A Non-interventional, Observational, Registry-based Study to Investigate Long-term Safety and Clinical Parameters of Somapacitan Treatment in Paediatric Patients With Growth Hormone Deficiency During Routine Clinical Practice

The aim of this study is to look at the long-term safety and clinical parameters of somapacitan in paediatric participants with growth hormone deficiency under routine clinical practice conditions. The study population will include 400 paediatric growth hormone deficient participants from the Global Registry for Novel Therapies in Rare Bone and Endocrine Conditions (GloBE-Reg) treated with once-weekly somapacitan and fulfilling the eligibility criteria of the study. The total duration of the study is planned to 10 years consisting of a 5-year recruitment period in the GLoBE-Reg followed by a 5-year follow-up period.

Start Date13 Dec 2024

Sponsor / Collaborator

Novo Nordisk A/S

NCT06109935

/ Enrolling by invitationNot Applicable

A Multi-centre, Prospective, Open Label, Single-arm, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Clinical Parameters of Sogroya® Treatment in Children With Short Stature Due to Growth Hormone Deficiency Where Epiphysial Discs Are Not Closed Under Normal Clinical Practice Conditions in Japan Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due to Growth Hormone Deficiency (GHD) Where Epiphysial Discs Are Not Closed

The purpose of the study is to investigate the safety and effectiveness of Sogroya® in children with short stature due to growth hormone deficiency where epiphysial discs are not closed under real-world clinical practice in Japan. The study will last for about 1 year (at shortest) to 3 years (at longest) depending on when the participant takes part in the study. The participant will be asked to answer questionnaire(s) about how they feel about the growth hormone (GH) product treatment once during the study (at about 3 months after starting the Sogroya® treatment) and about 3 months after starting the Sogroya® treatment.

Start Date04 Oct 2023

Sponsor / Collaborator

Novo Nordisk A/S

NCT05718570

/ Enrolling by invitationNot Applicable

A Multi-national, Multi-centre, Prospective, Single-arm, Observational, Non-interventional Post-authorisation Safety Study to Investigate Long-term Safety of Sogroya® (Somapacitan) in Adults With Growth Hormone Deficiency (AGHD) Under Routine Clinical Practice

In this study, the general long-term safety and effectiveness of Sogroya (somapacitan) in adults with growth hormone deficiency (AGHD) being treated per normal clinical practice is looked into. In the study, information on side effects and how well Sogroya (somapacitan) works during long term treatment in people with Adult Growth Hormone Deficiency (AGHD) will be collected and analysed. Participants will be treated with Sogroya (somapacitan) as prescribed by the study doctor, in accordance with normal clinical practice. The study will last for 5-10 years, depending on when the participant join the study. The participant will be asked to complete two short questionnaires during every visit to the clinic. The questionnaires will collect information on the participant's well-being, work ability and ability to perform daily activities.

Start Date03 Feb 2023

Sponsor / Collaborator

Novo Nordisk A/S

100 Clinical Results associated with Somapacitan

100 Translational Medicine associated with Somapacitan

100 Patents (Medical) associated with Somapacitan

Literatures (Medical) associated with Somapacitan

30 Jun 2025·EUROPEAN JOURNAL OF ENDOCRINOLOGY

Phase 1 study and population PK/PD modeling of long-acting growth hormone, GB08, to guide pediatric dosing

Article

Author: Qin, Suofu ; Peng, Hengxin ; Lin, Yanqing ; Xu, Jiajun ; He, Wen ; Shang, Wei ; Zhu, Jiang

Abstract:

Objective:

Growth hormone deficiency (GHD) requires long-term treatment, but daily injections and adverse effects of current therapies often pose adherence challenges in children. GB08, a novel Fc-GH, leverages the extended half-life of Fc-fusion proteins to reduce injection frequency with potential for improved safety. This study evaluates the safety, immunogenicity, pharmacokinetics, and pharmacodynamics profiles of GB08 in healthy adults. The findings, along with population PK/PD modeling, will guide dosing strategies for a Phase 2 trial in pediatric GHD patients.

