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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

PubMedGrowth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society2026-11-03

Once-weekly somatrogon versus daily somatropin in pediatric growth hormone deficiency: A systematic review and meta-analysis.

Al-Enezi Rowa T RT, Alkhaldi Kawthar K KK, Almuhannadi Fahad N FN, Aljassar Anwar M AM et al.

Pediatric growth hormone (GH) deficiency is treated with daily somatropin injections, which may reduce adherence over long treatment periods. Somatrogon is a once-weekly long-acting GH designed to reduce treatment burden while maintaining efficacy and safety. This systematic review and meta-analysis compared once-weekly somatrogon with once-daily somatropin in children with GH deficiency. We searched PubMed, Scopus, and Web of Science from inception to April 2026 for randomized controlled trials (RCTs) and comparative studies of prepubertal children with GH deficiency. Outcomes were IGF-1 standardized score (SDS), change from baseline in height SDS, height velocity, and adverse events. Random-effects meta-analysis was performed, with subgroup analyses by follow-up duration and sensitivity analyses to assess robustness using R software. A total of seven studies, including three RCTs, two retrospective real-world cohorts, and two post hoc analyses were included. Compared with daily somatropin, weekly somatrogon produced a significantly greater increase in IGF-1 SDS at 3, 6, 9, and 12 months, with a consistent effect across time points. The change from baseline in height SDS did not differ significantly between groups at any follow-up point. Height velocity was generally comparable, although a transient advantage for somatrogon was observed at 9 months. The rate of any adverse event was slightly lower in somatropin group, but did not reach statistical significance. Once-weekly somatrogon is an effective and relatively safe alternative to daily somatropin in prepubertal children with GH deficiency, with the practical advantage of reduced injection frequency and potentially lower treatment burden.

PMID 42976408
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PubMedThe Journal of clinical endocrinology and metabolism2026-10-26

Efficacy and Safety of Lonapegsomatropin in Children With Turner Syndrome: 52-Week Results From the New InsiGHTS Trial.

Davis Shanlee M SM, Abuzzahab M Jennifer MJ, Tryggestad Jeanie B JB, Fechner Patricia Y PY et al.

Treatment with growth hormone is effective in improving height outcomes in children with Turner syndrome. However, poor adherence-often influenced by daily injection burden-may compromise treatment outcomes. Lonapegsomatropin is a prodrug, administered once weekly, that provides sustained release of somatropin. To evaluate the efficacy and safety of lonapegsomatropin in children with Turner syndrome. New InsiGHTS is a phase 2 dose-ranging trial (ClinicalTrials.gov: NCT05690386). This trial was conducted across 19 centers in the United States. This trial enrolled and dosed 49 prepubertal children with Turner syndrome. Randomization was 1:1:1:1 to receive once-weekly lonapegsomatropin (0.24, 0.30, or 0.36 mg hGH/kg/week) or daily somatropin (0.35 mg/kg/week). The primary efficacy endpoint was annualized height velocity (AHV) at week 26. Secondary efficacy endpoints included AHV at week 52 and change from baseline in height standard deviation score (SDS) at weeks 26 and 52. At week 26, AHV was comparable between lonapegsomatropin starting dose cohorts (range: 9.23 to 10.36 cm/year) and the somatropin cohort (10.86 cm/year). At week 52, AHV was comparable between pooled lonapegsomatropin cohorts (9.05 cm/year) and the somatropin cohort (9.04 cm/year), with mean gains in height SDS of 0.60 and 0.67, respectively. Lonapegsomatropin was well tolerated with a safety profile similar to somatropin. Across evaluated doses, lonapegsomatropin treatment demonstrated comparable efficacy, safety, and tolerability to somatropin after 1 year, supporting development of lonapegsomatropin as a once-weekly treatment option for short stature in children with Turner syndrome.

PMID 42929032
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PubMedAnnals of pediatric endocrinology & metabolism2026-10-11

Somatrogon versus somatropin in children with growth hormone deficiency: a real-world matched-cohort study.

Orman Burçe B, Kücükali Gülin Karacan GK, Keskin Melikşah M, Erdeve Şenay Savaş ŞS

Somatrogon is a once-weekly growth hormone (GH) analog approved for GH deficiency (GHD), but real-world head-to-head data are limited. Using a matched-cohort design with a protocol-defined IGF-1 sampling time, we compared first-year growth outcomes and safety of somatrogon and daily somatropin in children with GHD. We conducted a retrospective matched-cohort study in 30 children with GHD (15 per group) at a single center. Groups were matched by age (±1 year), sex, and pubertal stage. Annual height velocity (AHV), height standard deviation score (SDS) gain, insulin-like growth factor 1 (IGF-1) SDS, insulin-like growth factor binding protein 3 (IGFBP-3), bone age advancement, and metabolic parameters were assessed at 12 months. AHV was similar in both groups (8.96±1.67 vs 8.84±1.57 cm/year; p=0.841). Height SDS gain did not differ (0.60±0.36 vs 0.53±0.33; p=0.569). IGF-1 SDS was numerically higher in the somatrogon group (+0.59 vs -0.14; p=0.132) but remained within safe limits in all patients. Bone age advancement, glucose, and insulin levels were similar between groups. No adverse events or injection-site reactions were documented during follow-up. In this matched cohort, no significant differences in growth or safety outcomes were observed between somatrogon and somatropin at one year. Somatrogon appears to be a reasonable alternative to daily GH therapy in children with GHD.

PMID 42860242
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PubMedJournal of the Endocrine Society2026-10-11

Up to 5 years of weekly somatrogon in children with growth hormone deficiency: final data from the global phase 3 study.

