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.

Start Date28 Apr 2022

Sponsor / Collaborator

Hangzhou Just Biotherapeutics Co. Ltd.Startup

CTR20213044

/ CompletedPhase 1

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

[Translation] A Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of TST002 injection in subjects with reduced bone density

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。

[Translation]

Primary objective: To evaluate the safety and tolerability of TST002 injection. Secondary objectives: To describe the pharmacokinetic characteristics of TST002 injection; To evaluate the pharmacodynamic characteristics of TST002 injection; To evaluate the immunogenicity of TST002 injection and its possible effects on PK and PD; To evaluate the population pharmacokinetics of TST002 and to evaluate the relationship between TST002 exposure and pharmacodynamic endpoints.

Start Date22 Apr 2022

Sponsor / Collaborator

Hangzhou Just Biotherapeutics Co. Ltd.Startup

NCT02337387

/ TerminatedPhase 1

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.

Start Date01 Jan 2015

Sponsor / Collaborator

Eli Lilly & Co.

100 Clinical Results associated with Blosozumab

100 Translational Medicine associated with Blosozumab

100 Patents (Medical) associated with Blosozumab

Literatures (Medical) associated with Blosozumab

31 Dec 2023·mAbs

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

Article

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

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.

01 Oct 2022·Annals of Palliative Medicine

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

Review

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

BACKGROUNDPostmenopausal 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.METHODSThis 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).RESULTSThree 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.CONCLUSIONSThe 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.

01 Jul 2022·Journal of Clinical DensitometryQ4 · MEDICINE

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

Q4 · MEDICINE

Review

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

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.

News (Medical) associated with Blosozumab

29 Aug 2024

·www.prnewswire.com

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

Phase 3Clinical ResultASCOPhase 1Phase 2

30 Jul 2024

·www.echemi.com

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.

Clinical ResultDrug ApprovalPhase 1Phase 3Phase 2

31 Jul 2023

·www.prnewswire.com

Transcenta Anti-sclerostin Monoclonal Antibody TST002 (Blosozumab) Received Approval from China CDE to Initiate Phase II Clinical Trial in Patients with Reduced Bone Mineral Density

SUZHOU, China, July 30, 2023 /PRNewswire/ -- Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that it has received approval from China Center for Drug Evaluation (CDE) to initiate Phase II clinical trial of TST002(Blosozumab). This study aims to evaluate the safety, tolerability, and pharmacokinetics of TST002(Blosozumab) after single and multiple intravenous administrations in patients with reduced bone mineral density. Osteoporosis is a significant health concern for the middle-aged and elderly population in China. It is estimated that by 2050, the number of osteoporosis patients will reach 120 million. Compared with RANKL mAbs, sclerostin mAbs successfully achieve the dual goal of preventing bone loss and rebuilding the bone. Evenity (Romosozumab) of Amgen is the only anti-sclerostin antibody drug that has been approved by the FDA in the United States. Up to the present, there was no anti-sclerostin antibody drug approved in China. In May 2023, Transcenta presented Phase I unblinded data, which showed that the overall safety and tolerability of TST002 (Blosozumab) in all dose cohorts is favorable. On the efficacy side, all dose cohorts from 200-1,200 mg have shown a clinically meaningful increase in lumbar spine BMD on Day 85 (D85) after a single dose of TST002 (Blosozumab) and comparable to those of Blosozumab single dose study at the similar dose levels. 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. In addition, encouraging BMD increase in total hip from 1.30% to 2.24% across dose cohorts were observed after single dose of TST002 (Blosozumab). In comparison, the mean percent change in lumbar spine BMD from baseline to month 12 was 5.4% after one year of Denosumab treatment.1 "We are excited to have received the clearance to move forward from CDE. Our Phase II will assess several regimens of TST002 (Blosozumab) with reduced dosing frequency, bringing us closer to our Phase III. We look forward to fully exploring the differentiated profile of TST002 to address the unmet medical need of the large patient population who suffers from osteoporosis," said Dr. Caroline Germa, Transcenta's Executive Vice President, Global Medicine Development and Chief Medical Officer. Reference: 1 About TST002 (Blosozumab) TST002 (Blosozumab) is a humanized anti-sclerostin monoclonal antibody as a drug candidate for osteoporosis and other bone loss diseases. It has a dual effect possessing both anabolic and anti-resorptive effects, which stimulates bone formation and inhibits bone absorption, resulting in fast increase in bone mineral density and bone strength. Blocking sclerostin activity in human treated with anti-sclerostin antibody or with naturally occurring genetic deletion has been shown to be an effective approach in increasing bone mineral density (BMD) and reducing bone fracture. Currently there is no approved anti-sclerostin antibody therapy in China yet although Romosozumab from Amgen has been approved in the United States, Europe and Japan. About Transcenta Holding Limited Transcenta (HKEX: 06628) 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 Headquarters and Discovery, Clinical and Translational Research Center in Suzhou, Process and Product Development Center and Manufacturing Facility in Hangzhou, and Clinical Development Centers in Princeton, US and in Beijing, Shanghai and Guangzhou of China, and External Partnering Center in Boston and Los Angeles, US. 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 13 therapeutic antibody molecules for oncology and selected non-oncology indications including bone and kidney disorders. For more information, please visit and . Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Transcenta, are intended to identify certain of such forward-looking statements. Transcenta does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Transcenta with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Transcenta's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Transcenta's competitive environment and political, economic, legal and social conditions. Transcenta, the Directors and the employees of Transcenta assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. SOURCE Transcenta Holding Limited

