A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TST002 Intervenous Injection in Postmenopausal Women and Men With Reduced Bone Mineral Density

This is a placebo-controlled, single-ascending dose, multicenter Phase I clinical study to evaluate the safety, tolerability, PK and PD characteristics of a single intravenous infusion of TST002 in subjects with reduced bone mineral density.

开始日期2022-04-28

申办/合作机构

杭州奕安济世生物药业有限公司初创企业

CTR20213044

/ Active, not recruiting临床1期

评估TST002注射液在骨密度降低受试者的安全性和耐受性及药代动力学的Ⅰ期临床研究

主要目的：评价TST002注射液的安全性和耐受性。次要目的：描述TST002注射液的药代动力学特征；评估TST002注射液的药效学特征；评价TST002注射液的免疫原性，评价其对PK和PD的可能影响；评价TST002的群体药代动力学，并评估TST002暴露量与药效学终点之间的关系。

开始日期2022-04-22

申办/合作机构

杭州奕安济世生物药业有限公司初创企业

NCT02337387

/ Terminated临床1期

A Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of 2 Formulations of Blosozumab in Postmenopausal Women

The purpose of this study is to evaluate the tolerability of two different formulations of blosozumab in women who have reached menopause.
This study will last approximately 12 weeks for each participant, not including screening. Screening is required within 28 days prior to starting the study.

开始日期2015-01-01

申办/合作机构

Eli Lilly & Co.

100 项与 Blosozumab 相关的临床结果

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100 项与 Blosozumab 相关的转化医学

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100 项与 Blosozumab 相关的专利（医药）

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项与 Blosozumab 相关的文献（医药）

2023-12-31·mAbs

Rapid in vitro assessment of the immunogenicity potential of engineered antibody therapeutics through detection of CD4 ⁺ T cell interleukin-2 secretion

Article

作者: Mishima, Masayuki ; Ikuno, Tatsuya ; Mizuno, Hideaki ; Takeiri, Akira ; Yano, Mariko ; Arata, Yoshiyuki ; Motoyama, Shigeki ; Nishito, Yukari ; Yabuki, Nami ; Tabo, Mitsuyasu ; Matsushita, Tomochika ; Kiyokawa, Jumpei ; Suzuki, Hiromi ; Ito, Shunsuke ; Chiba, Shuichi ; Honda, Masaki ; Kubo, Chiyomi ; Sampei, Zenjiro

Therapeutic antibodies sometimes elicit anti-drug antibodies (ADAs) that can affect efficacy and safety. Engineered antibodies that contain artificial amino acid sequences are potentially highly immunogenic, but this is currently difficult to predict. Therefore, it is important to efficiently assess immunogenicity during the development of complex antibody-based formats. Here, we present an in vitro peripheral blood mononuclear cell-based assay that can be used to assess immunogenicity potential within 3 days. This method involves examining the frequency and function of interleukin (IL)-2-secreting CD4⁺ T cells induced by therapeutic antibodies. IL-2-secreting CD4⁺ T cells seem to be functionally relevant to the immunogenic potential due to their proliferative activity and the expression of several cytokines. The rates of the donors responding to low and high immunogenic proteins, mAb1, and keyhole limpet hemocyanin were 1.3% and 93.5%, respectively. Seven antibodies with known rates of immunogenicity (etanercept, emicizumab, abciximab, romosozumab, blosozumab, humanized anti-human A33 antibody, and bococizumab) induced responses in 1.9%, 3.8%, 6.4%, 10.0%, 29.2%, 43.8%, and 89.5% of donors, respectively. These data are comparable with ADA incidences in clinical settings. Our results show that this assay can contribute to the swift assessment and mechanistic understanding of the immunogenicity of therapeutic antibodies.

