This is a non-interventional registry of children treated with Norditropin® for short stature due to Noonan Syndrome (NS). This study aims to provide data on long-term growth evolution and safety of Norditropin® as well as Health Related Quality of Life (HRQoL) data. This registry will include the entirety of children treated with Norditropin® for short stature due to NS over the inclusion period. The decision to initiate treatment with commercially available Norditropin® is made by the patient/parents/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.

开始日期2022-03-16

申办/合作机构

Novo Nordisk A/S

NCT04042428

/ Completed临床1期IIT

Generation of Biological Samples Positive to Somatropin for Anti-doping Control

Background:
Somatropin, also known as recombinant growth hormone (rhGH), is one of the World Anti-Doping Agency (WADA) prohibited substances. Its consumption in athletes has been banned since 1990, as it is known to improve physical performance.
Hypothesis:
The subcutaneous administration of recombinant somatropin (rhGH) in healthy subjects allows obtaining positive doping samples.
The concentrations of hGH variants (isoforms) and biomarkers can be measured in serum.
Objectives:
Primary objective: To generate enough serum samples positive to recombinant somatropin in order to be analyzed as control samples by anti-doping laboratories.
Secondary objective: To determine the analytical parameters necessary to detect the administration of recombinant somatropin in healthy volunteers by direct and/or indirect methods.
Methods:
Phase I, open, randomized clinical trial, with a treatment condition (recombinant somatropin or rhGH) administered subcutaneously to 4 subjects (2:1 ratio). Control samples of the study correspond to basal samples of 2 subjects who do not receive any treatment.

开始日期2019-10-25

申办/合作机构

Consorci Mar Parc de Salut de Barcelona

NCT04121780

/ Recruiting临床2期IIT

Interventional Study of Growth Hormone Replacement Therapy in Retired Professional Football Players With Growth Hormone Deficiency

This is a randomized, double-blind, placebo-controlled, parallel-group trial with an open-label extension to evaluate the efficacy of growth hormone (GH) on cognitive functions of retired professional football players with growth hormone deficiency (GHD).

开始日期2019-10-08

申办/合作机构

Center for Neurological Studies

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114

项与重组人生长激素(Novo Nordisk A/S) 相关的文献（医药）

2025-03-03·Journal of the Endocrine Society

Adult Growth Hormone Deficiency (AGHD) and Outcomes (NordiNet and ANSWER)

Article

作者: Dichtel, Laura ; Carmichael, John D ; Kargi, Atil Y ; Weber, Matthias M ; Nedjatian, Navid ; Fridman, Moshe ; Kelepouris, Nicky

Abstract:

Adult growth hormone deficiency (AGHD) is a rare disease with both physiological and psychological effects for untreated patients. AGHD symptoms can improve over time with GH treatment. Here we have analyzed the long-term effectiveness and safety of short-acting GH replacement therapy (GHRT) in treatment naïve and nonnaïve patients with AGHD using real-world data from the NordiNet® International Outcome Study and American Norditropin® Studies: Web Enabled Research Program. Outcomes were compared between 3 age groups, comprised of patients aged 18 to 29 years, 30 to 39 years, and 40 to 59 years. The safety outcome was the incidence of nonserious and serious adverse reactions and serious adverse events by age group. Efficacy outcomes included mean GH exposure by age group alone, by sex and age group, or based on estrogen usage in female patients; IGF-I SD score (SDS) levels by sex and age group; mean glycated hemoglobin by sex and age group; and mean non-high-density lipoprotein cholesterol by sex and age group. The incidence rates of adverse events and reactions did not statistically differ between the 3 groups. Mean IGF-I SDS levels reached a normal range (−2 to 2) in ≥80% of patients from all groups in the effectiveness analysis set by year 2. Together with previous reports of older patients, these results support the real-world safety and efficacy of short-acting GHRT among all ages of patients with AGHD.

