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somatropin

✓ Approved

USV Limited · GHR · 多肽类

什么是 somatropin？

somatropin 是一种多肽类，由USV Limited研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)。

药物档案

公司USV Limited
药物类别多肽类
分子靶点GHR
给药途径Injectable (Others)
状态Approved
来源： ClinicalTrials.gov, USV Limited

作用机制

分子靶点

somatropin 作用于 1 个分子靶点：

GHRgrowth hormone receptor (GHBP, GHIP)
需要更深入的分析？Noah AI 可解释复杂机制并与同类药物比较。

治疗适应症

somatropin 针对 1 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Endocrine disordersGrowth hormone deficiency✓ Approved

相关研究文献

PubMedJournal of comparative effectiveness research2026-09-10

Cost-effectiveness of a connected injection device for daily somatropin therapy in pediatric growth hormone deficiency in Spain: a scenario-based microsimulation analysis using real-world data.

Arriba Antonio de A, Roeder Claudia C, Nivelle Emilia E, Dommelen Paula van PV et al.

Aim: Growth hormone deficiency (GHD) in pediatric patients is characterized by impaired growth and reduced quality of life. Recombinant human growth hormone therapy requires consistent daily administration, yet adherence remains challenging. Electronic injection devices with adherence monitoring, like Easypod®, may support more consistent administration and enable more accurate assessment of treatment response. This study evaluated the cost-effectiveness of somatropin administered via a connected injection device (EasyPod) compared with nonconnected devices in pediatric patients with GHD in Spain. Materials & methods: A microsimulation model simulated 10,000 pediatric patients aged 2-13 years and incorporated adherence-dependent growth response, treatment discontinuation, costs and utilities. Outcomes included final height, height gain, cost per cm gained and incremental cost per quality-adjusted life year gained. Scenario and sensitivity analyses assessed the impact of parameter and structural uncertainty. Results: Easypod was associated with greater height gains than nonconnected devices. Projected final height at bone maturation was 163.04 cm with Easypod versus 159.21 cm with nonconnected devices, an incremental gain of 3.83 cm. Cost per cm gained was €2625 with Easypod and €3158 with nonconnected devices, a saving of €534 per cm. The incremental cost per quality-adjusted life year gained was €27,200 within Spain's willingness-to-pay threshold. Scenario and sensitivity analyses showed consistent results. Conclusion: In this model-based analysis, Easypod was associated with improved growth outcomes and was cost-effective compared with nonconnected devices in pediatric GHD patients in Spain. Continuous adherence monitoring may support treatment optimization and more efficient healthcare resource utilization.

PMID 42720214
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PubMedEuropean journal of endocrinology2026-09-01

Long-acting growth hormone: An updated Growth Hormone Research Society consensus statement.

Schilbach Katharina K, Clayton Peter P, Agrawal Nidhi N, Arlien-Søborg Mai C MC et al.

Long-acting growth hormone (LAGH) preparations have moved from development to routine clinical use over the past decade. Several products are now approved for paediatric growth hormone deficiency (GHD), selected non-GHD short-stature indications, and, in some regions, for adult GHD. The Growth Hormone Research Society convened an international workshop in October 2025 to reappraise the evidence base and refine clinical recommendations. Currently, data are available for up to 7 years of LAGH treatment in over 8,000 individuals. This remains substantially shorter and smaller than for daily GH. Across preparations, short- to mid-term efficacy appears comparable to daily somatropin, provided dosing is individualised and monitored appropriately. Approvals and pivotal trials include both, treatment initiation and switching from daily GH, depending on product and regional label. No new major safety signals have been identified in trials and real-world reports, although data on BMI trajectories require further evaluation. Injection-site reactions remain the most frequent adverse event and vary by formulation. Anti-drug-antibodies have been observed, yet evidence suggests they have limited clinical impact. Effects on glucose metabolism resemble those of daily therapy, but metabolically high-risk groups are under-represented in studies. Among cancer survivors, data on tumour recurrence and second neoplasms with LAGH are not yet available. Recommendations and practice points emphasised careful patient selection and counselling, product-specific dosing, and insulin-like growth factor-I (IGF-I) monitoring. Urgent knowledge gaps include transition care, long-term efficacy, adherence and safety in cancer survivors. Well-resourced registries are essential for addressing these gaps and supporting safe, effective, and patient-centred use of LAGH.

PMID 42676236
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PubMedJournal of the Endocrine Society2026-08-28

Weekly somatrogon vs daily somatropin: a propensity score-matched analysis of growth outcomes from clinical data vs KIGS.

Deal Cheri L CL, Maghnie Mohamad M, Wang Ronnie R, Carlsson Martin Ove MO et al.