2022-10-01·Annals of palliative medicine

Blosozumab in the treatment of postmenopausal women with osteoporosis: a systematic review and meta-analysis

Review

作者: Li, Hao ; Su, Yanlin ; Cai, Yuli ; Li, Nianhu ; Ma, Liang ; Liu, Fei ; Li, Gang ; Wang, Wenzhao

BACKGROUND:

Postmenopausal women are one of the most vulnerable groups to osteoporosis. Romosozumab is a newly monoclonal drug that inhibits the activity of sclerostin. Since it has been on the market for only 3 years, there is a lack of systematic analysis on postmenopausal women and the efficacy is not clear. In this study, we compared randomized controlled trials to assess the effects of blosozumab versus placebo in perimenopausal and postmenopausal women.

METHODS:

This meta-analysis has been registered in the PROSPERO registry (number CRD42020145839). The PubMed, Cochrane Library, ClinicalKey, and Embase databases were searched from inception date to July 01, 2021. We used the keywords "osteoporosis", "decreased bone mass", and "blosozumab" to retrieve studies on the relationship between blosozumab and osteoporosis in each database. The inclusion criteria were: (I) randomized controlled trials (RCTs) comparing the treatment of osteoporosis with blosozumab and a placebo or without treatment, (II) studies on postmenopausal women aged over 50 years, and (III) studies providing bone mineral density data. The quality of all randomized controlled trials included in this study was independently assessed by two researchers according to the Cochrane risk manual and was divided into high, medium and low quality. The main results analyzed were bone mineral density (BMD) and T-score. Our results mainly include BMD and procollagen type I N-terminal propeptide (P1NP), C-terminal telopeptide of type I collagen (CTX), bone-specific alkaline phosphatase (BSAP), and osteocalcin (OC).

RESULTS:

Three RCTs with 105 patients were selected from 157 retrieved articles. Due to high heterogeneity [BMD: Tau2=2.79; Chi2=11.70, degrees of freedom (df) =1 (P=0.0006); I2=91%], we could not perform statistical analysis of BMD. The results of BMD were then evaluated systematically. Three RCT studies were included in the evaluation. Compared with that of the placebo, blosozumab increased levels of the BMD biomarker osteocalcin [mean deviation (MD) 12.55; 95% confidence interval (CI), 8.18, 16.91; P<0.00001]. None of the 3 RCTs presented a risk of bias during the meta-analysis.

CONCLUSIONS:

The results suggested that blosozumab could be used as a target drug to improve BMD in postmenopausal women. This will provide a reference for the clinical treatment of postmenopausal women with osteoporosis.

2022-07-01·Journal of clinical densitometry : the official journal of the International Society for Clinical Densitometry4区 · 医学

Efficacy and safety of anti-sclerostin antibodies in the treatment of osteoporosis: A meta-analysis and systematic review

4区 · 医学

Review

作者: Raikos, Nikolaos ; Kouvelas, Dimitrios ; Poutoglidou, Frideriki ; Samoladas, Efthimios

Osteoporosis is a chronic disease with an increasing prevalence. Anti-sclerostin antibodies are being investigated for the treatment of osteoporosis. The aim of this systematic review and meta-analysis is to evaluate the efficacy and safety of antis-sclerostin antibodies compared to placebo and conventional therapies (alendronate and teriparatide) in the treatment of osteoporosis. Randomized controlled trials were searched from PubMed, EMBASE and Cochrane Central Register of Controlled Trails (CENTRAL) from their inception up to June 2021 by using Medical Subject Headings terms "anti-sclerostin antibody", "romosozumab", "blosozumab", "AMG 785″, "LY2541546", and "osteoporosis". Two investigators independently screened eligible studies, assessed the risk of bias and extracted the data from each study. The I² index was used to assess heterogeneity. Meta-analysis was conducted using the Review Manager Software (RevMan, Version 5.4). The GRADE approach was used to rate the quality of evidence for all the pooled outcomes. 8 RCTs with 12,416 patients met the inclusion criteria. Anti-sclerostin antibodies significantly increased lumbar spine, total hip and femoral neck bone mineral density compared to placebo, alendronate and teriparatide at both 6 and 12 mo. Adverse events were comparable between anti-sclerostin antibodies and other treatments, except for the incidence of injection-site reactions that was higher in the anti-sclerostin antibody groups. Anti-sclerostin antibodies represent a valid theurapeutic option in the treatment of osteoporosis. Further studies with longer duration and follow-up are needed to confirm the results of this meta-analysis.