Design:

The study consisted of 2 parts: a randomized, double-blind, placebo-controlled single ascending dose trial and a randomized, open-label, parallel-group positive control trial.

Methods:

Subjects received a single dose of GB08 (0.16-2.4 mg/kg), 0.2 mg/kg of Jintrolong, or 7 daily doses of Norditropin (0.035 mg/kg/day). Evaluations included adverse events (AEs), immunogenicity, pharmacokinetics, and pharmacodynamics.

Results:

GB08 demonstrated a favorable safety profile with low immunogenicity, no serious AEs reported, and all AEs were mild to moderate. Pharmacokinetics and pharmacodynamics revealed dose-dependent increases, with GB08's half-life ranging from 81.7 to 110.0 h, supporting its potential for once-weekly injection. PK/PD modeling identified an optimal adult dose of 0.7 mg/kg. Further allometric scaling of adult PK data to develop a pediatric PK model suggested optimal pediatric dose of 0.8 mg/kg, balancing efficacy and safety profiles.

Conclusion:

GB08 provides notable advantages over traditional therapies, like short-acting GH, by enhancing treatment adherence and offering a potentially safer alternative. The findings from this study will guide dosing strategies for Phase 2 trial in children with GHD.

01 Jun 2025·Endocrine Practice

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

Article

Author: Janež, Andrej ; Rakusa, Matej ; Goričar, Katja ; Herman, Rok ; Jensterle, Mojca ; Klinc, Ana

OBJECTIVE:

We evaluated the efficacy of somapacitan in a 24-week, randomized, active-controlled study in patients with growth hormone deficiency (GHD) who experienced fatigue from daily growth hormone (GH) injections.

METHODS:

Twenty-nine adult patients with GHD, pretreated with daily GH for ≥5 years, who had reported treatment-related fatigue, were randomized to somapacitan or daily GH. Outcome measures were changes in treatment satisfaction assessed by Treatment Satisfaction Questionnaire for Medication-9, insulin-like growth factor-1 (IGF-1) standard deviation score, glucose and lipid parameters, body composition, bone mineral density (BMD), carotid intima media thickness, and reactive hyperaemia index, from baseline to week 24.

RESULTS:

The difference in change in Treatment Satisfaction Questionnaire for Medication-9 score for convenience was significant, in favor of somapacitan (estimated difference, somapacitan-daily GH [95% CI]:23.2 [7.9; 38.4] points, P = .004). No differences between treatment arms in estimated changes from baseline to study-end were observed for IGF-1 levels, glucose and lipid profile, visceral adipose tissue, fat mass (%), lean body mass, and vascular parameters. There was significant difference in BMD of the lumbar spine (estimated difference, somapacitan-daily GH [95% CI] -0.036 (-0.064, -0.009) gr/cm², P = .011).

CONCLUSION:

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. Nonsignificant 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.

04 May 2025·Expert Review of Endocrinology & Metabolism

Long-acting growth hormone in the treatment of children with growth hormone deficiency

Review

Author: Predieri, Barbara ; Iughetti, Lorenzo ; Lucaccioni, Laura ; Insalaco, Anna

INTRODUCTION:

The introduction of long-acting formulations in recent years is changing the landscape of growth hormone (GH) therapy. Daily recombinant human GH (rhGH) has been the treatment of choice for children and adults with GH deficiency (GHD), since its approval in 1985. However, decreasing adherence to treatment over time has been identified as a cause of the decline in rhGH efficacy, leading to significant efforts to develop long-acting rhGH (LAGH) formulations.

AREAS COVERED:

A comprehensive analysis of the literature was conducted to evaluate their mechanism of action, pharmacokinetics, pharmacodynamics, efficacy, safety profile, and administration route. 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. We aim to facilitate evidence-based clinical decisions by analyzing the available data on the three LAGH formulations.

