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somatropin

✓ Approved

USV Limited · GHR · Polypeptide

What is somatropin?

somatropin is a polypeptide developed by USV Limited. It is approved for therapeutic indications via injectable (others).

Drug Profile

CompanyUSV Limited
Drug ClassPolypeptide
Molecular TargetGHR
RouteInjectable (Others)
StatusApproved
Sources: ClinicalTrials.gov, USV Limited

Mechanism of Action

Molecular Targets

somatropin acts on 1 molecular target:

GHRgrowth hormone receptor (GHBP, GHIP)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

somatropin is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Endocrine disordersGrowth hormone deficiency✓ Approved

Related Research Articles

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
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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
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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
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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
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PubMedGrowth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society2026-05-27

Is Somatrogon different? 6-month clinical outcomes and follow-up data in Turkish children transitioned from Somatropin to Somatrogon.

Atas Nurgul N, Kılçık Rabia Deniz RD, Melik Fatoş Çirkin FÇ, Karaoğlan Murat M et al.

Long-acting growth hormone (GH) formulations have been developed to reduce treatment burden and improve adherence in children with growth hormone deficiency (GHD). Somatrogon is a long-acting recombinant GH analog designed for once-weekly administration and has demonstrated comparable efficacy to daily somatropin in clinical trials. However, real-world data evaluating growth outcomes after transitioning from daily GH therapy to somatrogon remain limited. This study aimed to evaluate growth outcomes, biochemical responses, and predictors of treatment response during the first six months following the transition from daily somatropin to once-weekly somatrogon. This retrospective cohort study included 121 children with confirmed GHD who had received daily somatropin therapy (35 μg/kg/day) for at least one year before switching to once-weekly somatrogon (0.66 mg/kg/week). Auxological measurements and IGF-1 levels were evaluated at baseline and at 3 and 6 months after treatment transition. Height standard deviation score (SDS) and growth velocity were compared between treatment periods. Correlation analysis was used to evaluate the relationship between IGF-1 SDS and growth response. Multivariable linear regression analysis was performed to identify predictors of growth response. The mean height gain during the final six months of somatropin therapy was 4.11 ± 2.01 cm, compared with 4.96 ± 1.56 cm during the first six months of somatrogon therapy. Height SDS increased significantly during the first three months following the transition to somatrogon compared with the final three months of somatropin therapy (0.17 ± 0.24 vs 0.08 ± 0.23; p = 0.02). However, the overall six-month change in height SDS did not differ significantly between treatment periods (p = 0.11). Mean IGF-1 SDS increased significantly from 0.12 ± 1.54 at baseline to 0.96 ± 1.96 at six months (p < 0.001). No statistically significant linear association was detected between IGF-1 SDS and height SDS improvement (r = 0.05, p = 0.62). Multivariable regression analysis identified baseline height SDS as the strongest predictor of growth response (β = -0.14, p = 0.003). Prepubertal patients showed greater height SDS improvement compared with pubertal patients (p = 0.04). Switching from daily somatropin therapy to once-weekly somatrogon showed similar short-term growth patterns over a six-month follow-up period within the limitations of a within-patient observational design in children with GHD. Growth response appeared to be influenced primarily by baseline height status and pubertal stage rather than circulating IGF-1 levels alone did not show a detectable linear association with growth response in this cohort. These findings support the use of somatrogon as an effective and practical alternative to daily GH therapy in routine clinical practice. These findings suggest that growth outcomes were maintained following treatment transition; however, results should be interpreted cautiously given the observational design.

PMID 42190542
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PubMedClinical and experimental rheumatology2026-05-19

Sex-specific risk profiles of drug-associated joint stiffness and deformity: a FAERS-based pharmacovigilance study with Canadian Vigilance Adverse Reaction Database validation.

Liu Lu L, Zhang Haoxiang H, Song Min M, Song Bangguo B et al.

Joint stiffness and joint deformity are debilitating musculoskeletal adverse drug reactions, yet their risk profiles and sex-specific differences remain poorly characterised. This study aimed to identify drug-associated safety signals and sex disparities using real-world pharmacovigilance data. Adverse event reports from the FDA Adverse Event Reporting System (FAERS; Q1 2004-Q2 2025) were analysed. Drug names and events were standardised using RxNorm and MedDRA 27.1. Disproportionality analyses (ROR) with false discovery rate correction were performed overall and by sex. External validation was conducted using the Canadian Vigilance Adverse Reaction Database (CVARDD). Weibull modelling assessed time-to-onset patterns. We identified 23,763 joint stiffness and 1,414 joint deformity reports, predominantly in females. For joint stiffness, frequently implicated drugs included methotrexate, dupilumab, and fluoroquinolones, alongside 20 newly detected signals (e.g. contrast media, ROR=217.1; gadopentetic acid, ROR=26.14). For joint deformity, alendronic acid, valproic acid, and somatropin showed strong associations, and nine novel signals were identified (e.g. vosoritide, ROR=125.78). Sex-stratified analyses revealed distinct risk profiles: females were more susceptible to bone metabolism and endocrine drugs, whereas males exhibited higher risks with enzyme replacement therapies. Time-to-onset analyses showed an early-failure pattern, with median onset as early as 63 days for methotrexate. Major signals were confirmed by the CVARDD. This study provides comprehensive real-world evidence of sex-specific differences in drug-associated joint stiffness and deformity, identifies 29 previously unreported signals, and highlights the early-onset nature of these adverse events. These findings support targeted monitoring and personalised risk management, and may inform future updates to drug safety labelling.

PMID 42154634
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