项与 Blosozumab 相关的新闻（医药）

2024-08-29

·PRNewswire

Transcenta Holding Limited (Stock Code: 6628.HK) Announce 2024 Interim Results

2024 Interim Result Highlights (For the six months ended June 30, 2024 ) Company published the efficacy and safety data of Cohort-G of TranStar102 study for osemitamab (TST001), plus checkpoint inhibitor and CAPOX as the first-line treatment of patients with locally advanced or metastatic G/GEJ cancer at ASCO annual meeting, showing that high/medium Claudin18.2 expression is associated with a median PFS of 12.6 months. Company published the safety and PK data of TranStar101 study at the 2024 AACR annual meeting. The safety and pharmacokinetic profile of osemitamab (TST001) in the U.S. patients, is consistent with the profile reported in Chinese patients from TranStar102 study. Company continued the collaboration with Agilent Technologies, Inc. (Agilent), a world leader in CDx development, for Claudin18.2 specific IHC CDx Assay to support TranStar301 global Phase III pivotal trial of osemitamab (TST001) in combination with checkpoint inhibitor and chemotherapy. For Company's lead non-oncology asset, the anti-sclerostin antibody blosozumab (TST002), has been published Single Ascending Dose (SAD) study result in the 2024 World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO Congress) in April. After a single dose of blosozumab (TST002) up to 1,200 mg, the average increase of lumbar spine BMD at day 85 (D85) ranged from 3.52% to 6.20% and total hip BMD from 1.30% to 2.24% across dose cohorts. The lumbar spine BMD increase exceeded the least significant difference level (2.77%) and was clinically meaningful. Company has completed the enrolment of patients in the dose-escalation part for the First-in-Human (FIH) trial of the first-in-class anti-GREMLIN-1 antibody TST003 and the trial is ongoing at multiple clinical centers in the U.S. and China. Presented one Trial in Progress (TiP) poster of TST003-1001 study at the 2024 American Association for Cancer Research (AACR) annual meeting in April. HONG KONG, Aug. 29, 2024 /PRNewswire/ -- A clinical stage biopharmaceutical company – Transcenta Holding Limited ("Company"; stock code: 6628.HK) is pleased to announce the unaudited consolidated results of the Company and its subsidiaries (collectively, the "Group") for the six months ended June 30, 2024 (the "Reporting Period") In the first half of 2024, the Company continued to accelerate clinical progress across both the oncology and non-oncology pipelines. For company's lead oncology asset, the Claudin18.2-targeting antibody osemitamab (TST001, A Humanized ADCC Enhanced Claudin18.2 mAb for Solid Tumors), reached key milestones for the treatment of gastric or gastroesophageal junction (G/GEJ) cancer. Company published the encouraging Phase II data of osemitamab (TST001) in combination with checkpoint inhibitor and standard chemotherapy as first-line treatment of G/GEJ cancer at American Society of Clinical Oncology annual meeting (ASCO), showing that high/medium Claudin18.2 expression is associated with a median PFS of 12.6 months. At the same period, Company published the safety and PK data of TranStar101 study at the 2024 AACR annual meeting. The safety and pharmacokinetic profile of osemitamab (TST001) in the U.S. patients, is consistent with the profile reported in Chinese patients from TranStar102 study. Worked with Agilent Technologies, Inc. (Agilent), a world leader in CDx development, and developed a Claudin18.2 companion diagnostic test that can fully support the global pivotal trial of osemitamab (TST001). Successfully received regulatory clearances from the U.S. Food and Drug Administration (FDA), China Center for Drug Evaluation (CDE) and South Korea Ministry of Food and Drug Safety (MFDS). All the achievements validate and further support strategy for the Global Phase III trial (TranStar301). Osemitamab (TST001) is on track to become the first global therapy that delivers the next wave of innovation in the first-line treatment of patients with Claudin18.2 expressing locally