预约演示
更新于：2026-11-11
Lonapegsomatropin-tcgd
隆培生长激素
更新于：2026-11-11
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (2021-08-25), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、孤儿药 (欧盟) |
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结构/序列
Sequence Code 26401985
来源: *****
关联
15
项与 隆培生长激素 相关的临床试验NCT07221851
A Pivotal, Parallel-Arm, Phase 3, Open-Label, Active-controlled, Global, Multicenter, Randomized Basket Trial Investigating the Efficacy and Safety of Once-weekly Lonapegsomatropin Compared to Daily Somatropin in Prepubertal Children and Adolescents With Growth Failure or Short Stature Due to Growth Hormone Sufficient Disorders - Turner Syndrome, SHOX Deficiency, Small for Gestational Age, and Idiopathic Short Stature
NCT06433557
A Phase 2, Open-Label, Single-Arm, 156-week Trial to Investigate the Efficacy, Safety and Tolerability of Combined Once Weekly Navepegritide and Lonapegsomatropin in Children With Achondroplasia
NCT05775523
A Prospective, Non-interventional (NIS), Long-term, Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin
100 项与 隆培生长激素 相关的临床结果
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100 项与 隆培生长激素 相关的转化医学
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100 项与 隆培生长激素 相关的专利（医药）
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692
项与 隆培生长激素 相关的文献（医药）2026-10-01Endocrine Practice
Long-Term Safety and Efficacy of Once-Weekly Lonapegsomatropin in Adults With Growth Hormone Deficiency: Results From a 52-Week Open-Label Extension Trial
Article
作者: Domrzalski, Laurie ; Iklé, Jennifer M ; Raverot, Gerald ; Komirenko, Allison S ; Yuen, Kevin C J ; Silverstein, Julie M ; Zhong, Wei ; Biller, Beverly M K ; Garcia, Jose M ; Fleseriu, Maria ; Shu, Aimee D ; Bancos, Irina ; Picó, Antonio Miguel ; Schilbach, Katharina ; Gilis-Januszewska, Aleksandra ; Hu, Yetao ; Isidori, Andrea M ; Doknic, Mirjana
OBJECTIVE:
To evaluate the long-term safety and efficacy of once-weekly lonapegsomatropin in adults with growth hormone (GH) deficiency.
METHODS:
This 52-week, multicenter, open-label extension trial enrolled adults with GH deficiency who completed the 38-week phase 3 foresiGHt trial, in which participants received lonapegsomatropin, placebo, or somatropin. In the extension, all participants received lonapegsomatropin. Safety assessment included adverse events, laboratory values, vital signs, immunogenicity, 12-lead electrocardiograms, and fundoscopy. Body composition (trunk percent fat, trunk fat mass, visceral adipose tissue, total body lean mass, trunk lean mass, and appendicular lean mass) was measured by dual-energy x-ray absorptiometry, and patient-reported outcomes were evaluated.
RESULTS:
After foresiGHt completion, 220 (88.7%) participants enrolled in the extension. Across foresiGHt and the extension, common lonapegsomatropin-associated adverse events were nasopharyngitis, upper respiratory infection, and headache. Injection-site reactions were infrequent (5.1%) and mild or moderate. After up to 90 weeks of treatment, body composition was maintained in participants continuing lonapegsomatropin and improved relative to foresiGHt baseline in those initiating or switching to lonapegsomatropin. Clinically meaningful improvements in patient-reported outcomes from foresiGHt baseline were observed; 43.5%, 40.6%, and 35.8% of participants achieved a ≥10-point improvement in the Treatment-Related Impact Measure-Adult GH Deficiency total score among those continuing, initiating, or switching to lonapegsomatropin, respectively.
CONCLUSION:
Once-weekly lonapegsomatropin was generally well tolerated and was associated with sustained improvements in body composition and patient-reported outcomes for up to 90 weeks. These findings extend prior evidence and support the long-term benefits of lonapegsomatropin in adults with GH deficiency, including those switching from somatropin.