Stawerska Renata R, Deal Cheri L CL, La Torre Daria D, Taylor Carrie T CT et al.

This open-label extension (OLE) study aimed to evaluate the long-term efficacy and safety of once-weekly somatrogon in pediatric patients with growth hormone deficiency (GHD) following up to 5 years of somatrogon treatment. Patients who had previously completed 12 months of treatment (somatrogon or somatropin) in a phase 3, randomized, active-controlled study (NCT02968004) were eligible to enroll into this OLE study; somatropin-treated patients were switched to somatrogon (0.66 mg/kg/week), and somatrogon-treated patients received somatrogon at their previous dose. A total of 212 patients entered the OLE. Mean annualized height velocity at the end of OLE Year 1 (Y1), Y2, Y3, and Y4 was 8.11, 7.91, 7.02, and 6.56 cm/year, respectively. Mean height SDS increased in each year of the OLE and approached 0 SDS by OLE Y4. Mean (SD) IGF-I SDS was positive and within the normal range throughout the OLE. The incidence of adverse events (AEs) was 53.8% to 72.3%, with most being mild to moderate. The incidence of serious AEs in each year was low (0-4.7%), and none were related to treatment. The most common treatment-related AEs were injection-site pain and injection-site erythema. The presence of antidrug antibodies did not appear to impact safety or efficacy outcomes. Based on the final data from the largest cohort of somatrogon-treated patients to date, once-weekly somatrogon demonstrated sustained efficacy and an acceptable safety profile during the OLE period. Once-weekly somatrogon constitutes a valuable long-term alternative to once-daily somatropin, offering potentially improved adherence and treatment outcomes.

PMID 42856902
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PubMedEndocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists2026-10-09

Long-Term Safety and Efficacy of Once-Weekly Lonapegsomatropin in Adults With Growth Hormone Deficiency: Results From a 52-Week Open-Label Extension Trial.

Biller Beverly M K BMK, Gilis-Januszewska Aleksandra A, Doknic Mirjana M, Picó Antonio Miguel AM et al.

To evaluate the long-term safety and efficacy of once-weekly lonapegsomatropin in adults with growth hormone (GH) deficiency. This 52-week, multicenter, open-label extension trial enrolled adults with GH deficiency who completed the 38-week phase 3 foresiGHt trial, in which participants received lonapegsomatropin, placebo, or somatropin. In the extension, all participants received lonapegsomatropin. Safety assessment included adverse events, laboratory values, vital signs, immunogenicity, 12-lead electrocardiograms, and fundoscopy. Body composition (trunk percent fat, trunk fat mass, visceral adipose tissue, total body lean mass, trunk lean mass, and appendicular lean mass) was measured by dual-energy x-ray absorptiometry, and patient-reported outcomes were evaluated. After foresiGHt completion, 220 (88.7%) participants enrolled in the extension. Across foresiGHt and the extension, common lonapegsomatropin-associated adverse events were nasopharyngitis, upper respiratory infection, and headache. Injection-site reactions were infrequent (5.1%) and mild or moderate. After up to 90 weeks of treatment, body composition was maintained in participants continuing lonapegsomatropin and improved relative to foresiGHt baseline in those initiating or switching to lonapegsomatropin. Clinically meaningful improvements in patient-reported outcomes from foresiGHt baseline were observed; 43.5%, 40.6%, and 35.8% of participants achieved a ≥10-point improvement in the Treatment-Related Impact Measure-Adult GH Deficiency total score among those continuing, initiating, or switching to lonapegsomatropin, respectively. Once-weekly lonapegsomatropin was generally well tolerated and was associated with sustained improvements in body composition and patient-reported outcomes for up to 90 weeks. These findings extend prior evidence and support the long-term benefits of lonapegsomatropin in adults with GH deficiency, including those switching from somatropin.

PMID 42855131
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PubMedThe AAPS journal2026-09-22

Immunogenicity Profile of Lonapegsomatropin During Long-Term Treatment in Children With Growth Hormone Deficiency.

Mygind Per Holse PH, Weiser Amiee A, Fürst Camilla Melin CM, Komirenko Allison S AS et al.

Monitoring and evaluation of immunogenicity is important for biological therapeutics due to the potential impact of antibodies on safety and efficacy. A comprehensive immunogenicity assessment was conducted to support clinical development of lonapegsomatropin, a prodrug of somatropin, administered once weekly. Lonapegsomatropin is approved in the United States for pediatric and adult growth hormone deficiency (GHD), and in other countries for pediatric GHD. Lonapegsomatropin consists of somatropin, an inert methoxy polyethylene glycol carrier (mPEG), and a proprietary TransCon® linker that transiently binds somatropin to the carrier. Four dedicated immunoassays were developed, validated, and applied in a risk-based tiered approach to rigorously assess the immunogenicity of lonapegsomatropin in children with GHD. Samples collected from 298 children with GHD treated with lonapegsomatropin for up to six years were analyzed for anti-drug antibodies (ADAs) against lonapegsomatropin (intact prodrug), released somatropin, and mPEG. Treatment-emergent anti-lonapegsomatropin, anti-somatropin, and anti-mPEG binding antibodies were detected in 4.7%, 5.4%, and 0.7% of treated children, respectively. ADA responses were low titer, transiently detected, and primarily observed within the first year of treatment, and no neutralizing antibodies were detected. These findings support the long-term low immunogenicity of lonapegsomatropin in children with GHD, consistent with somatropin. Importantly, the multi-assay tiered strategy applied here was robust and reproducible, enabling sensitive detection of ADAs against the intact prodrug, mPEG, and released somatropin across trials, and demonstrated its clinical applicability for evaluating a complex long-acting growth hormone like lonapegsomatropin.

PMID 42768234
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