advanced or metastatic G/GEJ cancer. Company also plans to explore several Claudin18.2 expressing advanced solid tumors other than G/GEJ cancer. For lead non-oncology asset, the anti-sclerostin antibody blosozumab (TST002, A Humanized Sclerostin mAb for Osteoporosis), published Single Ascending Dose (SAD) study result in the 2024 World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO Congress) in April. After a single dose of blosozumab (TST002) up to 1,200 mg, the average increase of lumbar spine BMD at day 85 (D85) ranged from 3.52% to 6.20% and total hip BMD from 1.30% to 2.24% across dose cohorts. The lumbar spine BMD increase exceeded the least significant difference level (2.77%) and was clinically meaningful. In addition, Company has completed the enrolment of patients in the dose-escalation part for the First-in-Human (FIH) trial of first-in-class anti-GREMLIN-1 antibody TST003 and the trial is ongoing at multiple clinical centers in the U.S. and China. Have presented one Trial in Progress (TiP) poster of TST003-1001 study at the 2024 American Association for Cancer Research (AACR) annual meeting in April. Furthermore, progress had been made in improving the continuous bioprocessing platform technology HiCB (Highly Intensified Continuous Bioprocessing) and the technology was successfully implemented in the GMP manufacturing of osemitamab (TST001). Research/Early Development Update: TST013 (An ADC Candidate Targeting a Validated Tumor Antigen)- TST013 displayed significantly improved anti-tumor activity relative to benchmark ADC and improved tolerability profile which warrants further development TST808 (A Humanized Antibody Neutralizing One of the Validated Key Targets Regulating B/Plasma Cell Proliferation and Survival) - TST808 has the potential to treat multiple autoimmune renal disorders including IgA nephropathy. Company has obtained the lead molecules and initiated the IND-enabling studies Business Development Achievements: Company has continued the collaboration with Agilent for the Claudin18.2 specific IHC CDx Assay to support TranStar301 global Phase III pivotal trial of osemitamab (TST001) in combination with checkpoint inhibitor and chemotherapy Company has continued the clinical trial collaboration with BMS, and completed the enrolment with osemitamab (TST001),checkpoint inhibitor and chemotherapy combination in TranStar102 in China and in TranStar101 in the U.S. Technology Partnership & Advancement: Company has formed a strategic alliance with a company specialized in siRNA drug substance synthesis, to provide CDMO services in siRNA formulation development and F&F Company's in-house cell culture media ExcelPro CHO are being evaluated for its performance against market standards for fed-batch, intensified fed-batch and perfusion processes by several external partners including a global leading company of media. This is part of potential collaboration for global commercialization of ExcelPro CHO About Transenta Holding Limited Transcenta is a clinical stage biopharmaceutical company with fully integrated capabilities in antibody-based biotherapeutics discovery, research, development and manufacturing. Transcenta has established global footprint, with Clinical Development Centers in Princeton, US, Beijing, Shanghai and Guangzhou in China, External Partnering Center in Boston and Los Angeles, US, Headquarters and Discovery, Clinical and Translational Research Center in Suzhou, Process and Product Development Center and Manufacturing Facility in Hangzhou. Transcenta has also initiated the construction of the Group Headquarters and the second high-end biopharmaceutical facility with ICB as its core technology in Suzhou Industrial Park. Transcenta is developing fourteen therapeutic antibody molecules for oncology and selected non-oncology indications including bone and kidney disorders. For more information, please browse the website of Transcenta Holding Limited: This Press release is published by Intelligent Joy Limited on behalf of Transcenta Holding Limited. SOURCE Transcenta Holding Limited

