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更新于：2025-12-03
Lonapegsomatropin-tcgd
隆培促生长素
更新于：2025-12-03
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)申请上市 |
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 隆培促生长素 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 隆培促生长素 相关的临床结果
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100 项与 隆培促生长素 相关的转化医学
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100 项与 隆培促生长素 相关的专利（医药）
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676
项与 隆培促生长素 相关的文献（医药）2025-10-01JOURNAL OF ASSISTED REPRODUCTION AND GENETICS
Effectiveness of hormone add-on strategies in ovarian stimulation for women with poor ovarian response: a systematic review and network meta-analysis of randomized controlled trials
Review
作者: Riemma, Gaetano ; De Franciscis, Pasquale ; Fuentes Rozalén, Ana ; Bernabeu Garcia, Andrea ; Etrusco, Andrea ; Castillo Farfán, Juan Carlos ; Laganà, Antonio Simone ; Agrifoglio, Vittorio ; Moliner Renau, Belén ; D’Amato, Antonio
Abstract:
Purpose:
Despite various stimulation protocols and adjuvant treatments, optimizing the reproductive success of women with poor ovarian response (POR) undergoing assisted reproduction techniques (ART) remains a challenge. The aim was to evaluate and compare the ovarian stimulation and reproductive outcomes of hormonal add-ons in women with POR undergoing ART.
Methods:
MEDLINE, LILACS, SCOPUS, EMBASE, Scielo.br, PROSPERO, CINAHL, PsycINFO, AMED, Clinicaltrials.gov, ICTRP, Cochrane Library, and conference proceedings were searched for randomized controlled trials without temporal, geographic, and language restrictions. We included only RCTs that allocated women with POR, according to Bologna criteria, undergoing ART to at least two different ovarian stimulation protocols, with the treatment arm including at least one hormonal add-on. A random-effect network meta-analysis was performed for mixed multiple treatment comparisons to rank available add-ons by the surface under the cumulative ranking curve area (SUCRA). Primary outcome was the live birth rate.
Results:
Twenty-two studies (4131 women) were directly and indirectly compared. Concerning the live birth rate, no significant differences among add-ons were noted (very low evidence), with testosterone (SUCRA = 34.0%) showing the highest probability of the best treatment. For the clinical pregnancy rate, according to SUCRA ranking, human growth hormone (SUCRA = 46.3%) and testosterone (SUCRA = 44.6%) had increased chances of being ranked first, with growth hormone being significantly more efficacious than estrogens (OR 3.46 [95% CI 1.59 to 7.53]; low evidence) while recombinant luteinizing hormone was significantly less efficacious (OR 0.50 [95% CI 0.26 to 0.96]; very low evidence). Regarding the overall number of retrieved oocytes and the mean number of metaphase II oocytes, human growth hormone was confirmed best ranked (SUCRA = 53.2% and SUCRA = 67.9%). Letrozole had significantly less gonadotropins used than controls (SMD – 7.02 [95% CI − 12.82 to − 1.22]; low evidence) (SUCRA = 67.0%) and the smallest stimulation duration (SUCRA = 52.0%).
Conclusion:
Low to very-low evidence shows that women with POR undergoing controlled ovarian stimulation may benefit from adding human growth hormone or testosterone for improved reproductive outcomes. However, additional high-quality randomized controlled trials are needed to overcome the limitations of the current literature.Trial registration: PROSPERO CRD42024618797, date: 25 November 2024.
2025-08-01Endocrine Practice
Early U.S. Real-World Treatment Patterns and Outcomes in Palopegteriparatide Treatment for Patients With Hypoparathyroidism
Article
作者: Sibley, Christopher T ; Edelson, Gary ; Ing, Steven W ; Abbott, Lisa ; Zhao, Carol ; Cusano, Natalie E ; Lubitz, Sara ; Ukena, Jenny ; Rubin, Mishaela R ; Haider, Adnan ; Schneider, Mark ; Graham, Timothy ; Rothman, Micol S ; Shoback, Dolores M
OBJECTIVE:
To examine the impact of palopegteriparatide (YORVIPATH; TransCon PTH) on real-world clinical outcomes in adult patients with hypoparathyroidism.
METHODS:
Adult patients with hypoparathyroidism who enrolled in the U.S. expanded access program as of October 2024 and provided consent were included in the analysis. Palopegteriparatide was administered at a recommended starting dose of 18 μg/day and titrated alongside conventional therapy (calcitriol and calcium). Conventional therapy requirements, palopegteriparatide dosing, serum calcium levels, and adverse events were assessed up to 12 months of treatment.
