Ngenla (somatrogon-ghla) / OPKO Health, Pfizer - LARVOL DELTA

Transition to once-weekly growth hormone in paediatric isolated growth hormone deficiency: A real-world experience. (PubMed, Eur J Endocrinol) - "Transition from daily growth hormone to once-weekly somatrogon maintained effective growth outcomes in paediatric patients with isolated GHD. These findings support the effectiveness of weekly therapy in routine clinical practice. Further long-term studies are needed to better characterize metabolic effects and inform individualized treatment strategies."

Journal • Real-world evidence • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Pediatrics • IGF1

Treatment of growth hormone deficiency with long-acting growth hormones in children, adolescents and adults: Clinical evidence and practical considerations. (PubMed, Ann Endocrinol (Paris)) - "Three once-weekly LAGH products are currently available in the EU: lonapegsomatropin, somatrogon and somapacitan. With a focus on somapacitan, currently the only LAGH approved in France for both children and adults, the review discusses practical aspects of dosing and monitoring across age groups and addresses use in special populations and during the transition period from paediatric to adult care. Ongoing follow-up and real-world studies will further clarify long-term safety, adherence and metabolic outcomes."

Journal • Review • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • Growth Hormone Deficiency (Pediatric) • Pediatrics

Injection-site pain after switching from somatrogon to somapacitan in children reporting pain or discomfort during once-weekly growth hormone therapy: a prospective single-arm switch study. (PubMed, Front Endocrinol (Lausanne)) - "In children who reported injection-site pain or discomfort during somatrogon therapy and agreed to switch, pain scores and treatment preference improved after switching to somapacitan. These findings support considering a switch to another once-weekly GH formulation when injection-site pain affects treatment preference."

Journal • Brain Cancer • CNS Tumor • Endocrine Disorders • Growth Hormone Deficiency • Pain

MISSION, A MULTICENTER INTERVENTIONAL STUDY: SOMATROGON IMPACT ON OUTCOMES IN NAIVE SMALL FOR GESTATIONAL AGE OR IDIOPATHIC SHORT STATURE PAEDIATRIC PATIENTS COMPARED WITH DAILY GROWTH HORMONE (ESPE 2026) - No abstract available

Clinical • Idiopathic Short Stature • Pediatrics • Small for Gestational Age

Real‑world growth and metabolic outcomes of once‑weekly somatrogon in children with growth hormone deficiency. (ESPE 2026) - No abstract available

Clinical • Real-world • Real-world evidence • Endocrine Disorders • Growth Hormone Deficiency

PROGRES 2.0, a non-interventional, observational cohort study of patients receiving weekly somatrogon or daily growth hormone (Genotropin®) as part of routine clinical care (ESPE 2026) - No abstract available

Clinical • Observational data

Somatrogon in growth hormone deficiency: 30-month real-world outcomes (ESPE 2026) - No abstract available

Clinical • Real-world • Real-world evidence • Endocrine Disorders • Growth Hormone Deficiency

Once-Weekly Somatrogon in Real-World Clinical Practice: Pediatric Endocrinologists' Perspectives (ESPE 2026) - No abstract available

Clinical • Real-world • Real-world evidence • Pediatrics

Usability, safety and caregiver satisfaction of once-weekly somatrogon in Bulgaria (ESPE 2026) - No abstract available

Clinical

Weekly somatrogon vs daily somatropin: a propensity score-matched analysis of growth outcomes from clinical data vs KIGS. (PubMed, J Endocr Soc) - P3 | "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."

Clinical data • Journal • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Pediatrics

Long-Acting Growth Hormone Versus Daily Growth Hormone for Growth Hormone Deficiency Patients: A Network Meta-Analysis of Clinical Trials. (PubMed, Endocrinol Diabetes Metab) - "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."

Clinical • Journal • Retrospective data • Review • Dermatology • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Pain • Pediatrics • IGF1

Influence of long-acting growth hormone analogs on other hypothalamic-pituitary axes: a real-world study. (PubMed, J Endocrinol Invest) - "In isolated GHD, adrenal and thyroid function remained stable after LAGH initiation, with comparable results in treatment‑naïve patients and in those already receiving daily therapy. A greater increase in IGF-I levels was observed in switchers, suggesting that a lower starting dose may be appropriate in patients previously treated with rhGH. Further studies are required to clarify the endocrine effects of long‑acting formulations in individuals with associated multiple pituitary hormone deficiencies."

Journal • Real-world evidence • Endocrine Disorders • Growth Hormone Deficiency • IGF1

Real-World Clinical Experience with Weekly Somatrogon in Pediatric Growth Hormone Deficiency: a French longitudinal study with some unexpected clinical observations. (PubMed, Ann Endocrinol (Paris)) - "Somatrogon was as effective as dGH on growth but was associated with rapid BMI catch-up and a high discontinuation rate in patients transitioning from dGH. Clinical management should prioritize nutritional monitoring and rigorous education on injection site rotation to limit the BMI increase and local adverse effects. Further longitudinal studies are essential to evaluate potential metabolic changes and assess body composition using standardized methods, as BMI alone lacks sufficient sensitivity."

Journal • Observational data • Real-world evidence • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Lipodystrophy • Pain • Pediatrics • IGF1

Open-Label 9-Year Follow-Up Extension Phase 2 Study of Once-Weekly Somatrogon in Children With Growth Hormone Deficiency. (PubMed, J Clin Endocrinol Metab) - P2 | "Once-weekly somatrogon is a well-tolerated and a viable long-term treatment for GHD in children. More real-world data are needed. Clinicaltrials.gov: NCT01592500."