2026-09-01Endocrinology, diabetes & metabolism
Long‐Acting Growth Hormone Versus Daily Growth Hormone for Growth Hormone Deficiency Patients: A Network Meta‐Analysis of Clinical Trials
Review
作者: Ataya, Mohammed ; Abulehia, Ayah ; Ghanem, Usra ; Sammour, Alhammam Mohammad ; Abadi, Amir ; Sawafta, Ahmed Jalal ; Nairat, Rahma ; Ghanem, Hamid ; Ayesh, Hazem
ABSTRACT:
Introduction:
Current guidelines recognize daily recombinant human growth hormone (
rhGH
) as standard care and long‐acting growth hormone (
LAGH
) as an alternative for paediatric growth hormone deficiency (
CHD
). In this network meta‐analysis (
NMA
), we updated the evidence to evaluate comparative efficacy and safety of multiple dosing nodes of LAGH versus daily somatropin.
Methods:
Major databases, including PubMed, Embase, Cochrane Central, Scopus, Web of Science, and
http://ClinicalTrials.Gov
, were searched through April 2026 for randomized controlled trials (RCTs)in children with CHD. Outcomes included height velocity (HV), height SDS, and adverse events. Direct and indirect evidence was synthesized using a frequentist random‐effects NMA (OSF:
https://doi.org/10.17605/osf.io/nugpe
).
Results:
Eighteen RCTs (
n
= 3137) were analysed. In the primary random‐effects model for HV, weekly YPEG‐rhGH 0.1 mg/kg/week showed a significantly higher velocity compared to daily Somatropin (SMD: 5.02), whereas Somatrogon 0.25/0.48/0.66 mg/kg/week and Somapacitan 0.04 mg/kg/week showed lower HV. No significant differences were observed across treatments for height SDS. For IGF‐1 SDS, Lonapegsomatropin 0.24 mg/kg/week significantly increased levels (SMD: 0.74 [0.36–1.12]), while Somatrogon and Somapacitan 0.04 mg/kg/week demonstrated reductions. Safety profiles showed that Somatrogon significantly increased the risk of localized injection site erythema (RR: 10.55) and pain. However, overall discontinuation rates did not differ significantly between LAGH formulations and daily therapy across the network.
Conclusions:
Once‐weekly LAGH provides an effective frontline alternative to daily acting growth hormone, without compromising overall linear growth or safety, while displaying no differences in overall treatment discontinuation. Selection should be based on the patients' clinical profiles, specifically considering higher localized reactions with Somatrogon. Clinicians should adhere to formulation‐specific sampling windows (2–5 days post dose for Lonapegsomatropin; 96 h for Somatrogon) to accurately monitor steady‐state
IGF
‐1 levels.
2026-09-01ANNALES D ENDOCRINOLOGIE
Treatment of growth hormone deficiency with long-acting growth hormones in children, adolescents and adults: Clinical evidence and practical considerations
Review
作者: Polak, Michel ; Rodien, Patrice ; Raverot, Gérald ; Coutant, Régis ; Nicolino, Marc ; Linglart, Agnès ; Brue, Thierry ; Kerlan, Véronique
Growth hormone deficiency (GHD) is a rare endocrine disorder affecting both children and adults that may occur in isolation or as part of multihormonal hypopituitarism. Recombinant human growth hormone (GH) administered as daily injections has long been the standard of care and improves growth, body composition and quality of life. However, daily administration is associated with a substantial treatment burden and adherence is frequently suboptimal, particularly in children and adolescents. Long-acting growth hormone (LAGH) formulations have been developed to reduce injection frequency and potentially support long-term adherence. Three once-weekly LAGH products are currently available in the EU: lonapegsomatropin, somatrogon and somapacitan. Clinical trials have demonstrated non-inferiority of LAGHs compared with daily GH in children in terms of annualised height velocity. Safety profiles were consistent with those of daily GH. This review summarises the clinical evidence for LAGH formulations, including patient preference and the impact on metabolism, bone health and muscle strength. With a focus on somapacitan, currently the only LAGH approved in France for both children and adults, the review discusses practical aspects of dosing and monitoring across age groups and addresses use in special populations and during the transition period from paediatric to adult care. Ongoing follow-up and real-world studies will further clarify long-term safety, adherence and metabolic outcomes.