2025-01-02·Expert Opinion On Drug Safety

Evaluation of the safety and efficacy of biosimilar recombinant growth hormone in children with growth hormone deficiency: non-inferiority, randomized, parallel, multicentric and Phase III trial

Article

作者: Ghergherehchi, Robabeh ; Moravej, Hossein ; Amini, Hossein ; Khademolreza, Nasrin ; Akhlaghi, Aliasghar ; Ghaznavi, Sina ; Zaeri, Hossein ; Maleki, Elham ; Dalili, Setila ; Kharazmi, Hosseinali ; Shahbazi, Majid ; Servatian, Nazli ; Soheilipour, Fahimeh ; Taghavi, Behnam ; Hashemipour, Mahin ; Ghasemi, Mahmoud ; Arefnia, Serajaddin ; Didban, Abdollah ; Noorian, Shahab ; Omidvar, Shahriar ; Eshraghi, Peyman

OBJECTIVES:

This study is designed in order to compare the efficacy and safety of recombinant human growth hormone (rhGH) with the reference brand.

METHODS:

According to the inclusion criteria, 85 people in 13 Iranian centers were randomly selected to receive biosimilar Somatropin (Somatin®) (44 people) and reference Somatropin (Norditropin®) (41 people) at a dose of 35 µg/kg/d, seven days/week for 12 months. The primary outcomes included height velocity (HV) was measured during 12 months of treatment.

RESULTS:

The two intervention groups' Height changes were similar. The mean HV was 10.96 cm/year in the biosimilar group and 10.05 cm/year in the reference groups after 12 months. Estimates of the lower bounds of 95% CI for mean height differences in the biosimilar intervention group compared to the reference intervention group did not exceed the 2 cm margin. Therefore, the non-inferiority of biosimilar intervention compared to the brand product is verified. Common ADRs in both groups were nausea in two patients (2.4%), diarrhea in two patients (2.4%), increased body temperature in one patient (1.2%), and headache in one patient (1.2%).

CONCLUSIONS:

The finding of this study indicated that Somatin® and Norditropin® have comparable efficacy and safety profiles.

CLINICAL TRIAL REGISTRATION:

www.IRCT.irIRCT20171122037571N1.

2023-05-05·Journal of the Endocrine Society

Long-term Effectiveness and Safety of GH Replacement Therapy in Adults ≥60 Years: Data From NordiNet® IOS and ANSWER

Article

作者: Olsen, Anne Helene ; Weber, Matthias M ; Nedjatian, Navid ; Gordon, Murray B ; Höybye, Charlotte ; Kelepouris, Nicky ; Biller, Beverly M K ; Ferran, Jean-Marc

Abstract:

Context:

Effectiveness and safety data on GH replacement therapy (GHRT) in older adults with adult GH deficiency (AGHD) are limited.

Objective:

To compare GHRT safety and clinical outcomes in older (≥60 years and, for some outcomes, ≥75 years) and middle-aged (35–<60 years) patients with AGHD.

Design/setting:

Ten-year follow-up, real-world data from 2 large noninterventional studies—NordiNet® International Outcome Study (IOS) and the American Norditropin® Studies: Web-Enabled Research (ANSWER) Program—were analyzed.

Patients:

GH-naïve and non-naïve patients with AGHD.

Intervention:

Norditropin® (somatropin).

Main outcome measures:

Outcomes included GH exposure, IGF-I standard deviation scores (SDS), body mass index (BMI), glycated hemoglobin (HbA1c), serious and nonserious adverse reactions (SARs and NSARs, respectively), and serious adverse events (SAEs). Adverse reactions were events with possible/probable causal relationship to GHRT.

Results:

The effectiveness analysis set comprised 545 middle-aged and 214 older patients (19 aged ≥75 years) from NordiNet® IOS. The full analysis set comprised 1696 middle-aged and 652 older patients (59 aged ≥75 years) from both studies. Mean GH doses were higher in middle-aged vs older patients. For both age groups and sexes, mean IGF-I SDS increased following GHRT, while BMI and HbA1c changes were similar and small.Incidence rate ratios (IRRs) did not differ statistically between older and middle-aged patients for NSARs [IRR (mean, 95% confidence interval) 1.05 (.60; 1.83)] or SARs [.40 (.12; 1.32)]. SAEs were more frequent in older than middle-aged patients [IRR 1.84 (1.29; 2.62)].

Conclusion:

Clinical outcomes of GHRT in AGHD were similar in middle-aged and older patients, with no significantly increased risk of GHRT-related adverse reactions in older patients.

