Sogroya (somapacitan) / Novo Nordisk - LARVOL DELTA

Long-Acting Growth Hormone for Pediatric Growth Hormone Deficiency. (PubMed, J Endocr Soc) - "Five trials were eligible for inclusion in a Bayesian network meta-analysis; 3 contributed to the base case network, including 3 LAGHs (lonapegsomatropin, somapacitan, and somatrogon) and daily somatropin. In this network meta-analysis, lonapegsomatropin was the only LAGH associated with better growth outcomes. No significant differences were detected regarding SAEs; other safety outcomes could not be analyzed."

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

Long-acting growth hormone in the treatment of children with growth hormone deficiency. (PubMed, Expert Rev Endocrinol Metab) - "The review focuses on the LAGH approved from both the Food and Drug Administration (FDA) and European Medicines Agency (EMA) for the treatment of pediatric growth hormone deficiency (PGHD): Lonapegsomatropin, Somatrogon and Somapacitan. Even if current evidence suggests a non-inferiority of all the three LAGH formulations when compared to daily rhGH, long-term concerns persist regarding the non-physiological GH profile associated with LAGH, characterized by weekly instead of daily peaks. Further research and real-life studies are required to better define the long-term efficacy of these formulations."

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

Long-term efficacy and safety of once-weekly somapacitan in children with growth hormone deficiency: 7-year results from the randomised REAL 3 trial (ESPE-ESE 2025) - No abstract available

Clinical • Endocrine Disorders • Growth Hormone Deficiency

MySoConnect® for Sogroya®: long-acting growth hormone for patients with growth-related disorders and their caregivers (ESPE-ESE 2025) - No abstract available

Clinical

Long-term efficacy and safety of once-weekly somapacitan in children with growth hormone deficiency: 7-year results from the randomised REAL 3 trial (ESPE-ESE 2025) - No abstract available

Clinical • Endocrine Disorders • Growth Hormone Deficiency

Weekly Somapacitan is Effective and Well-Tolerated in Children with Idiopathic Short Stature: a Randomised Phase 3 Trial (ESPE-ESE 2025) - No abstract available

Clinical • Late-breaking abstract • P3 data • Idiopathic Short Stature

Once-weekly Somapacitan in GHD: 7 Years Data from REAL 3 (ESPE-ESE 2025) - "Sponsored by Novo Nordisk sponsored satellite symposium."

Efficacy of somapacitan in treatment-fatigue adults with growth hormone deficiency previously treated with daily GH injections: a 24-week randomized active-controlled trial (ESPE-ESE 2025) - No abstract available

Clinical • Endocrine Disorders • Fatigue • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult)

Patient Journey with Somapacitan in GHD (ESPE-ESE 2025) - "Sponsored by Novo Nordisk sponsored satellite symposium."

Clinical

Efficacy and safety of somapacitan versus daily growth hormone at 52 weeks in patients with growth hormone deficiency: pooled analysis of the randomised REAL 3, REAL 4 and REAL 6 clinical trials (ESPE-ESE 2025) - No abstract available

Retrospective data • Endocrine Disorders • Growth Hormone Deficiency

Weekly Somapacitan is Effective and Well-Tolerated in Children Born Small for Gestational Age: Randomised Phase 3 Trial (ESPE-ESE 2025) - No abstract available

Clinical • Late-breaking abstract • P3 data • Small for Gestational Age

Efficacy of somapacitan in treatment-fatigue adult patients with growth hormone deficiency previously treated with once-daily growth hormone injections: a 24-week randomized active-controlled trial. (PubMed, Endocr Pract) - "In AGHD patients who were fatigued from the long-term daily GH injections, somapacitan was reported to be more convenient than daily GH. It was effective in maintaining IGF-1 levels and body composition, glucose, lipids, and vascular parameters, comparable to daily GH. Non-significant decrease in BMD with somapacitan could reflect a favorable increase in bone metabolic units, as previously observed in naïve patients with GHD during the initial 6-month period of GH therapy."

Journal • Endocrine Disorders • Fatigue • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • IGF1

Growth Response to Weekly Somapacitan Therapy in Children With GH Deficiency Is Related to GH Thresholds in GH Stimulation Testing. (PubMed, J Endocr Soc) - "Mean change in IGF-I SDS ranged from 3.13 to 3.01, 2.11 to 1.96, and 1.87 to 2.26 at week 52 and from 2.81 to 2.11, 1.85 to 1.62, and 1.28 to 1.71 at week 104 for the 3 GH peak concentrations. Patients with GHD in the ≤3 μg/L GH peak concentration group had greater HV and greater changes in height SDS and IGF-I SDS from baseline."

Journal • Endocrine Disorders • Growth Hormone Deficiency • IGF1

Safety and efficacy of weekly somapacitan for growth hormone deficiency in children: A 72-week observational study. (PubMed, Saudi Med J) - "Weekly somapacitan offers an effective, safe pediatric GHD treatment, with individualized dosing based on IGF-1 levels. Routine IGF-1 monitoring is advised to maximize benefits and minimize risks. Further studies on diverse populations are recommended to validate these findings in pediatric endocrinology."

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

Efficacy in Japanese adults with growth hormone deficiency receiving weekly somapacitan or daily growth hormone: results from phase 3 REAL 1 trial. (PubMed, Front Endocrinol (Lausanne)) - P3 | "Participants received once-weekly somapacitan or daily GH (Norditropin®), both administered subcutaneously. Somapacitan provides an effective alternative to daily GH in AGHD. http://www.clinicaltrials.gov, identifier NCT02229851."