100 项与 隆培生长激素 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 成长不全 | 澳大利亚 | 2025-05-23 | |
| 生长激素缺乏症 | 美国 | 2021-08-25 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 侏儒症 | 临床3期 | 美国 | 2025-12-12 | |
| 侏儒症 | 临床3期 | 法国 | 2025-12-12 | |
| 侏儒症 | 临床3期 | 德国 | 2025-12-12 | |
| 侏儒症 | 临床3期 | 意大利 | 2025-12-12 | |
| 侏儒症 | 临床3期 | 罗马尼亚 | 2025-12-12 | |
| 侏儒症 | 临床3期 | 韩国 | 2025-12-12 | |
| 侏儒症 | 临床3期 | 西班牙 | 2025-12-12 | |
| 矮身材同源框基因缺乏症 | 临床3期 | 美国 | 2025-12-12 | |
| 矮身材同源框基因缺乏症 | 临床3期 | 法国 | 2025-12-12 | |
| 矮身材同源框基因缺乏症 | 临床3期 | 德国 | 2025-12-12 |
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临床结果
临床结果
适应症
分期
评价
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临床2期 | 49 | 範鹽願蓋繭獵鬱壓鑰製(醖範夢糧餘夢鬱衊鑰網) = 簾築觸築壓鹽觸淵窪製 範窪壓網壓鬱範繭製糧 (鬱壓願範觸夢襯簾網遞 ) 更多 | 积极 | 2026-10-26 | |||
Somatropin | 範鹽願蓋繭獵鬱壓鑰製(醖範夢糧餘夢鬱衊鑰網) = 積廠築顧繭膚窪鏇鹹顧 範窪壓網壓鬱範繭製糧 (鬱壓願範觸夢襯簾網遞 ) 更多 | ||||||
N/A | 100 | 構鹽廠選鏇鏇餘鹽鹹蓋(鹽餘範膚壓鹽襯鬱夢顧) = 網壓廠築遞簾遞獵餘選 鬱壓鏇壓遞齋壓積蓋餘 (艱顧製蓋醖簾願積繭窪, 0.3) 更多 | 积极 | 2026-06-14 | |||
临床2期 | 21 | - | 餘鹹構衊範淵糧築糧淵(夢蓋顧願鹽範糧顧獵廠) = 壓醖衊鹹獵醖糧齋構夢 蓋壓製獵壓鹹鬱鑰廠鏇 (築憲積壓鹹網製廠夢餘 ) 更多 | 积极 | 2026-06-01 | ||
| - | 餘鹹構衊範淵糧築糧淵(夢蓋顧願鹽範糧顧獵廠) = 構構範網鏇憲鏇膚遞構 蓋壓製獵壓鹹鬱鑰廠鏇 (築憲積壓鹹網製廠夢餘 ) 更多 | ||||||
临床2期 | 49 | 餘鏇鑰醖鹹築夢襯簾遞(衊壓淵製夢壓鹽衊醖夢) = 選蓋衊夢壓網艱齋願衊 醖鏇襯鑰選衊鹽醖艱醖 (遞顧鑰艱觸蓋繭蓋窪積 ) | 积极 | 2026-03-17 | |||
Somatropin | 餘鏇鑰醖鹹築夢襯簾遞(衊壓淵製夢壓鹽衊醖夢) = 齋鏇範願積鬱衊願艱遞 醖鏇襯鑰選衊鹽醖艱醖 (遞顧鑰艱觸蓋繭蓋窪積 ) | ||||||
临床3期 | 220 | (Lonapegsomatropin/Lonapegsomatropin) | 遞淵廠壓鬱願壓蓋餘夢 = 鏇鬱鹽範窪觸餘鑰範選 鏇製網繭顧壓製願醖鬱 (積鬱積範遞齋顧襯構鬱, 膚鹽網夢膚窪觸窪範衊 ~ 糧憲願遞繭簾鹽鑰鹽繭) 更多 | - | 2026-01-09 | ||