RESULTS:
Among 135 patients enrolled in the expanded access program who received at least 1 dose of palopegteriparatide, 123 provided consent for data use and were included in analysis. Nearly all patients (95.1%, 117/123) were previously treated with short-lived parathyroid hormone (PTH) therapy (primarily teriparatide or recombinant human PTH [1-84]), and 50.4% (62/123) switched directly from short-lived PTH or PTH-related protein therapy to palopegteriparatide. There was no clinically meaningful difference (>3 μg) in palopegteriparatide dose between direct switch and nondirect switch patients, with a similar trend over time. With palopegteriparatide treatment, the proportion of patients achieving independence from conventional therapy (defined as taking no calcitriol and ≤600 mg/day of elemental calcium) increased over 12 months. Mean serum calcium levels remained within the reference range (8.3-10.6 mg/dL) with palopegteriparatide, and no new safety signals were identified with up to 12 months of treatment.
CONCLUSION:
This real-world analysis of palopegteriparatide treatment of hypoparathyroidism outside of a clinical trial setting reaffirms its efficacy and safety profile and provides insights into outcomes associated with different treatment transition practices.
2025-03-26JOURNAL OF PEDIATRIC ENDOCRINOLOGY & METABOLISM
Clinical outcomes of switching to lonapegsomatropin from somatropin for treatment of pediatric growth hormone deficiency
Article
作者: Coyne, Emma ; Muthuvel, Gajanthan ; Gutmark-Little, Iris
Abstract:
Objectives:
This study aimed to assess differences in insulin-like growth factor 1 (IGF-1) levels following the transition from somatropin to lonapegsomatropin in patients with pediatric growth hormone deficiency (GHD). Secondary objectives included the evaluation of dose titrations based on IGF-1 levels, changes in annualized height velocity (AHV) and body mass index (BMI), and assessing reported adverse effects associated with lonapegsomatropin therapy.
Methods:
A single-center, retrospective review was conducted including patients diagnosed with pediatric GHD initially treated with somatropin who transitioned to lonapegsomatropin between January 1, 2022, and December 31, 2023.
Results:
Fourteen patients (median age: 9 years) were included. The median somatropin dose was 0.18 mg/kg/week (range, 0.09 to 0.29) at the time of transition and patients were initiated on a median lonapegsomatropin dose of 0.23 mg/kg/week (range, 0.15 to 0.26). This resulted in an IGF-1 increase of 2.3 SDS post-switch. Dose adjustments were made based on IGF-1 levels. Five patients required immediate dose reductions; four of these required further adjustments due to persistent elevation. There were no serious adverse effects reported.