项与重组人生长激素(Novo Nordisk A/S) 相关的新闻（医药）

2025-05-17

·CPHI制药在线

3个1类创新药国内上市；最高超10亿美元！石药集团与Cipla就伊立替康脂质体注射液达成授权合作 | 制药在线一周药闻复盘

点击蓝字关注我们本周，热点很多。首先是审评审批方面，最值得关注的就是3个1类创新药国内上市，分别是北海康成的注射用维拉苷酶β、海思科的安瑞克芬注射液以及轩竹生物的吡洛西利片；其次是研发方面，多个药取得重要进展，其中，百济神州BTK降解剂又启动一项头对头礼来匹妥布替尼的Ⅲ期临床研究；最后是交易及投融资方面，交易很多，值得一提的是，石药集团就伊立替康脂质体注射液达成授权合作，总交易额超10亿美元。本期盘点包括审评审批、研发以及交易及投融资三大板块，统计时间为2025.5.12-5.16，包含28条信息。视频点个审评审批NMPA上市批准1、5月14日，NMPA官网显示，诺华的盐酸阿思尼布片获批上市，用于治疗新诊断的费城染色体阳性的慢性髓细胞白血病（Ph+CML）慢性期（CP）成人患者。阿思尼布是一款基于ABL肉豆蔻酰口袋（STAMP）创新机制的靶向药物，可实现深度缓解率翻倍和不良事件相关停药风险减半，延缓疾病进展，为CML患者提供了全新治疗选择。2、5月14日，NMPA官网显示，诺华的CDK4/6抑制剂瑞波西利片（商品名：凯丽隆）获批新适应症，适用于与芳香化酶抑制剂联合使用，作为激素受体（HR）阳性、人类表皮生长因子受体2（HER2）阴性高复发风险的早期乳腺癌患者的辅助治疗。3、5月15日，NMPA官网显示，北海康成1类新药注射用维拉苷酶β（商品名：戈芮宁）已通过优先审评审批程序批准上市，适用于12岁及以上青少年和成人Ⅰ型和Ⅲ型戈谢病患者的长期酶替代治疗。维拉苷酶β是一款针对戈谢病开发的酶替代疗法（ERT）。4、5月15日，NMPA官网显示，轩竹生物1类新药吡洛西利片（商品名：轩悦宁）获批上市，适用于激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性晚期或转移性乳腺癌成人患者：与氟维司群联合用于既往接受内分泌治疗后出现疾病进展的患者；单药用于既往转移性阶段接受过两种及以上内分泌治疗和一种化疗后出现疾病进展的患者。5、5月15日，NMPA官网显示，海思科1类新药安瑞克芬注射液（HSK21542）获批上市，用于治疗腹部手术后的轻、中度疼痛。安瑞克芬（HSK21542）是一款外周kappa阿片受体选择性激动剂。除了注射液剂型，海思科也在开发HSK21542的口服制剂，目前正在开展临床研究。申请6、5月12日，CDE官网显示，百济神州1类新药索托克拉片新适应症申报上市，拟用于治疗既往接受过抗CD20治疗和BTKi治疗的套细胞淋巴瘤（MCL）成人患者。索托克拉片的该项上市申请已经被CDE纳入优先审评。7、5月14日，CDE官网显示，勃林格殷格翰的口服选择性磷酸二酯酶4B（PDE4B）抑制剂那米司特片（nerandomilast）第二个适应症申报上市，用于治疗成人进展性肺纤维化（PPF）。2025年2月，首个适应症用于治疗成人特发性肺纤维化（IPF）的上市申请已递交。临床批准8、5月14日，CDE官网显示，信念医药的BBM-P002注射液获批临床。BBM-P002注射液利用AAV载体将多巴胺合成所需的表达基因递送到患者大脑壳核中持续表达，有望实现“一次给药、长期有效”的帕金森病治疗。9、5月14日，CDE官网显示，百济神州1类新药BGB-16673片获批两项临床，拟开发治疗慢性自发性荨麻疹。BGB-16673是一种口服靶向布鲁顿氏酪氨酸激酶（BTK）的嵌合式降解激活化合物（CDAC），是百济神州CDAC平台首款在研药物。10、5月14日，CDE官网显示，基石药业的注射用CS2009获批临床，用于晚期实体瘤。