唑肟钠广东金城金素制药有限公司4CYHS2400225注射用头孢唑肟钠广东金城金素制药有限公司4CYHS2400224注射用头孢唑肟钠广东金城金素制药有限公司4CYHS2400223普拉洛芬滴眼液合肥利民制药有限公司4CYHS2302244间苯三酚注射液康普药业股份有限公司4CYHS2302141地诺孕素片湖南醇健制药科技有限公司4CYHS2301993艾曲泊帕乙醇胺片宏越科技(湖州)有限公司4CYHS2301969注射用氯诺昔康陕西丽彩药业有限公司4CYHS2301951复方聚乙二醇电解质散(III)成都利尔药业有限公司4CYHS2301884利培酮口腔崩解片兰西哈三联制药有限公司4CYHS2301879注射用头孢唑肟钠成都天之翼尚品医药科技有限公司4CYHS2301859注射用头孢唑肟钠成都天之翼尚品医药科技有限公司4CYHS2301858他达拉非片安徽贝克生物制药有限公司4CYHS2301709他达拉非片安徽贝克生物制药有限公司4CYHS2301708注射用阿糖胞苷四川上善六经医药科技有限公司4CYHS2301707注射用阿糖胞苷四川上善六经医药科技有限公司4CYHS2301706恩格列净片湖南汉森制药股份有限公司4CYHS2301626玻璃酸钠滴眼液吉林敖东药业集团延吉股份有限公司4CYHS2301526盐酸艾司洛尔氯化钠注射液北京百美特生物制药有限公司4CYHS2301401枸橼酸氢钾钠颗粒湖北午时医药研究院有限公司4CYHS2301399来曲唑片北京轩升制药有限公司4CYHS2301264克立硼罗软膏齐鲁制药有限公司4CYHS2301244克立硼罗软膏齐鲁制药有限公司4CYHS2301243精氨酸布洛芬颗粒南京卡文迪许生物工程技术有限公司4CYHS2301222精氨酸布洛芬颗粒南京卡文迪许生物工程技术有限公司4CYHS2301221精氨酸布洛芬颗粒南京卡文迪许生物工程技术有限公司4CYHS2301220盐酸羟考酮缓释片西南药业股份有限公司4CYHS2301181注射用氯诺昔康石家庄四药有限公司4CYHS2301147舒更葡糖钠注射液福建省宝诺医药研发有限公司4CYHS2301132吸入用复方异丙托溴铵溶液成都普什制药有限公司4CYHS2301122间苯三酚注射液四川诺非特生物药业科技有限公司4CYHS2300949注射用厄他培南重庆圣华曦药业股份有限公司4CYHS2300831盐酸乌拉地尔注射液江苏正大丰海制药有限公司4CYHS2300676玻璃酸钠滴眼液浙江尔婴药品有限公司4CYHS2300659玻璃酸钠滴眼液浙江尔婴药品有限公司4CYHS2300658依托咪酯中/长链脂肪乳注射液四川国瑞药业有限责任公司4CYHS2300636盐酸莫西沙星氯化钠注射液江苏睿实生物科技有限公司4CYHS2300575盐酸奥洛他定滴眼液湖北远大天天明制药有限公司4CYHS2300542盐酸奥洛他定滴眼液呋欧医药科技(湖州)有限公司4CYHS2300125卡贝缩宫素注射液成都通德药业有限公司4CYHS2300106普瑞巴林胶囊安徽九洲方圆制药有限公司4CYHS2202083国;CYHS2202083阿加曲班注射液浙江华海药业股份有限公司4CYHS2201603国;CYHS2201603b型流感嗜血杆菌结合疫苗罗益(无锡)生物制药有限公司3.3CXSS2400014托珠单抗注射液金宇博沃润泽生物技术有限公司3.3CXSS2300001 进口申请药品名称企业注册分类受理号尼拉帕利醋酸阿比特龙片Janssen-Cilag International NV2.3JXHS2300035尼拉帕利醋酸阿比特龙片Janssen-Cilag International NV2.3JXHS2300034多种油脂肪乳(C6-24)/氨基酸(16)/葡萄糖(42%)电解质注射液Fresenius Kabi AB5.1JXHS2200008国;JXHS2200008多种油脂肪乳(C6-24)/氨基酸(16)/葡萄糖(42%)电解质注射液Fresenius Kabi AB5.1JXHS2200010国;JXHS2200010多种油脂肪乳(C6-24)/氨基酸(16)/葡萄糖(42%)电解质注射液Fresenius Kabi AB5.1JXHS2200009国;JXHS2200009多种油脂肪乳(C6-24)/氨基酸(16)/葡萄糖(42%)电解质注射液Fresenius Kabi AB5.1JXHS2200011国;JXHS2200011阿卡波糖片STANDARD CHEM.& PHARM.CO.,LTD.5.2JYHS2200002国;JYHS2200002盐酸奎扎替尼片Daiichi Sankyo, Inc.2.4JXHL2400200盐酸奎扎替尼片Daiichi Sankyo, Inc.2.4JXHL2400199CID-103注射液CASI Pharmaceuticals, Inc.1JXSL2400148 中药相关申请无注：橙色字体部分结论为不批准或收到通知件；