临床3期临床结果ASCO会议临床1期临床2期

2024-07-30

·echemi

The Hydroxyapatite Monoclonal Antibody Revolution: Romosozumab's Breakthrough and Challenges in Combating Osteoporosis with Emerging Therapies

Low density lipoprotein receptor-associated protein 5/6 (LRP5/6) forms a complex with Wnt protein that triggers cytoplasmic tail phosphorylation of LRP5 or LRP6, which in turn causes Axin to bind to it and inhibit the activity of glycogen synthase kinase (GSK-3β). This process leads to increased phosphorylation of β-catenin, promotes its nuclear translocation, forms complexes with DNA-binding proteins, activates target gene promoters, and ultimately promotes differentiation, proliferation, and survival of osteoblasts. Studies have revealed that Sclerostin secreted by Osteocytes (Osteocytes) interferes with Wnt signaling and stabilizes β-catenin by competitively binding LRP5/6, thus reducing osteogenic activity and triggering osteoporosis. Therefore, blocking the interaction between sclerotin and LRP5/6 can enhance Wnt signaling, increase bone formation, and inhibit bone resorption. By specifically binding to osteosin, osteosinomumab reduces its inhibition of Wnt signaling pathway, thereby promoting osteogenesis and inhibiting osteoclast, and realizing dual mechanism therapy for osteoporosis. Currently, only one drug that targets SOST, Romozolzumab, has been approved for marketing. Romosozumab is the first humanized IgG2 monoclonal antibody targeting SOST osteosclerosis protein, but its road to market has been challenging. In 2017, the FDA rejected romosozumab's U.S. marketing application, citing concerns about an increased risk of cardiovascular events in patients. Subsequently, Amgen and UCB provided additional Phase III clinical data at the FDA request, which was not approved until April 2023. However, the EU CHMP rejected romosozumab's marketing application in June of the same year due to cardiovascular risk concerns, which also limited its projected 2024 sales to only $3.2 billion. Setrusumab is the world's second SOST monoclonal antibody for the treatment of osteogenesis imperfecta (OI). OI is a rare genetic bone disorder characterized by low bone mass and fragility fractures. Setrusumab is a fully human IgG2 monoclonal antibody that treats OI by inhibiting the function of sclerosin, a protein that inhibits the activity of osteoblasts. In June, Ultragenyx Pharmaceutical and Mereo BioPharma announced that setrusumab showed significant results in a sustained reduction in fracture rates in Orbit, the Phase 2 portion of a 2/3 clinical trial for OI patients. Blosozumab is a humanized monoclonal antibody against osteosin developed by Eli Lilly for the treatment of osteoporosis. The company is licensed to develop and commercialize Blosozumab in Greater China. Lilly completed Phase II clinical trials in the United States and Japan, showing favorable safety and efficacy. In May 2023, Transom Group announced Phase I data showing that TST002 (Blosozumab) demonstrated a good safety and tolerability profile in all dose groups, and demonstrated a clinically significant increase in lumbar bone density in terms of efficacy. SHR-1222, China's first SOST monoclonal antibody developed by Hengrui Pharmaceutical, is currently in Phase I clinical trials. Osteoporosis is a systemic bone disease characterized by loss of bone mass and destruction of bone microstructure, resulting in increased bone fragility and susceptibility to fracture. With an aging population, China has the largest number of osteoporosis patients, with about 90 million patients, accounting for 7 percent of the total population, and at least 210 million people with lower than normal bone mass. Therefore, the market potential of osteoporosis treatment drugs is huge. The market size of osteoporosis drugs in China is expected to reach 36.8 billion yuan in 2025 and further grow to 51.2 billion yuan in 2030. The sclerotinomumab represented by Romozomumab provides a new strategy for the treatment of osteoporosis, which is expected to overcome the limitations of traditional drugs and become the focus of future research and treatment.