Journal • P2 data • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Pediatrics

RCRC000035: Comparison of weekly Somatrogon to daily Genotropin in children born small for gestational age or with idiopathic short stature. (clinicaltrialsregister.eu) - P2/3 | N=42 | Not yet recruiting | Sponsor: Schneider Children's Medical Center Of Israel

New P2/3 trial • Idiopathic Short Stature • Pediatrics • Small for Gestational Age

Comparison of efficacy and safety between long-acting growth hormone and short-acting growth hormone in isolated growth hormone deficiency: a systematic review and meta-analysis of 16 randomized controlled trials involving 2,435 pediatric patients. (PubMed, Front Pediatr) - "Subgroup analyses were performed based on LAGH platform (PEG-LAGH, somatrogon, somapacitan, lonapegsomatropin) and treatment duration. Among children with isolated GHD, LAGH represents the preferred platform, offering both superior first-year height velocity and acceptable safety. In contrast, newer prodrug or albumin-binding LAGH formulations provide injection convenience but lack superior growth efficacy."

Journal • Retrospective data • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Pediatrics • IGF1

Real world performance of once weekly somatrogon on naive patients with isolated growth hormone deficiency: Mind the weight gain. (PubMed, Growth Horm IGF Res) - "Somatrogon was effective and well tolerated in treatment-naïve children with GHD, providing sustained growth improvement and a potential advantage for adherence due to reduced injection frequency. However, increased body weight gain shown in the weekly GH group raises concerns and needs further confirmation and justification."

Journal • Real-world evidence • Endocrine Disorders • Growth Hormone Deficiency • IGF1

Pharmacovigilance Evaluation of Somatrogon-Associated Adverse Events in Real-World Databases. (PubMed, Endocr Connect) - "Among 168 FAERS cases with valid onset data, 79.76% occurred within 30 days, with a median onset of 0 days. Somatrogon's real-world AE pattern shows early-onset injection-site reactions, device-related issues, and endocrine signals, highlighting the need for early treatment monitoring and ongoing post-marketing surveillance as its use grows globally."

Adverse events • Journal • Real-world evidence • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Pediatrics

Once-Weekly Somatrogon in Pediatric Growth Hormone Deficiency: Real-World Efficacy, Safety, and Quality-of-Life Findings (ENDO 2026) - "Once-weekly somatrogon demonstrated efficacy and safety comparable to daily somatropin with stable quality of life and psychosocial outcomes in children with GHD."

Clinical • HEOR • Real-world • Real-world effectiveness • Real-world evidence • CNS Disorders • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Mental Retardation • Pediatrics • IGF1

Injection-Site Pain with Two Once-Weekly Growth Hormone Products in Children: A Sequential within-Subject Comparison of Somatrogon and Somapacitan (ENDO 2026) - "In pediatric patients experiencing injection-site pain with somatrogon, switching to somapacitan resulted in significant pain reduction in a within-subject comparison. These findings support the clinical importance of formulation choice and may facilitate shared decision-making in pediatric growth hormone therapy."

Clinical • Brain Cancer • CNS Tumor • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Pain

Production and Characterization of OPK8801001, a Novel Long Acting hGH Antagonist for the Treatment of Acromegaly (ENDO 2026) - "Background: OPKO Biologics develops biobetter long acting therapeutic proteins, including NgenlaTM, an approved long acting human growth hormone (hGH)...The global market for acromegaly therapies is estimated at USD 2.5–3.0 billion annually, of which approximately USD 300 million is attributable to Somavert... OPK8801001 is a highly potent long acting hGH antagonist with favorable pharmaceutical properties and sustained efficacy across nonclinical species, supporting its potential as a once weekly alternative to daily acromegaly therapy with an estimated weekly dose of 30-80 mg, anticipated to normalize the IGF-1 levels"

Late-breaking abstract • Acromegaly • Endocrine Disorders • IGF1

Mapping the Evidence on Once-Weekly Somatrogon Versus Daily Somatropin in Prepubertal Children with Growth Hormone Deficiency: A Systematic Review (ENDO 2026) - "Weekly dosing was consistently associated with high adherence and lower perceived treatment burden. Conclusion Once-weekly somatrogon demonstrates comparable efficacy and safety to daily somatropin in prepubertal children with GHD and may offer meaningful advantages by reducing injection frequency and treatment burden."

Clinical • Review • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • IGF1

Extension of the Phase 3 Trial of Somatrogon in Children with Growth Hormone Deficiency: 3 Years of Safety and Efficacy. (PubMed, Horm Res Paediatr) - P3 | "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."

Journal • P3 data • Dermatology • Endocrine Disorders • Growth Hormone Deficiency • Pain • IGF1

Is Somatrogon different? 6-month clinical outcomes and follow-up data in Turkish children transitioned from Somatropin to Somatrogon. (PubMed, Growth Horm IGF Res) - "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."

Clinical data • Journal • Review • Endocrine Disorders • Growth Hormone Deficiency • IGF1

The efficacy and safety of weekly somatrogon treatment in turkish children with growth hormone deficiency: a real-world cohort study. (PubMed, Endocrine) - "Based on our real-world data, weekly somatrogon therapy provided an effective growth response and was well tolerated in pediatric patients with GHD. In most cases, mean IGF-1 levels remained within the normal range. However, IGF-1 levels may be elevated, particularly in pubertal patients. These findings support somatrogon as a safe and effective early treatment option in routine clinical practice, although larger and longer-term studies are required to confirm long-term safety."

Journal • Real-world evidence • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Pediatrics • IGF1