这是该药首次在国内获批临床。CS2009是一款同时靶向PD-1/VEGFA/CTLA-4三特异性抗体，在实体瘤治疗领域具有广阔的临床应用前景。优先审评11、5月14日，CDE官网显示，德国默克申报的盐酸匹米替尼胶囊（ABSK021胶囊）拟纳入优先审评，用于需要系统性治疗的腱鞘巨细胞瘤（TGCT）成人患者。匹米替尼是和誉医药研发的一种新型、口服、高选择性且高效的小分子CSF-1R抑制剂。德国默克拥有该产品的全球商业化权利。12、5月16日，CDE官网显示，科伦博泰申报的注射用芦康沙妥珠单抗拟纳入优先审评，用于既往接受过内分泌治疗且在晚期或转移性阶段接受过其他系统治疗的不可切除的局部晚期或转移性激素受体阳性（HR+）且人表皮生长因子受体2阴性（HER2-）乳腺癌成人患者。芦康沙妥珠单抗是一款新型TROP2靶向抗体偶联药物（ADC），此前已经在中国获批两项适应症。突破性疗法13、5月16日，CDE官网显示，和誉医药1类新药ABSK-011胶囊拟纳入突破性治疗，适应症为：经免疫检查点抑制剂（ICI）和多靶点酪氨酸激酶抑制剂（mTKI）治疗的成纤维细胞生长因子19（FGF19）过表达的晚期肝细胞癌（HCC）。ABSK-011是一款具有高选择性的FGFR4小分子抑制剂。FDA上市批准14、5月14日，FDA官网显示，艾伯维的c-Met靶向ADC药物telisotuzumab vedotin（Teliso-V，ABBV-399）获批上市，用于治疗既往接受过治疗的c-Met蛋白过表达、表皮生长因子受体（EGFR）野生型晚期/转移性非鳞状非小细胞肺癌（NSCLC）成人患者。该药物是c-Met赛道首款获批上市的ADC产品，也是艾伯维首款自研ADC产品。15、5月16日，FDA官网显示，中国生物制药与清普生物合作开发的非阿片类镇痛新药美洛昔康注射液（II）（商品名：QAMZOVA）获批上市。普坦宁不仅成为了中国首款一日一次24h长效的非甾体抗炎药（NSAID）注射液，也是中国首款获得FDA批准的镇痛新药和全球唯一在售的长效NSAID注射液。研发临床状态16、5月13日，正大天晴公布了1类新药盐酸安罗替尼胶囊联合派安普利单抗注射液一线治疗晚期肝细胞癌（HCC）的关键注册Ⅲ期临床（APOLLO研究）结果，一线治疗晚期HCC取得无进展生存期（PFS）和总生存期（OS）双终点阳性结果。安罗替尼联合派安普利单抗一线治疗晚期肝细胞癌已于2024年11月递交上市申请。17、5月13日，GSK和iTeos宣布，由于中期临床数据未能达到预期效果，双方决定终止合作开发TIGIT抗体belrestotug。该药物是GSK于2021年6月以6.25亿美元的预付款，最高可达14.5亿美元总里程碑付款从iTeos获得。双方将合作开发和推广TIGIT抗体Belrestotug，共同承担Belrestotug全球开发成本。18、5月15日，clinicaltrial官网显示，百济神州启动了一项Ⅲ期临床（CaDAnCe-304），旨在评估BGB-16673（200mg，每日1次）对比Pirtobrutinib（200mg，每日1次）治疗既往接受过共价BTK抑制剂（cBTKi）治疗的复发或难治性（R/R）慢性淋巴细胞白血病（CLL）或小淋巴细胞淋巴瘤（SLL）患者的疗效和安全性，主要终点是无进展生存期（PFS）。19、5月16日，诺诚健华宣布，其研发的ICP-332治疗非节段型白癜风的Ⅱ/Ⅲ期临床试验在中国完成首例患者给药。ICP-332是一款在研的1类创新药，是高效、高选择性的新型口服TYK2抑制剂，正在被开发用于治疗各种T细胞相关的自身免疫性疾病，包括白癜风、特应性皮炎、结节性痒疹等。20、5月16日，信达生物宣布，胰高血糖素（GCG）/胰高血糖素样肽-1（GLP-1）双受体激动剂玛仕度肽在中国超重或肥胖合并代谢相关脂肪性肝病（MAFLD）受试者中的一项Ⅲ期临床（GLORY-3）完成首例受试者给药。