Clinical • Journal • P3 data • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult)

New reimbursed medicines in 2025. The updated list brings essential treatments [Google translation] (Capital) - "Following a proposal made by the Ministry of Health in September 2024, the Economic and Social Council (CES) recently approved a new addition to the list of reimbursed medicines...For outpatient treatments, reimbursed at a rate of 90%, Somapacitan will be introduced , a drug used for growth hormone substitution in children and adults with growth hormone deficiency...Regarding fully compensated (100%) treatments...Fenfluramine – indicated for the treatment of epilepsy....Carglumic acid – prescribed to patients with hyperammonemia caused by metabolic diseases; Finerenone – intended for the treatment of chronic kidney disease in the predialysis phase."

Reimbursement • Chronic Kidney Disease • Epilepsy • Growth Hormone Deficiency • Metabolic Disorders

A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9 (clinicaltrials.gov) - P3 | N=48 | Active, not recruiting | Sponsor: Novo Nordisk A/S | Recruiting ➔ Active, not recruiting

Enrollment closed • Pan tumor • Genetic Disorders • Idiopathic Short Stature • Pediatrics • Small for Gestational Age • Turners Syndrome

REAL 8: A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow (clinicaltrials.gov) - P3 | N=399 | Active, not recruiting | Sponsor: Novo Nordisk A/S | Recruiting ➔ Active, not recruiting

Enrollment closed • Pan tumor • Genetic Disorders • Idiopathic Short Stature • Small for Gestational Age • Turners Syndrome • IGF1

A Study to Follow Paediatric Participants With Growth Hormone Deficiency Treated With Somapacitan for Long Term Safety Information and Clinical Parameters (clinicaltrials.gov) - P=N/A | N=500 | Enrolling by invitation | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Diabetes • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Metabolic Disorders • Oncology • Pediatrics • Type 2 Diabetes Mellitus

Growth Hormone for the Treatment of Gastroparesis (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Mayo Clinic

New P1 trial • Gastrointestinal Disorder

Long-acting growth hormones: innovations in treatment and guidance on patient selection in pediatric growth hormone deficiency. (PubMed, Ann Pediatr Endocrinol Metab) - "In contrast, LAGHs, such as somatrogon, somapacitan, and lonapegsomatropin, are designed for once-weekly administration, improving patient compliance and quality of life. Pediatric endocrinologists must carefully consider which patient groups would benefit most from this therapy, particularly those at risk for poor adherence to daily injections, such as patients undergoing multi-drug therapy, patients with needle phobia or behavioral disorders, very young children, adolescents, patients with separated parents, families that travel frequently, or children involved in activities like scouting. LAGHs present an opportunity to enhance therapeutic outcomes and adherence, but careful patient selection remains critical to maximizing their potential benefits."

Journal • Behavior Disorders • Endocrine Disorders • Genetic Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Lipodystrophy • Mental Retardation • Pain • Pediatrics • Psychiatry

Current understanding and perspectives on growth and long-acting GH therapy in Japan. (PubMed, Clin Pediatr Endocrinol) - "In Japan, somatrogon and somapacitan are available, and lonapegsomatropin has completed a clinical trial. Well-designed clinical research is needed to expand the indications for LAGH to other conditions, such as idiopathic short stature. Finally, future research on orally administered agents may open new avenues for the treatment of short stature."

Journal • Review • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Idiopathic Short Stature • Pediatrics

Identification and differentiation of somapacitan, a long-acting growth hormone derivative, and recombinant human growth hormone in equine plasma by LC-HRMS for doping control purpose. (PubMed, Growth Horm IGF Res) - "Furthermore, using the peptide fragments T1, T8, and T9 (which are shared between somapacitan and rhGH), the presence of somapacitan in equine plasma could be confirmed with higher sensitivity, achieving down to LOIs of 2 ng/mL and LODs of 1 ng/mL. The method was validated with respect to specificity, identification capability, robustness, precision, and reproducibility, paving the way for the analysis of post-administration samples from our already planned administration trials and future potential positive cases."

Journal • Endocrine Disorders • Growth Hormone Deficiency

A Study to Follow Paediatric Participants With Growth Hormone Deficiency Treated With Somapacitan for Long Term Safety Information and Clinical Parameters (clinicaltrials.gov) - P=N/A | N=500 | Not yet recruiting | Sponsor: Novo Nordisk A/S

New trial • Diabetes • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Metabolic Disorders • Oncology • Pediatrics • Type 2 Diabetes Mellitus

Somapacitan is Effective and Well Tolerated in Chinese Children with GHD: 52-week Results from the Randomized Phase 3 REAL6 Trial (ESPE 2024) - P3 | "In conclusion, once-weekly somapacitan (0.16mg/kg/week) has a similar efficacy and safety profile as daily GH (0.034mg/kg/ day) and display a similar mean IGF-I SDS in treatment-naïve Chinese children with GHD. These results closely mirror findings for the efficacy and safety of somapacitan compared to daily GH observed during the global phase 3 REAL4 study."

Clinical • P3 data • Growth Hormone Deficiency • Growth Hormone Deficiency (Adult) • Pain • IGF1