若生智能
Drug Database
SO

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

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
阅读全文 →
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
阅读全文 →
PubMedFrontiers in surgery2026-07-17

Anterior cervical osteophyte-related dysphagia in a long-term growth hormone user: a case report.

Perez Sui-Ling SL, Martinez Lynette L, Rosselli Michael M, Nair Rakesh Ravikumaran RR

Anterior cervical osteophytes can compress the esophagus, producing dysphagia. Although common on imaging in older adults, symptomatic osteophytic dysphagia is underdiagnosed, and the role of systemic anabolic factors in osteophyte growth is poorly characterized. A 62-year-old male ex-military recreational bodybuilder presented with cervicalgia and left shoulder pain. Cervical radiographs and MRI demonstrated multilevel degenerative changes including a prominent anterior osteophyte at C3-C4 with esophageal compression. On directed questioning, he reported intermittent dysphagia with larger food boluses. He reported a cervical injury during jiu-jitsu training in 2001-2002 and disclosed approximately 20 years of patient-reported exogenous growth hormone (GH) and GH secretagogue use, including cyclical somatropin, sermorelin/GHRP-6 combination therapy, and ongoing nightly somatropin. No objective swallowing evaluation was performed given the mild, intermittent nature of symptoms. This case raises the hypothesis that chronic GH axis stimulation, in combination with remote cervical trauma, may contribute to clinically significant osteophyte formation. Conservative management was initiated with dietary modification and counseling regarding GH cessation. Clinicians should screen for dysphagia in patients with cervical spondylosis and inquire about anabolic substance use as a potentially relevant history.

PMID 42465868
阅读全文 →
PubMedGrowth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society2026-06-24

Effects of switching from somatropin to somapacitan on thyroid hormone levels in adult growth hormone deficiency: A pilot study.

Tsujimoto Yuki Y, Yamashiro Kenji K, Suzuki Yuki Y, Watanabe Yui Y et al.

Adult growth hormone deficiency (AGHD) is associated with altered body composition, reduced quality of life, and increased cardiovascular risk, which can be mitigated by growth hormone (GH) replacement. Recently, once-weekly somapacitan has been introduced as an alternative to daily somatropin, but its effects on thyroid hormones remain unclear. We retrospectively studied 22 AGHD patients switched from somatropin to somapacitan at a university hospital (2017-2023). IGF-1 and TSH showed no changes; however, FT3 and FT4 levels significantly decreased, particularly in patients receiving levothyroxine. Multiple regression identified baseline FT4, rather than levothyroxine use, as independently associated with ΔFT4. These findings suggest the need for careful monitoring of FT4 and potential adjustment of thyroid hormone replacement during somapacitan therapy.

PMID 42335808
阅读全文 →
PubMedMedical devices (Auckland, N.Z.)2026-06-08

Patient-Centric Design of the Lonapegsomatropin Auto-Injector for Growth Hormone Deficiency: Usability Validation of Safe and Effective Use.

Lau Michael M, Fabricius Paul Erik PE, Madsen Nils Berg NB, Egesborg Henrik H et al.

Treatment of pediatric growth hormone deficiency (pGHD) with daily somatropin (human growth hormone [hGH]) injections is associated with challenges including needle anxiety, which may lead to poor adherence and ultimately result in suboptimal growth outcomes. The lonapegsomatropin (TransCon hGH, SKYTROFA®) Auto-Injector, designed to deliver once-weekly lonapegsomatropin for the treatment of pGHD while minimizing injection challenges, was validated in usability studies in pGHD. The Auto-Injector was evaluated in a usability validation study conducted under simulated-use conditions in accordance with FDA guidance, involving simulated injections performed by injection-naive or injection-experienced patients with pGHD or proxy medical conditions, caregivers, and health care providers (HCPs) responsible for injections or training patients/caregivers. Half of the patient and caregiver participants received training by a Nurse Trainer. All participants (60 children, 60 caregivers, and 15 HCPs) were able to complete an injection successfully. All participants reported that they could follow the instructions as written, and 98% felt they could use the device as intended on their own or, for pediatric patients, with supervision. Use deviations observed for injection tasks for all participant groups were low: patients (3.2% of tasks), caregivers (2.4%), and HCPs (2.8%). The user-centric design of the lonapegsomatropin Auto-Injector enables successful and confident use to deliver an injection as intended, with the potential to overcome known barriers associated with GH injections and facilitate adherence, which may improve treatment outcomes.

PMID 42255032
阅读全文 →
PubMedHormone research in paediatrics2026-06-01

Extension of the Phase 3 Trial of Somatrogon in Children with Growth Hormone Deficiency: 3 Years of Safety and Efficacy.

Stawerska Renata R, Choe John J, Wang Ronnie R, Wajnrajch Michael P MP et al.

Somatrogon is a once-weekly, long-acting growth hormone approved to treat children with growth hormone deficiency (GHD). This study evaluated the long-term efficacy and safety of once-weekly somatrogon in children with GHD following up to 3 years of treatment. During the 12-month main study, patients were randomized 1:1 to once-weekly somatrogon (0.66 mg/kg/week) or once-daily somatropin (0.24 mg/kg/week). Patients could then enter an open-label extension (OLE), wherein somatrogon-treated patients continued receiving somatrogon and somatropin-treated patients switched to somatrogon (0.66 mg/kg/week). Data to the end of the second year of the OLE (OLE Year [Y] 2) are reported. Of the 222 patients who completed the main study, 212 entered OLE Y1 and 177 entered OLE Y2. Mean (SD) height velocity (HV) was 8.11 (1.84) and 7.91 (1.84) cm/y at OLE Y1 and Y2, respectively. Mean (SD) height SD score (SDS) was -1.42 (0.90) and -0.95 (0.84) in OLE Y1 and Y2, respectively. In OLE Y1 and Y2, mean change in height SDS (delta HSDS) was 1.36 and 1.61, respectively and mean insulin-like growth factor I SDS remained >1, confirming the efficacy of the treatment. Patients who switched from somatropin to somatrogon had similar HV, height SDS and delta HSDS to those who received somatrogon continuously. The incidence of adverse events (all-causality) was 71.7% and 72.3% in OLE Y1 and Y2, respectively; most were mild or moderate in severity. Injection-site pain and injection-site erythema were the most commonly reported treatment-related adverse events in the OLE period. In OLE Y1 and Y2, up to one quarter of patients had IGF-I SDS >2 at two consecutive assessments, meeting protocol criteria for dose reduction. Following up to 3 years of somatrogon treatment, children with GHD showed a persistent increase in linear growth velocity compared to baseline. Somatrogon was well tolerated, with no new safety signals identified. gov: NCT02968004.

PMID 42224388
阅读全文 →

注册免费账户还可查看另外 373 篇文献

免费注册查看全部文献 →

了解更多somatropin