本研究是一项在中国超重或肥胖合并MAFLD受试者中比较玛仕度肽与一款GLP-1单受体激动剂有效性和安全性的多中心、随机、开放标签的Ⅲ期临床研究（NCT06884293）。临床数据21、5月11日，礼来公布了SURMOUNT-5研究的详细结果。该研究是一项开放标签Ⅲb期临床，旨在针对肥胖或伴有至少一种合并症（如高血压、血脂异常、阻塞性睡眠呼吸暂停、心血管疾病）的超重成人（且不合并糖尿病）患者，评估GIP/GLP-1双受体激动剂替尔泊肽与GLP-1单受体激动剂司美格鲁肽的有效性与安全性。替尔泊肽组平均体重减轻了50.3磅（22.8公斤），司美格鲁肽组平均体重减轻了33.1磅（15.0公斤）。22、5月12日，诺和诺德公布了Ⅲ期REAL8篮子试验的数据，结果显示：每周给药一次的Sogroya在改善小于胎龄儿（SGA）、努南综合征（NS）、特发性矮小症（ISS）的青春期前儿童的年生长速率（通过52周时身高生长速度HV测量）方面，与每日给药一次的生长激素Norditropin相当。此外，在患有努南综合征（NS）的儿童中，Sogroya较每日一次的生长激素具有优越性，同时在小于胎龄儿（SGA）的儿童中，Sogroya较每日低剂量的生长激素也具有优越性。23、5月13日，邦耀生物公布了CRISPR/Cas9基因编辑的异体抗CD19CAR-T细胞（TyU19）治疗复发/难治性系统性红斑狼疮（SLE）数据。研究结果表明，TyU19细胞在SLE治疗中可实现快速、深度的临床缓解，同时展现出优异的临床安全性。24、5月16日，爱科百发宣布，其开发的新一代抗纤维化药物AK3280的Ⅱ期验证性临床研究取得积极成果。AK3280是基于已有的IPF药物结构优化的新一代抗纤维化药物，临床前数据显示其抗纤维化作用更强，药代动力学更佳，有望改善现有药物的胃肠道耐受性和其他毒副作用。交易及投融资25、5月14日，GSK宣布，与BostonPharmaceuticals达成协议，将收购其主要资产efimosferminalfa。根据协议，GSK将支付高达20亿美元的现金对价总额，包括12亿美元的预付款和高达8亿美元的里程碑付款。GSK还将向诺华支付该药物的分级特许权使用费。该药是一种可每月1次皮下注射给药的潜在同类最佳FGF21（成纤维细胞生长因子21）长效类似物。26、5月14日，诺和诺德宣布，与Septerna达成一项独家全球合作，双方将共同致力开发并商业化针对肥胖症、2型糖尿病及其他心脏代谢疾病的口服小分子药物。根据协议，Septerna将有资格从诺和诺德获得总计约22亿美元的付款，包括首付款及研发、商业化里程碑款项，其中超过2亿美元为预付款及近期里程碑付款。Septerna还可获得上市产品的分层特许权使用费。诺和诺德将承担合作项目的全部研发费用。27、5月15日，石药集团宣布，与Cipla就伊立替康脂质体注射液达成协议。根据协议，石药同意授予Cipla独家许可。石药将收取1500万美元首付款，最高达2500万美元潜在首次商业销售及最高达10.25亿美元的里程碑付款。该产品为一种拓朴异构酶1抑制剂，含有43mg/10ml伊立替康。目前用于治疗多种实体瘤，如转移性、结直肠癌、肺癌及宫颈癌等。28、5月16日，科霸生物宣布，已与三菱田边制药签署合作协议。双方将围绕一个全球首创的免疫细胞类靶点。科霸生物率先提出并实践了一种全新的ADC开发理念，即靶向肿瘤免疫微环境中的免疫细胞受体，尤其是大量存在的髓系抑制细胞、肿瘤相关巨噬细胞（TAM）等关键免疫抑制性细胞类型。END领取CPHI & PMEC China 2025展会门票【智药研习社直播预告】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