Phase 1Phase 2Clinical ResultDrug ApprovalPhase 3

100 Deals associated with Blosozumab

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KEGG	Wiki	ATC	Drug Bank
D10094	Blosozumab	-	DB12560

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Osteoporosis, Postmenopausal	Phase 2	United States	Eli Lilly & Co.	01 Apr 2014
Osteoporosis	Phase 2	Japan	Eli Lilly & Co.	01 Aug 2010
Osteoporosis	Phase 2	Estonia	Eli Lilly & Co.	01 Aug 2010
Osteoporosis	Phase 2	Lithuania	Eli Lilly & Co.	01 Aug 2010
Osteoporosis	Phase 2	Denmark	Eli Lilly & Co.	01 Aug 2010
Osteoporosis	Phase 2	United States	Eli Lilly & Co.	01 Aug 2010
Osteoporosis, Postmenopausal	Phase 1	United States	Eli Lilly & Co.	01 Apr 2014

Clinical Result

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Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01742078 (CTgov)	Phase 1	-	60	LY2541546 - IV (7.5 mg LY2541546 - IV)	wihnbvdecs(iyvuzwnmbn) = rjluzmumjo gbgulycxlu (ketlrxvhxs, cwnquouypy - jktzjanamw) View more	-	23 Jan 2019
				LY2541546 - IV (25 mg LY2541546 - IV)	wihnbvdecs(iyvuzwnmbn) = mxsxpazorf gbgulycxlu (ketlrxvhxs, hrihtpilgu - tagobbcxey) View more
NCT02337387 (CTgov)	Phase 1	Osteoporosis, Postmenopausal	28	Blosozumab (Blosozumab Formulation A)	jkrwibpuvg(uqldytroyf) = bvaapihrha ajgajdkgtd (gxtxqglmjy, jyzlybyyvl - muiexqxehk) View more	-	22 Jan 2019
				Blosozumab (Blosozumab Formulation B)	jkrwibpuvg(uqldytroyf) = wminidkvrt ajgajdkgtd (gxtxqglmjy, cupvjtrfbc - dayidofaor) View more
NCT01742091 (CTgov)	Phase 1	-	59	Placebo - SC+LY2541546 - SC (180 mg LY2541546 SC Q4W)	pciotjylon(opnhakgyim) = fhhrpkilxp txlmbtfrvl (blnjhiirlh, xidrbszfax - qctufhacss) View more	-	18 Jul 2018
				LY2541546 - SC (270 mg LY2541546 SC Q2W)	pciotjylon(opnhakgyim) = pchqazweza txlmbtfrvl (blnjhiirlh, mhrgdmlfjy - zhsjnvcdvg) View more
NCT02109042 (CTgov)	Phase 1	Osteoporosis, Postmenopausal	15	Blosozumab (Weekly SC Blosozumab Injections)	cmqrxmqfwm(lwzdheasit) = avybeyztto pmrphzcevx (rjeitjrotc, djttgixtqu - bfidpkognm) View more	-	16 Jul 2018
				Blosozumab (180 mg SC Blosozumab Injection)	gzkllgrayd(kvfxpcnnwc) = tdgwqrthmb mbgxpelgcl (sdesyxxzao, gpmrtbkpkg - vgnozweutn) View more
NCT01144377 (CTgov)	Phase 2	Osteoporosis	154	Placebo+LY2541546 (180 mg LY2541546 Q4W + Placebo)	gvtfcnxpdk(aixgxjpzal) = athqierhki qzqxeetash (cawxprxkjl, lntcjvxtto - dhnyavepnb) View more	-	04 Dec 2017
				LY2541546 (180 mg LY2541546 Q2W)	gvtfcnxpdk(aixgxjpzal) = hqhisvvtbf qzqxeetash (cawxprxkjl, osudgibccm - alqggbjrxq) View more

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