Somatrogon is a long-acting growth hormone utilized for treatment of pediatric patients with growth hormone deficiency (GHD). This matched cohort analysis compared the first 3 years of height outcomes for somatrogon-treated patients from a Phase 3 somatrogon study (NCT02968004) with historical data from somatropin-treated patients in the Kabi/Pfizer International Growth Study (KIGS). In the somatrogon study, patients with GHD were randomized to once-weekly somatrogon (0.66 mg/kg/week) or once-daily somatropin (0.24 mg/kg/week) for 12 months, followed by an open-label extension, during which all patients received somatrogon (0.66 mg/kg/week or lower dose as per protocol). Patients in the somatrogon study (somatrogon cohort) were matched with patients with GHD from KIGS (KIGS cohort) who had received somatropin (0.20-0.30 mg/kg/week), using propensity score matching according to baseline characteristics of geographic region, gender, age, peak GH, and height standard deviation score (HtSDS) (ie, peak GH and HtSDS at study entry). 155 patients in the somatrogon study were matched to 155 somatropin-treated patients from KIGS. The somatrogon and KIGS cohorts had similar mean annualized height velocity through Years (Y) 1 to 3 of treatment (Y1: 10.03 vs 9.57; Y2: 7.70 vs 7.33; Y3: 7.15 vs 6.56). Mean changes in HtSDS (from baseline) through Y1-3 were comparable between both cohorts, though the somatrogon cohort appeared to have larger changes in Y2-3. Somatrogon-treated patients in the Phase 3 study had similar height outcomes compared with matched somatropin-treated patients in KIGS, strengthening the expectation that once-weekly somatrogon will have comparable efficacy to somatropin in real-world treatment of pediatric patients with GHD.

PMID 42662043
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PubMedJournal of pediatric endocrinology & metabolism : JPEM2026-08-07

Pharmacogenetic hypersensitivity to somatropin in a child with severe growth hormone deficiency and MC4R p.V166I variant.

Sancak Ertugrul E, Büyükinan Muammer M, Yılmaz Ahmet Fatih AF, Karslı Berna B et al.

The melanocortin-4 receptor (MC4R) is a G protein-coupled receptor that regulates energy homeostasis. Pathogenic MC4R variants represent the most common cause of monogenic obesity and are frequently associated with increased linear growth. However, the mechanisms linking MC4R signaling to somatic growth remain incompletely understood. We report a child with severe growth hormone deficiency (GHD) carrying a heterozygous MC4R variant (c.496G>A; p.V166I), in whom recombinant human growth hormone (rhGH) therapy triggered an unexpectedly exaggerated clinical and biochemical response, suggesting a potential pharmacogenetic interaction between MC4R signaling and the GH/IGF-1 axis. The male patient was first evaluated at 1 month of age due to micropenis and diagnosed with multiple pituitary hormone deficiencies. At 57 months of age, his height was 97.3 cm (-2.56 SDS) and annual growth velocity was 4.1 cm/year (<-2 SDS); rhGH (somatropin) therapy was initiated. Despite severe biochemically confirmed GHD, rhGH at 0.03 mg/kg/day triggered an exaggerated response: IGF-1 levels increased from -3.35 SDS to +8.00 SDS. Concurrently, his height velocity accelerated to 16 cm/year, and his bone age rapidly advanced by approximately 4 years over a 23-month period, culminating in mandibular prognathism. The coexistence of severe GHD and an MC4R variant is rarely described, and such a pronounced response to rhGH has not previously been reported. These findings suggest that MC4R p.V166I may modulate peripheral GH/IGF-1 signaling and act as a pharmacogenetic modifier of GH responsiveness. Careful rhGH dose titration with close IGF-1 monitoring may be considered in patients carrying the MC4R p.V166I variant.

PMID 42562800
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PubMedEndocrinology, diabetes & metabolism2026-08-01

Long-Acting Growth Hormone Versus Daily Growth Hormone for Growth Hormone Deficiency Patients: A Network Meta-Analysis of Clinical Trials.

Abadi Amir A, Ghanem Usra U, Ghanem Hamid H, Sawafta Ahmed Jalal AJ et al.

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. 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). 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. 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.

PMID 42538635
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PubMedMedicine2026-07-18

Disproportionality analysis of sex-stratified adverse event signals in growth impairment: Insights from the FDA adverse event reporting system.

Junyu Xu X, Qian Chen C, Jingnan Xue X, Luying Qi Q et al.

This study aimed to examine sex-disaggregated adverse event signals associated with growth impairment in pediatric patients, utilizing data from the FDA adverse event reporting system, with a particular focus on growth hormone and related therapeutic agents. A disproportionality analysis was performed on FDA adverse event reporting system data spanning 2004 Q1 to 2025 Q1. The analysis encompassed 3281 growth impairment-related reports, disaggregated by gender, employing Reporting Odds Ratios (ROR) and proportional reporting ratios for signal detection, with temporal patterns assessed via Weibull distribution modeling. Significant sex-disaggregated disparities in safety signals were identified. Somatropin exhibited a stronger association with growth impairment in females (ROR 76.85, 95% CI 65.52-90.15) than in males (ROR 37.31, 95% CI 32.99-42.20). Deflazacort showed a male-exclusive signal (ROR 58.25, 95% CI 41.27-82.21), while imatinib displayed a higher risk in females (ROR 15.55, 95% CI 11.29-21.42) compared to males (ROR 4.17, 95% CI 2.91-5.99). Temporal analysis revealed an early-failure pattern, with 50.6% of events occurring within 180 days. These findings generate the hypothesis that sex-disaggregated pharmacovigilance in pediatrics, particularly for growth-modulating therapies, may reveal differential reporting patterns. Should these signals be validated in controlled prospective studies, they could inform the development of customized monitoring frameworks and dosing strategies aimed at potentially mitigating risks in hypothesized high-risk subgroups.

PMID 42470033
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