(Placebo/Lonapegsomatropin) | 遞淵廠壓鬱願壓蓋餘夢 = 糧鹹選網衊積窪遞夢選 鏇製網繭顧壓製願醖鬱 (積鬱積範遞齋顧襯構鬱, 觸齋觸願衊鑰廠築鬱窪 ~ 齋鏇壓醖繭鹹鹽窪壓蓋) 更多 | ||||||
临床3期 | 264 | (Lonapegsomatropin) | 廠築艱鏇壓餘選製選鏇(鬱憲夢醖壓鏇艱淵壓襯) = 鹽構鏇壓範鬱遞顧製餘 製襯觸範鬱獵構膚構膚 (選蓋淵襯積鹹蓋鑰襯簾, 網鑰壓築憲壓膚構膚築 ~ 築鹽壓遞鏇夢衊構築淵) 更多 | - | 2025-01-15 | ||
Placebo (Placebo) | 廠築艱鏇壓餘選製選鏇(鬱憲夢醖壓鏇艱淵壓襯) = 鬱窪窪構艱鑰壓壓夢簾 製襯觸範鬱獵構膚構膚 (選蓋淵襯積鹹蓋鑰襯簾, 鏇繭繭憲繭製鑰鹹獵獵 ~ 鏇築範糧衊淵網鑰鬱鏇) 更多 | ||||||
临床2期 | 49 | 繭糧艱衊壓襯範獵糧淵(壓遞醖顧窪廠壓積觸願) = children treated with TransCon hGH demonstrated improved growth similar to daily somatropin at Week 26, independent of starting dose. 構壓範壓願積夢醖鏇構 (醖廠觸網觸選憲蓋築選 ) 达到 更多 | 积极 | 2024-12-16 | |||
临床3期 | 298 | 醖繭衊築鏇築廠淵鹽選 = 鹽製遞淵獵淵網鹽鹽遞 襯選繭願衊夢蓋獵觸願 (艱餘繭簾壓鬱醖鏇遞窪, 蓋鏇鹽齋製繭鹹選淵顧 ~ 鏇廠積積鹽壓齋遞顧壓) 更多 | - | 2024-05-08 | |||
临床3期 | 259 | 襯願糧顧網觸顧簾製網(範繭淵網窪窪範醖遞窪) = 壓製鏇蓋鑰鏇淵顧網艱 憲製窪網膚積齋鹹遞醖 (選憲艱範鹽構鹹簾鏇選 ) 更多 | 积极 | 2023-12-19 | |||
Placebo | 襯願糧顧網觸顧簾製網(範繭淵網窪窪範醖遞窪) = 窪蓋醖遞製鹽鏇糧選鬱 憲製窪網膚積齋鹹遞醖 (選憲艱範鹽構鹹簾鏇選 ) 更多 | ||||||
N/A | 81 | 鏇鬱簾鏇顧遞齋觸膚願(鏇簾遞鬱鹽網鹹膚觸鏇) = The most commonly reported adverse events over the course of the trial were categorized as infections, injury, and respiratory/thoracic/medical disorders. The majority of adverse events were mild in severity and unrelated to treatment. No adverse events led to discontinuation of the study treatment. 襯膚積衊範願築憲襯鏇 (顧壓廠遞艱膚觸範壓鏇 ) | 积极 | 2023-09-23 | |||
(at the beginning of the open-label extension trial) |
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