上市批准优先审批临床3期申请上市

2025-05-13

·FiercePharma

Novo heads to regulators after Sogroya matches predecessor Norditropin in 3 pediatric growth disorders

The FDA first approved Sogroya in August 2020 as a once-weekly treatment for adult growth hormone deficiency. The drug’s label was expanded to include children in April 2023. With a late-stage trial win for its Norditropin heir in hand, Novo Nordisk is making good on plans to boost its profile in the realm of rare disease.Over the weekend, Novo unveiled data from the phase 3 Real8 study, which found that the company’s once-weekly human growth hormone analogue Sogroya was largely on par with its daily predecessor, Norditropin, in a trio of growth disorders in kids.At the basket study’s 52-week mark, Sogroya—first approved in 2020—proved noninferior to Norditropin at improving yearly growth rate in prepubescent children with idiopathic short stature (ISS).Meanwhile, Sogroya demonstrated superiority over Novo’s daily growth hormone in children with Noonan syndrome (NS) and in children born small for gestational age (SGA) when compared to a lower Norditropin dose.When pitted against a higher dose of its growth hormone predecessor in SGA, Sogroya’s efficacy was noninferior, Novo explained in its Monday release.Sogroya was well tolerated in the study, and no new safety flags cropped up that diverged from Norditropin’s long-established profile, the company added.Sogroya’s performance in Real8 allowed the first three sub-studies to meet their primary endpoints. Leveraging data from Real8 and Real9, Novo said it has already filed for approval of Sogroya in SGA, NS and ISS with regulators in the U.S. and Europe.Novo’s Real8 program is also testing Sograya’s mettle in Turner syndrome, though those data won’t arrive until “later this year,” the company said. The FDA first approved Sogroya in August 2020 as a once-weekly treatment for adult growth hormone deficiency. The drug’s label was expanded to include children in April 2023.Sogroya is meant to succeed Novo’s once-a-day growth hormone Norditropin, which has now been on the market for decades. Eli Lilly, Merck & Co. and Pfizer all sell their own daily growth disorder drugs, while newer meds like Ascendis’ Skytrofa and Pfizer’s Ngenla are challenging Sogroya directly on the weekly-dosing front.Novo lumps sales of Norditropin and Sogroya together into its rare endocrine disorders category, which grew sales 31% in 2024 to roughly 5 billion Danish kroner ($745 million).Analytics firm GlobalData has forecast Sogroya will hit $294 million in 2030 sales and expects Norditropin to reach $960 million in sales that same year. The Sogroya results have likely bolstered Novo’s confidence in rare disease, where the company has been playing a “long endgame” since the late 2010s, Ludovic Helfgott, the company’s executive vice president of rare disease, said in a March interview with Fierce Pharma.Aside from drugs for growth disorders like Norditropin and Sogroya, Novo’s rare disease pedigree includes treatments for blood disorders like Esperoct, NovoEight or the recently approved daily hemophilia injection Alhemo, Helfgott explained.Novo plans to stick to those two major disease areas—growth and blood disorders—as it presses forward in the field.“It’s our core, and we will continue to develop this both internally and externally,” Helfgott said.