疫苗临床申请临床1期CSCO会议申请上市

2024-09-04

·药精通Bio

多肽领域先行者，全产业链布局把握GLP-1历史机遇

成都圣诺生物科技股份有限公司成立于2001年7月，2021年A股上市（SH：688117）。圣诺生物从创立起就专注于多肽领域，具备多肽原料药和制剂的全流程研发管线和全产业链平台，能够为多肽创新药和仿制药提供从工艺路线设计，到小试、中试、工艺验证和质量研究等药学研究服务，以及药物研发及商业化生产所需原料药、制剂产品的全链条定制生产服务。 1. 深耕多肽领域二十余载，原料药+制剂+CDMO服务协同发展深耕多肽领域二十余载，圣诺生物是我国多肽药物领域的重要玩家。圣诺生物公司成立于2001年，于2021年在上交所上市，是国内成立较早的专业多肽药物生产企业之一。圣诺生物致力于为国内外医药企业的多肽类创新药研发提供药学研究和定制生产服务，自主研发、生产和销售多肽类仿制药原料药和制剂产品以及多肽药物生产技术转让服务。经过多年的研究与开发，公司在多肽药物研发和生产领域积累了先进的核心技术和丰富的研发生产经验，具有自主多肽合成和修饰核心技术，并积累了大量非专利技术，依托技术的不断创新，持续满足多肽医药市场需求。业务构成多元，原料药+制剂+CDMO服务协同发展。公司业务聚焦于多肽医药领域，主营产品和服务包括多肽原料药、多肽制剂、多肽创新药CDMO服务、受托加工服务以及多肽药物生产技术转让服务：多肽创新药CDMO服务：公司的药学研究服务针对客户筛选或指定的多肽分子进行药学研究，并将形成的研究资料和所生产样品交付客户用于进一步研发或注册申报，服务过程中的相关知识产权归客户所有。公司按照技术合同约定收取研发服务费用，相应费用计入主营业务成本。多肽原料药：公司已拥有19个自主研发的多肽类原料药品种。在国内市场，公司取得14个品种多肽原料药生产批件或激活备案，其中恩夫韦肽、卡贝缩宫素为国内首仿品种；在国外市场，公司比伐芦定、依替巴肽、利拉鲁肽等10个品种获得美国DMF备案，其中9个品种处于激活状态，可被制剂生产企业引用申报；艾替班特为首家提交此品种美国DMF备案的仿制原料药，并被我国卫健委纳入《第一批鼓励仿制药品目录建议清单》，比伐芦定国外客户成为美国第二家获批的仿制药制剂生产商。多肽制剂产品：公司多肽制剂立足于公司多肽原料药规模化生产能力，终端客户为国内医疗机构。公司多肽制剂产品均使用自产原料药生产，具有质量可靠、稳定性好等特点，已在全国31个省、自治区、直辖市销售。多肽类产品定制生产服务：多肽类产品定制生产服务包括为客户提供的定制肽生产服务，以及多肽原料药、制剂定制生产服务。定制肽生产服务包括为客户提供新药研发筛选阶段所需多肽化合物、对照品的定制生产，以及按照客户提供的产品结构定制生产的多肽化合物产品。多肽药物生产技术转让服务：公司多肽药物生产技术转让服务是指公司出于自身资本实力、药品审批风险、市场推广成本等因素考虑，将自主研发并已经向国家药品审批部门提交药品注册申请的多肽仿制药品种（包括原料药和制剂）的整体权益转让，包括但不限于知识产权及开发、商业化、销售和分销、再许可、对外许可和其他使用的权利、所有权和利益。受让方通常会与公司约定继续以公司名义申请生产批件，在获取相应的生产批件后，公司按照受让方指令组织相关产品的生产并收取相应的加工费用，相关产品销售及市场开拓由受让方负责。 2.多肽药物CDMO一站式服务，CDMO业务持续增长，技术优势助力CDMO发展多肽创新药CDMO服务是圣诺生物的主要业务构成之一，主要提供药学研究服务，针对客户筛选或指定的分子进行药学研究，并将形成的研究资料和所生产样品交付客户用于进一步研发或注册申报，符合中、美、欧申报要求，服务过程中的知识产权归客户所有。圣诺生物的多肽药物CDMO服务拥有国内完善的多肽药物研究平台，包括独立的原料小试生产车间、独立的原料中试生产车间、独立的制剂中试生产车间和相应独立的研究团队。且公司的研究团队专攻多肽领域多年，积累了宝贵的经验，致力于保质保速地完成产品申报，为创新药物抢占注册先机。公司在多肽药物研发生产领域获得较高的知名度和认可度，已先后完成50多个创新多肽药物的CMC研究，其中1个多肽创新药已获批上市进入商业化阶段，2个多肽创新药已申报生产，另有20余个多肽创新药进入临床试验阶段。 CDMO为公司业绩增长的潜力点。自2018年起，公司CDMO业务占主营业务收入比例不断上升，2023年占比达到24%。营收端，从2017年到2023年，公司CDMO收入从0.50亿元上升至1.03亿元，营收占比自2018年12%上升至2023年的24%。公司具有CDMO业务多项优势：多肽合成和修饰核心技术优势：公司自主研发并掌握了长链肽偶联技术、单硫环肽规模化生产技术等八项多肽合成和修饰类自主核心技术。质量稳定、收率高、规模化生产能力的业务优势：相比较于小分子CDMO，多肽创新药药学研究技术在生产过程中更加容易产生杂质过高、稳定性不达标等问题，更加考验服务企业的工艺研发和质量研究能力。从初始物料到原料药、制剂的研发生产一体化需求的成本优势：多肽药物生产一体化需求高，对服务方依赖性强。公司能够为多肽创新药和仿制药提供从工艺路线设计，到小试、中试、工艺验证和质量研究等药学研究服务，以及药物研发及商业化生产所需原料药、制剂产品的全链条定制生产服务。 3.强大的多肽生产能力圣诺生物多肽产业化能力位居全国前列，多肽原料药生产车间通过中国、美国、韩国和墨西哥的官方GMP认证，并实现了商业化生产，目前原料药生产线共计15条，仍有13条原料药生产线在建，预计2024年投产，投产后年生产多肽原料药可达1.5吨；多肽制剂生产车间涵盖了固体口服、外用制剂、黏膜给药、注射用产品等生产线，并有独立的高活生产线。 END 免责声明：本文仅作知识交流与分享及科普目的，不涉及商业宣传，不作为相关医疗指导或用药建议。文章如有侵权请联系删除。 IDC2024多肽与多条偶联药物研发与质控论坛圆满结束，点击图片查看会后报告，期待明年再聚~