临床结果上市批准临床1期临床3期临床2期

2024-07-25

·CPHI制药在线

骨质疏松新机制药物罗莫佐单抗中国申报上市，百亿市场波澜再起

近日，中国国家药监局药品审评中心（CDE）官网公示，3.1类新药罗莫佐单抗注射液上市申请已获得受理，根据临床试验进展，推测此次申报的适应症为骨质疏松症。罗莫佐单抗是优时比和安进（Amgen）共同开发的骨硬化蛋白 (sclerostin)单克隆抗体，通过特异性抑制骨硬化蛋白，提高骨形成并降低骨吸收从而降低骨折风险。2019年1月，罗莫佐单抗首次在日本获批，用于治疗高骨折风险的骨质疏松症。2019年4月，罗莫佐单抗获得美国FDA批准，用于治疗具有高骨折风险的绝经后妇女的骨质疏松症。根据中国药物临床试验登记与信息公示官网，在中国，安进和优时比公司已经完成一项3期临床研究，该研究旨在中国绝经后骨质疏松症女性中评价罗莫佐单抗的疗效、安全性和耐受性。该研究实际入组总人数为327人。罗莫佐单抗的给药途径为皮下注射，每次两支（210mg），每月一次，共计给药12个月。 Wnt信号通路对骨骼发育和骨量调节都至关重要。正常情况下，Wnt蛋白与七跨膜受体（Frizzled）、低密度脂蛋白受体相关蛋白5/6（LRP5/6）结合，形成多聚体，从而导致LRP5或LRP6的细胞质尾部磷酸化，从而使蛋白Axin与之结合，抑制糖原合酶激酶（GSK-3β）的活性，进一步使得β-连环蛋白（β-catenin）水解增加，导致其核转位、与DNA结合蛋白结合，使得靶基因启动子激活，最终增加成骨细胞的分化、增殖和存活。研究发现，骨细胞（Osteocyte）分泌的硬骨素（Sclerostin），可以通过拮抗Wtn信号传导，竞争性的与LRP5或LRP6结合，通过稳定β-连环蛋白（β-catenin），减少信号传导，从而降低成骨活性，导致骨质疏松。因此，减少硬骨素（Sclerostin）与LRP5/6的结合，就可以增加Wnt信号的传导，从而增加骨形成，抑制骨吸收。硬骨素单抗能够与硬骨素靶向结合，从而减少硬骨素对Wnt信号通路的影响，从而增加成骨，抑制破骨，起到双重机制治疗骨质疏松。目前仅有罗莫佐单抗1个可作用于SOST靶点的药物获批上市。Romosozumab作为首款靶向SOST骨硬化蛋白的人源化IgG2单克隆抗体，其上市之路并非一帆风顺。2017年7月，FDA拒绝romosozumab在美国上市，此次拒绝批准上市申请主要是担心患者出现严重心脏或循环系统（例如心脏病发作或中风）的风险会增加。之后应FDA要求，Amgen和UCB补充了III期阳性药对照ARCH研究以及在男性骨质疏松患者中进行的BRIDGE研究的数据，延长了其审评期限，直到今年4月才获批上市。但今年6月欧盟CHMP拒绝了romosozumab的上市申请。此次，也是第二次被监管机构拒绝，同样是因为romosozumab在增加心血管风险方面的硬伤，也导致该药在2024年预计销售额仅有3.2亿美元。 Setrusumab全球第二款SOST单抗，用于治疗成骨不全症（OI）。OI是一种罕见的遗传性疾病，其特征是骨量低下、骨骼脆性增加和反复骨折，主要是由多种致病基因突变导致的。