EXPERT OPINION:

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.

News (Medical) associated with Somapacitan

13 May 2025

·www.fiercepharma.com

Novo heads to regulators after Sogroya matches predecessor Norditropin in 3 pediatric growth disorders

The FDA first approved Sogroya in August 2020 as a once-weekly treatment for adult growth hormone deficiency. The drug’s label was expanded to include children in April 2023. With a late-stage trial win for its Norditropin heir in hand, Novo Nordisk is making good on plans to boost its profile in the realm of rare disease.Over the weekend, Novo unveiled data from the phase 3 Real8 study, which found that the company’s once-weekly human growth hormone analogue Sogroya was largely on par with its daily predecessor, Norditropin, in a trio of growth disorders in kids.At the basket study’s 52-week mark, Sogroya—first approved in 2020—proved noninferior to Norditropin at improving yearly growth rate in prepubescent children with idiopathic short stature (ISS).Meanwhile, Sogroya demonstrated superiority over Novo’s daily growth hormone in children with Noonan syndrome (NS) and in children born small for gestational age (SGA) when compared to a lower Norditropin dose.When pitted against a higher dose of its growth hormone predecessor in SGA, Sogroya’s efficacy was noninferior, Novo explained in its Monday release.Sogroya was well tolerated in the study, and no new safety flags cropped up that diverged from Norditropin’s long-established profile, the company added.Sogroya’s performance in Real8 allowed the first three sub-studies to meet their primary endpoints. Leveraging data from Real8 and Real9, Novo said it has already filed for approval of Sogroya in SGA, NS and ISS with regulators in the U.S. and Europe.Novo’s Real8 program is also testing Sograya’s mettle in Turner syndrome, though those data won’t arrive until “later this year,” the company said. The FDA first approved Sogroya in August 2020 as a once-weekly treatment for adult growth hormone deficiency. The drug’s label was expanded to include children in April 2023.Sogroya is meant to succeed Novo’s once-a-day growth hormone Norditropin, which has now been on the market for decades. Eli Lilly, Merck & Co. and Pfizer all sell their own daily growth disorder drugs, while newer meds like Ascendis’ Skytrofa and Pfizer’s Ngenla are challenging Sogroya directly on the weekly-dosing front.Novo lumps sales of Norditropin and Sogroya together into its rare endocrine disorders category, which grew sales 31% in 2024 to roughly 5 billion Danish kroner ($745 million).Analytics firm GlobalData has forecast Sogroya will hit $294 million in 2030 sales and expects Norditropin to reach $960 million in sales that same year. The Sogroya results have likely bolstered Novo’s confidence in rare disease, where the company has been playing a “long endgame” since the late 2010s, Ludovic Helfgott, the company’s executive vice president of rare disease, said in a March interview with Fierce Pharma.Aside from drugs for growth disorders like Norditropin and Sogroya, Novo’s rare disease pedigree includes treatments for blood disorders like Esperoct, NovoEight or the recently approved daily hemophilia injection Alhemo, Helfgott explained.Novo plans to stick to those two major disease areas—growth and blood disorders—as it presses forward in the field.“It’s our core, and we will continue to develop this both internally and externally,” Helfgott said.

Phase 3Drug ApprovalClinical Result

12 May 2025

·pipelinereview.com

Once-weekly Sogroya® (somapacitan) is an efficacious and well-tolerated long-acting growth hormone in children with growth disorders: results from REAL8 phase 3 basket study presented at the joint Congress of ESPE and ESE