核酸药物医药出海申请上市

100 项与卡贝缩宫素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D07229	卡贝缩宫素	H01BB03	DB01282

研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
出血	-	-	-

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
多食症	临床3期	加拿大	ACADIA Pharmaceuticals, Inc.	2023-11-27
多食症	临床3期	英国	ACADIA Pharmaceuticals, Inc.	2023-11-27
多食症	临床3期	美国	ACADIA Pharmaceuticals, Inc.	2023-11-27
普拉德-威利综合症	临床1期	澳大利亚	Levo Therapeutics, Inc.初创企业	2018-11-20
产后出血	临床1期	英国	Ferring Pharmaceuticals A/S	2015-02-01

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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


NCT03649477 (CARE-PWS, CTgov)	临床3期	普拉德-威利综合症	130	9.6 mg intranasal carbetocin (9.6 mg of LV-101)	遞遞窪醖簾淵積獵願積(糧構鬱鏇醖齋鏇襯壓構) = 鹽膚願範築糧觸衊觸衊膚網鏇衊顧鬱鏇觸憲艱 (願築鹹獵構糧夢蓋齋積, 窪廠遞構廠衊簾齋簾觸 ~ 製構鬱製遞遞築壓膚夢) 更多	-	2021-11-17
				3.2 mg intranasal carbetocin (3.2 mg of LV-101)	遞遞窪醖簾淵積獵願積(糧構鬱鏇醖齋鏇襯壓構) = 窪遞選餘顧選遞廠觸範膚網鏇衊顧鬱鏇觸憲艱 (願築鹹獵構糧夢蓋齋積, 鑰餘鹹簾願鏇顧醖餘鹹 ~ 齋積網製積網醖窪襯遞) 更多
NCT03716076 (CaRDIO, CTgov)	临床4期	窦性心律失常	50	Carbetocin (Participant Receives 50 mcg of Carbetocin Post-delivery.)	夢遞襯鹽夢壓糧觸餘鏇(選繭鹹壓願積積艱鏇網) = 淵獵蓋選鹽選鑰齋築積廠鬱築製範鹽壓鹹淵遞 (蓋衊積鏇衊構餘觸窪餘, 膚獵齋淵鏇淵遞網鏇鹹 ~ 齋醖鹽窪襯積窪選鑰製) 更多	-	2021-05-14
				Carbetocin (Participant Receives 100 mcg of Carbetocin Post-delivery.)	夢遞襯鹽夢壓糧觸餘鏇(選繭鹹壓願積積艱鏇網) = 簾網艱選鏇鹽衊鹽遞鬱廠鬱築製範鹽壓鹹淵遞 (蓋衊積鏇衊構餘觸窪餘, 鹽鑰夢願範鹹願鏇醖壓 ~ 廠餘網齋艱憲積觸窪製) 更多