Setrusumab是一种靶向于硬化蛋白的全人源IgG2型单克隆抗体，可抑制硬化蛋白（抑制骨形成细胞活性的蛋白）的功能，用于成骨不全症的治疗。今年6月，Ultragenyx Pharmaceutical和Mereo BioPharma公司宣布，setrusumab在治疗成骨不全（OI）患者的2/3期临床试验Orbit的2期部分中，在至少14个月的随访中继续显著减少患者的骨折发生率。中位年化骨折发生率为0。 Blosozumab是由礼来研发用于治疗骨质疏松症的人源化抗硬骨素单克隆抗体候选药物。创胜集团于2019年获得礼来公司Blosozumab (TST002)在大中华区开发及商业化的授权。礼来已在美国和日本完成Blosozumab的II期临床研究并且获得了很好的安全性和疗效数据。2023年5月，创胜集团公布了I期揭盲数据，结果显示TST002 (Blosozumab)在所有剂量组中的整体安全性和耐受性良好。在疗效方面，所有200-1200mg剂量组在接受单剂量TST002 (Blosozumab)治疗后第85天均显示出具有临床意义的腰椎骨密度增加，与Blosozumab相似剂量水平的单剂量研究疗效相当。目前，创胜集团正在国内开展TST002 II期临床试验。 SHR-1222是唯一一款由国内企业恒瑞医药研发的SOST单抗，目前正在开展I期临床试验。骨质疏松症是一种以骨量低下，骨微结构破坏，导致骨脆性增加，易发生骨折为特征的全身性骨病。其与年龄相关性高，人口老龄化程度越高，患病人数越多。目前我国是骨质疏松患者数量最多的国家，骨质疏松患者人数约有9000万，约占总人口的7%，并且至少2.1亿人的骨量低于正常值。骨质疏松症是一种慢性病，我国在该领域的慢病患病人群基数大，且近年来患病率不断增加。因此，治疗骨质疏松症药物的市场空间非常可观。根据Frost&Sullivan，中国骨质疏松症药物市场规模从2017 年的194 亿元增长到2021年276 亿元，预计2021-2025、2025-2030年均复合增长率分别为8.54%、5.81%。以罗莫佐单抗为代表的硬骨素单抗成为骨质疏松症治疗的新机制药物，这种新型药物将克服经典药物的不足，成为骨质疏松治疗的未来方向，也是研究需要重点攻破的难点。参考来源 1. Lim S Y , Bolster M . Profile of romosozumab and its potential in the management of osteoporosis[J]. Drug Design Development and Therapy, 2017, 11:1221-1231. 2. Dove Medical Press. Shah AD, Shoback D, Lewiecki EM. Sclerostin inhibition: a novel therapeutic approach in the treatment of osteoporosis. Int J Womens Health.2015;7:565–580 内容来源于网络，如有侵权，请联系删除。