Conclusions:
Lonapegsomatropin may be a favorable option to reduce injection burden for those with pediatric GHD, though the manufacturer’s recommended starting dose of 0.24 mg/kg/week may require individualization. Careful monitoring and dose adjustment based on IGF-1 levels are necessary to maintain safety and efficacy.
100 项与 隆培促生长素 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 | - | 2025-11-01 | |
| 矮身材同源框基因缺乏症 | 临床3期 | - | 2025-11-01 | |
| 特纳综合症 | 临床3期 | - | 2025-11-01 | |
| 内分泌系统疾病 | 临床3期 | 中国 | 2019-12-30 | |
| 内分泌系统疾病 | 临床3期 | 中国 | 2019-12-30 | |
| 桥本病 | 临床3期 | 中国 | 2019-12-30 | |
| 桥本病 | 临床3期 | 中国 | 2019-12-30 | |
| 垂体疾病 | 临床3期 | 中国 | 2019-12-30 | |
| 垂体疾病 | 临床3期 | 中国 | 2019-12-30 | |
| 软骨发育不全 | 临床2期 | 丹麦 | 2024-07-26 |
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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3期 | 264 | (Lonapegsomatropin) | 夢鹹觸鬱築鬱餘鹽網醖(窪鏇構觸範襯窪獵窪夢) = 網窪網廠襯獵鏇膚製顧 憲鹽鑰淵願構餘獵餘觸 (夢糧遞顧構鹽觸衊憲襯, 糧糧鏇繭艱鑰憲選觸衊 ~ 簾鏇壓獵繭範構構廠簾) 更多 | - | 2025-01-15 | ||
Placebo (Placebo) | 夢鹹觸鬱築鬱餘鹽網醖(窪鏇構觸範襯窪獵窪夢) = 願淵積鏇觸積齋積選蓋 憲鹽鑰淵願構餘獵餘觸 (夢糧遞顧構鹽觸衊憲襯, 蓋簾繭顧窪鹹鏇鹽製淵 ~ 獵窪鏇鏇顧餘襯鑰獵觸) 更多 | ||||||
临床2期 | 49 | 簾衊餘醖淵壓鏇膚蓋窪(鏇壓窪糧蓋選網齋獵願) = children treated with TransCon hGH demonstrated improved growth similar to daily somatropin at Week 26, independent of starting dose. 簾鹹鏇齋網鹽鬱願壓蓋 (齋淵繭衊鑰繭糧築蓋選 ) 达到 更多 | 积极 | 2024-12-16 | |||
临床3期 | 298 | 鹹顧蓋鹹觸選醖積窪繭 = 鹹醖鹹窪築製願繭鑰鹹 獵淵醖廠淵艱積顧憲鹹 (艱窪鹽鹹築顧窪襯蓋壓, 遞鏇鏇築遞壓廠構鹽遞 ~ 觸繭鹽構鬱製鏇鏇選餘) 更多 | - | 2024-05-08 | |||
临床3期 | 259 | 遞夢觸築餘膚選獵鬱蓋(壓憲衊觸膚襯糧壓觸積) = 顧醖鹽築願艱繭鏇鏇積 遞糧鹽鏇顧鑰餘壓製願 (餘鹽範積醖鬱獵築顧鏇 ) 更多 | 积极 | 2023-12-19 | |||
Placebo | 遞夢觸築餘膚選獵鬱蓋(壓憲衊觸膚襯糧壓觸積) = 顧積窪鏇壓顧醖鏇獵憲 遞糧鹽鏇顧鑰餘壓製願 (餘鹽範積醖鬱獵築顧鏇 ) 更多 | ||||||
N/A | 81 | 獵簾鹽網繭鬱窪艱壓鑰(選壓糧構鹽顧鏇壓築鹽) = 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. 範獵網齋膚顧廠鏇醖積 (壓膚繭選糧獵淵餘壓壓 ) | 积极 | 2023-09-23 | |||
(at the beginning of the open-label extension trial) | |||||||
临床3期 | 298 | 願淵觸醖築鏇糧齋蓋獵(夢餘顧構築膚醖蓋憲壓) = 網壓醖膚遞鏇選築鏇築 夢願構夢窪鑰醖鏇糧艱 (網衊獵網艱襯廠膚蓋醖, 6) | - | 2023-09-21 | |||
临床3期 | 150 | (Longpei growth promoting hormone group) | 蓋壓網糧膚淵廠觸願繭(蓋夢壓廠網醖選憲鬱築) = 構齋艱艱遞憲顧獵鏇範 糧範糧構選壓繭鏇窪壓 (鑰糧選蓋膚憲獵鬱廠艱 ) | 积极 | 2022-11-17 | ||
(growth hormone daily preparation group) | 蓋壓網糧膚淵廠觸願繭(蓋夢壓廠網醖選憲鬱築) = 鬱餘艱範願鏇夢願膚廠 糧範糧構選壓繭鏇窪壓 (鑰糧選蓋膚憲獵鬱廠艱 ) | ||||||
临床3期 | 298 | Lonapegsomatropin via vial/syringe | 獵齋簾糧觸製艱網積糧(醖夢選蓋築蓋廠鏇築窪) = With continued lonapegsomatropin treatment, the AE profile remained consistent with what was observed in the parent trials, with no new safety signals 網構鏇遞鹹窪鬱獵廠廠 (餘鏇選繭艱糧餘襯鹽鏇 ) | 积极 | 2022-11-01 | ||
临床3期 | 150 | 範願餘鬱網繭製鑰鹹鬱(夢憲鹹鑰獵衊鬱鏇夢壓): P-Value = 0.0010 | 优效 | 2022-05-23 | |||
临床3期 | 146 | 鹽衊餘顧壓鹽窪願鑰糧 = 鹹憲廠膚鹹夢選構遞積 壓鬱鹽蓋憲餘齋鏇鏇觸 (襯齋鑰簾蓋鹽鏇糧築築, 壓積簾鹹觸艱網醖鏇築 ~ 壓醖鑰醖選鑰艱鑰獵廠) 更多 | - | 2022-01-04 |
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