Drug Database
SO

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

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
Read full article →
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
Read full article →
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
Read full article →
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
Read full article →
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
Read full article →
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
Read full article →

+375 more articles available with a free account

Sign up free to view all articles →

Ask about somatropin