上市批准医药出海

100 项与 Blosozumab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10094	Blosozumab	-	DB12560

研发状态

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
骨质疏松症	临床2期	美国	Eli Lilly & Co.	2010-08-01
骨质疏松症	临床2期	日本	Eli Lilly & Co.	2010-08-01
骨质疏松症	临床2期	丹麦	Eli Lilly & Co.	2010-08-01
骨质疏松症	临床2期	爱沙尼亚	Eli Lilly & Co.	2010-08-01
骨质疏松症	临床2期	立陶宛	Eli Lilly & Co.	2010-08-01
绝经期后骨质疏松	临床1期	美国	Eli Lilly & Co.	2014-04-01

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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


PRNewswire 人工标引	临床1期	骨质疏松症	-	Blosozumab	鹽積衊淵蓋糧繭餘鏇餘(艱積膚範膚積廠鑰齋憲) = The average increase of lumbar spine BMD at Day 85 (D85) from baseline ranged from 3.52% to 6.20% across dose cohorts, all exceeding the least significant difference (2.77%). The increase of lumbar spine BMD in the placebo group was only 0.30% even with optimal calcium and vitamin D supplemental treatment. 鏇廠構範積淵鑰網壓鏇 (膚壓鹹襯廠襯鹹鹹窪壓 )	积极	2023-07-30
				placebo
NCT01742078 (CTgov)	临床1期	-	60	LY2541546 - IV (7.5 mg LY2541546 - IV)	窪襯選顧鏇夢觸築窪顧(遞築鏇鬱窪顧夢窪顧遞) = 選襯製窪衊簾夢淵窪遞網襯衊衊憲衊觸顧鏇蓋 (壓遞簾壓齋築壓鹹壓獵, 淵艱壓範蓋獵壓鹽憲鑰 ~ 糧鬱選繭齋襯鏇淵衊簾) 更多	-	2019-01-23
				LY2541546 - IV (25 mg LY2541546 - IV)	窪襯選顧鏇夢觸築窪顧(遞築鏇鬱窪顧夢窪顧遞) = 衊膚憲鬱糧艱繭餘廠壓網襯衊衊憲衊觸顧鏇蓋 (壓遞簾壓齋築壓鹹壓獵, 願糧淵淵簾顧鹽窪範鹽 ~ 壓築壓淵繭簾蓋鏇醖壓) 更多
NCT02337387 (CTgov)	临床1期	绝经期后骨质疏松	28	Blosozumab (Blosozumab Formulation A)	窪壓壓鏇齋製製鏇鬱衊(簾積顧淵醖顧壓構範獵) = 選醖餘蓋壓網鏇積遞醖餘醖遞願範鑰遞獵繭齋 (衊窪糧鹹糧簾壓醖窪壓, 襯網壓觸鏇網築鑰衊糧 ~ 淵衊顧鏇簾選壓鑰齋壓) 更多	-	2019-01-22
				Blosozumab (Blosozumab Formulation B)	窪壓壓鏇齋製製鏇鬱衊(簾積顧淵醖顧壓構範獵) = 齋鏇廠夢壓選簾齋積窪餘醖遞願範鑰遞獵繭齋 (衊窪糧鹹糧簾壓醖窪壓, 餘積齋衊壓選廠製艱糧 ~ 糧選夢築製鬱鏇窪憲積) 更多
NCT01742091 (CTgov)	临床1期	-	59	Placebo - SC+LY2541546 - SC (180 mg LY2541546 SC Q4W)	憲艱餘築構襯糧艱夢願(選簾廠壓簾夢簾膚衊艱) = 網築淵遞繭製醖築顧艱築築廠鹽憲衊鏇糧壓齋 (艱壓簾蓋觸窪鏇醖餘蓋, 壓顧製窪獵鏇襯簾鑰鬱 ~ 鬱蓋願選艱艱餘衊網鏇) 更多	-	2018-07-18
				LY2541546 - SC (270 mg LY2541546 SC Q2W)	憲艱餘築構襯糧艱夢願(選簾廠壓簾夢簾膚衊艱) = 蓋廠壓齋範鹽窪艱鬱艱築築廠鹽憲衊鏇糧壓齋 (艱壓簾蓋觸窪鏇醖餘蓋, 糧遞窪製艱選顧積構鏇 ~ 鏇艱築鹽膚簾鹹築淵夢) 更多
NCT02109042 (CTgov)	临床1期	绝经期后骨质疏松	15	Blosozumab (Weekly SC Blosozumab Injections)	窪膚糧鏇顧簾遞窪鹹獵(蓋鹽艱築醖夢襯壓鑰鏇) = 製艱鹹窪艱範衊網觸壓廠壓廠鬱鑰餘構淵鑰願 (願膚鏇鬱衊構襯獵淵選, 顧觸蓋積蓋衊憲鑰遞壓 ~ 憲鏇選願鏇廠蓋鑰艱範) 更多	-	2018-07-16
				Blosozumab (180 mg SC Blosozumab Injection)	鹹願獵製鬱遞艱夢繭鏇(廠壓鹹繭夢遞齋壓簾齋) = 構鑰觸鬱範遞淵艱夢顧選窪齋衊網鬱夢襯網窪 (製製廠糧鏇憲餘齋齋選, 齋構鬱壓廠夢遞製積範 ~ 糧膚選齋獵餘夢範獵積) 更多
NCT01144377 (CTgov)	临床2期	骨质疏松症	154	Placebo+LY2541546 (180 mg LY2541546 Q4W + Placebo)	網鑰鹽鬱構鹹廠壓觸構(構壓選齋願廠觸糧窪觸) = 構艱觸鬱憲願簾觸醖憲糧蓋選憲醖夢蓋獵糧衊 (壓窪選鹹鹹鑰夢獵構鑰, 蓋鹹淵觸簾簾鬱觸鹹遞 ~ 選鬱積鑰獵顧製鬱遞鏇) 更多	-	2017-12-04
				LY2541546 (180 mg LY2541546 Q2W)	網鑰鹽鬱構鹹廠壓觸構(構壓選齋願廠觸糧窪觸) = 鑰蓋鹹築選遞糧繭構衊糧蓋選憲醖夢蓋獵糧衊 (壓窪選鹹鹹鑰夢獵構鑰, 淵鹹憲糧鏇壓構鑰選糧 ~ 餘鬱憲蓋範鑰積憲衊網) 更多