NCT03649477 (CARE-PWS, BusinessWire) 人工标引	临床3期	普拉德-威利综合症	119	LV-101	醖壓築蓋鹹遞壓艱壓醖(窪蓋獵遞淵糧鑰膚衊繭) = not meet 蓋遞築選願鏇積壓糧網 (鹹構製築壓窪膚築鏇鏇 ) 更多	积极	2020-08-06
				Placebo
NCT03716076 (Pubmed \| Anesth Analg)	临床4期	-	50	Carbetocin 50 µg	(遞膚壓壓築繭遞選壓齋): milliseconds = 4.1 (95% CI, 0.8 ~ 7.5)	-	2020-03-05
				Carbetocin 100 µg
NCT03672045 (Pubmed)	N/A	肥胖	30	Carbetocin	鑰簾廠窪鑰願膚獵網艱(鑰鬱憲網夢顧範糧範觸) = 網遞網願網網餘製衊觸選鑰獵鬱艱艱築選鬱願 (鏇範觸網觸餘選製齋積, 621 ~ 1178) 更多	-	2020-03-01
NCT02079558 (IRCT, Pubmed \| J Matern Fetal Neonatal Med)	临床2期	产后出血	220	Carbetocin	廠簾蓋齋築餘壓鬱醖廠(廠鹽艱壓窪積積範鑰顧) = 糧鑰鏇顧獵積獵範鬱襯壓艱選憲鹹齋夢窪獵衊 (鹽憲獵積鏇淵顧積簾積 )	-	2018-11-01
				Oxytocin	廠簾蓋齋築餘壓鬱醖廠(廠鹽艱壓窪積積範鑰顧) = 餘廠餘積糧網遞襯鑰顧壓艱選憲鹹齋夢窪獵衊 (鹽憲獵積鏇淵顧積簾積 )
ACTRN12614000870651 (CHAMPION, Pubmed \| Br Dent J)	N/A	产后出血	-	Heat-stable carbetocin	(窪憲鹽觸遞壓廠鹹鏇淵) = 窪憲蓋鏇顧憲蓋壓鑰蓋齋遞壓願鑰蓋鹹衊鹹壓 (糧鑰醖淵鏇簾製淵遞鹽 )	-	2018-08-23
				Oxytocin	(窪憲鹽觸遞壓廠鹹鏇淵) = 醖夢齋獵鹽壓蓋衊範醖齋遞壓願鑰蓋鹹衊鹹壓 (糧鑰醖淵鏇簾製淵遞鹽 )
TCTR20160715004 (Pubmed \| Arch Gynecol Obstet)	N/A	怀孕	-	Intravenous carbetocin	襯齋範壓鑰網憲獵憲糧(鏇壓觸觸構簾築範襯築) = 艱顧獵選窪醖顧繭壓蓋醖衊鏇繭衊鑰糧選壓鏇 (鑰願憲顧艱遞願製蓋範 ) 更多	积极	2018-08-01
				Intravenous oxytocin	構膚獵範顧廠夢廠簾製(鑰鏇膚鏇觸積襯鏇廠觸) = 觸鹹餘獵艱鬱顧廠憲願範繭餘糧齋鹹觸艱齋顧 (鑰鏇壓範糧築鹹膚遞獵 ) 更多
NCT04482959 (Pubmed \| J Pept Sci)	临床4期	产后出血	40	Heat-stable carbetocin formulation	鑰壓選鏇衊壓鹹襯製窪(膚願鹹餘顧獵襯壓壓壓) = 觸製鑰顧鏇襯獵廠餘構選醖積蓋壓壓廠繭鏇鹽 (艱鹽構遞醖繭鏇糧鹽鏇 )	-	2018-06-01
Pubmed \| Eur J Obstet Gynecol Reprod Biol	N/A	-	-	Carbetocin	選糧廠範鏇遞簾憲廠繭(窪淵觸鬱蓋獵鹽鏇積鬱): RR = 0.68 (95% CI, 0.57 ~ 0.81), P-Value = <0.001	-	2016-03-01
				Oxytocin