临床3期上市批准临床结果

2025-05-13

·药智网

诺和诺德公布Sogroya的III期数据

在儿童生长发育领域，小于胎龄儿（SGA）、努南综合征（NS）、特发性矮小症（ISS）等疾病一直是困扰诸多家庭的难题，传统的每日一次生长激素治疗虽有一定效果，但患者依从性不佳等问题限制了其疗效的充分发挥。然而，5月12日，诺和诺德公布的一项重磅研究成果——其每周一次生长激素Sogroya（somapacitan）III期REAL8篮子试验数据，为这一困境带来了新的曙光，开启了每周一次生长激素治疗的新篇章。Sogroya是一种人生长激素类似物，采用白蛋白结合延长技术，这一独特技术使得Sogroya能够附着在血液中的白蛋白上，从而延缓其清除速度，发挥更长时间的作用，为患者提供更加便捷的治疗选择。而此次的III期REAL8篮子试验更是采用了创新的研究设计，它并非针对单一适应证进行研究，而是在同一试验方案下，同时研究Sogroya在SGA、特纳综合征（TS）、NS和ISS四种不同但相关的适应证中的应用。在研究过程中，Sogroya与传统的每日一次生长激素Norditropin进行了严谨的对比。研究对象涵盖了SGA、NS、ISS的青春期前儿童，通过52周时身高生长速度HV测量年生长速率，以科学、客观的方式评估Sogroya的疗效。结果显示，在SGA儿童中，与低剂量Norditropin相比，Sogroya的估算年平均身高生长速率HV更优，达到11.0厘米/年，相较于Norditropin的9.4厘米/年展现出显著优势；与高剂量Norditropin相比，Sogroya也达到了非劣效性标准，分别为11.0厘米/年与11.1厘米/年，疗效相当。在NS儿童中，Sogroya的估算年平均HV为10.4厘米/年，优于Norditropin的9.2厘米/年。而在ISS儿童中，两者估算年平均HV均为10.5厘米/年，Sogroya与Norditropin的疗效相当。除了令人瞩目的疗效数据，Sogroya的安全性同样值得关注。REAL8研究显示，Sogroya耐受性良好，与每日一次的生长激素相比，并未发现安全性和耐受性问题。从患者的角度来看，每周一次的Sogroya给药方案无疑是一个巨大的福音。传统的每日一次生长激素治疗，需要患者或家长每天进行注射，这不仅给患者带来了身体上的不适，如注射部位的疼痛等，还增加了心理负担，容易导致患者产生抵触情绪，进而影响治疗依从性。而Sogroya的每周一次给药方式，极大地减轻了家长和孩子的负担，提高了治疗的依从性。目前，诺和诺德已在欧盟和美国提交了Sogroya三种适应症的监管审查申请。结语：诺和诺德公布的Sogroya III期REAL8篮子试验数据，以其显著的疗效、良好的安全性以及创新的研究设计，为儿童生长障碍的治疗带来了革命性的变革。参考来源：1.https://news.qq.com/rain/a/20250512A08XZQ002.https://mp.weixin.qq.com/s/vMFpisn35zScmbOGsqZ2hA声明：本内容仅用作医药行业信息传播，不代表药智网立场。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 史蒂文合作、投稿 | 马老师 18323856316（同微信）阅读原文，是受欢迎的文章哦

临床3期临床成功

100 项与重组人生长激素(Novo Nordisk A/S) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	重组人生长激素(Novo Nordisk A/S)	H01AC01	DB00052

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
生长障碍	中国	Novo Nordisk A/S	1999-06-22
生长激素缺乏症	中国	Novo Nordisk A/S	1999-06-22
侏儒症	日本	Novo Nordisk Pharma Ltd.	1991-01-18
垂体性侏儒症	日本	Novo Nordisk Pharma Ltd.	1988-11-30

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
代谢性骨病	临床3期	法国	Novo Nordisk A/S	2013-03-01
青春期延迟	临床3期	法国	Novo Nordisk A/S	2013-03-01
胎儿生长受限	临床3期	日本	Novo Nordisk A/S	2004-08-18
小于胎龄儿	临床3期	日本	Novo Nordisk A/S	2004-08-18
运动损伤	临床2期	美国	Novo Nordisk A/S	2019-10-08
脑震荡	临床2期	美国	Novo Nordisk A/S	2019-10-08
青少年脊髓性肌萎缩症	临床2期	德国	Novo Nordisk A/S	2007-10-01

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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


ESPE2015	N/A	特纳综合症	-	Recombinant GH	鑰膚醖鏇淵範鹽獵製鹽(簾壓膚鹹蓋構選積淵齋) = she started treatment with acetazolamide with good effect 構齋製醖範蓋憲淵顧顧 (積鏇廠壓範壓淵鬱願鏇 ) 更多	-	2015-10-01
Pubmed \| Patient Prefer Adherence	临床4期	-	103	Norditropin NordiFlex	淵鏇蓋壓醖糧襯壓糧窪(夢築艱糧製齋積鏇獵鬱) = 夢願築築糧鹹鏇繭壓糧艱淵積糧鑰淵糧夢範積 (鬱繭壓鹽鹽鹹遞獵衊製 ) 更多	-	2013-05-01