BAGSVAERD, Denmark I 12 May 2025 I Novo Nordisk today presented data from the phase 3 REAL8 basket study, which showed that once-weekly Sogroya ® (somapacitan) was non-inferior to the once-daily growth hormone Norditropin ® (somatropin) in improving yearly growth rate (as measured by height velocity [HV] at Week 52) in pre-pubertal children born small for gestational age (SGA) 1 , or with Noonan syndrome (NS) 2 , or with idiopathic short stature (ISS) 3 . In addition, superiority was achieved for once-weekly Sogroya ® versus daily growth hormone in children with NS 2 , as well as compared to lower doses of daily growth hormone in children born SGA 1 . REAL8 data showed that Sogroya ® was well-tolerated, with no safety or tolerability issues identified compared to once daily growth hormone 1-3 . Insulin-like growth factor 1 (IGF-1) response in patients treated with once-weekly Sogroya ® was similar to those treated with daily growth hormone 1-3 . Results from the Turner syndrome (TS) sub-study of REAL8 will be available later this year. These data were presented as three late-breaking abstracts at the first Joint Congress of the European Society for Paediatric Endocrinology (ESPE) and European Society of Endocrinology (ESE) in Copenhagen, Denmark 1-3 . “Children with growth failure face many health challenges beyond just being shorter than their peers. They often have metabolic disruptions and developmental difficulties that can seriously affect their wellbeing and quality of life, as well as long-term effects such as increased risk of cardiovascular disease or type 2 diabetes,” said Professor Agnès Linglart, Professor of Paediatrics at the Bicêtre Paris-Saclay University and Hospital, France, and one of the lead investigators on REAL8. “The REAL8 data presented today marks an important step forward in providing these patients with an effective, once-weekly option that can potentially reduce treatment burden and improve adherence and treatment outcomes.” The REAL8 trial achieved its primary endpoints for the first three sub-studies, demonstrating that once-weekly Sogroya ® was non-inferior to once-daily growth hormone treatment at Week 52 across the three indications presented: Non-adherence to growth hormone treatment is a common problem which puts successful treatment outcomes at risk. Daily injections can be a burden for children and their caregivers, leading to lack of adherence due to discomfort or pain at injection sites, inconvenience and disruption to daily life 5 . One study showed that missed daily injections resulted in a difference of 6.1 cm in height over 3 years when comparing nonadherent with adherent patients 4 . “Treatment adherence is an issue when it comes to improving outcomes in children with growth failure. Imagine if a child misses only one day of treatment each week, amounting to 52 missed days per year. Over a seven-year treatment window, this results in one year of missed treatment and can have a significant knock-on impact on their health,” said Martin Lange, executive vice president for Development at Novo Nordisk. “We are committed to providing a portfolio of growth hormone therapies with flexibility in administration timing and missed doses, which may better suit the needs of children with growth failure. These encouraging results from REAL8 mark a significant step forward in achieving that commitment.” In April 2025, based on the data from REAL8 and REAL9, the three indications (SGA, NS and ISS) were submitted for regulatory review in both the EU and US. About REAL8 The REAL8 study is part of the ongoing REAL clinical trial programme, it is a randomised, open-label, active-controlled, parallel-group, phase 3 trial evaluating the efficacy and safety of once-weekly Sogroya ® (somapacitan) in children born SGA, or with TS, NS or ISS. The primary treatment period was 52 weeks followed by a two-year safety extension phase 6 . REAL8 has an innovative basket trial design that is investigating once-weekly Sogroya ® (somapacitan) in four different but related indications (SGA, TS, NS and ISS) under one trial protocol 6 . This trial design allows for a more efficient clinical development process by speeding up recruitment and consolidating resources 7 , potentially bringing treatment to patients with these conditions sooner. This is the first time a trial design of this type has been implemented in the growth disorder space. In REAL8, pre-pubertal children with NS, TS or ISS were randomised to receive either once-weekly Sogroya ® (somapacitan) 0.24 mg/kg/week or once-daily somatropin 0.050 mg/kg/day; children born SGA were randomised to receive either somapacitan 0.24 mg/kg/week, or low dose of somatropin 0.035 mg/kg/day, or high dose of somatropin 0.067 mg/kg/day 6 . About REAL9 The REAL9 study is part of the ongoing REAL clinical trial programme, it is a single-group assignment, phase 3 study evaluating the safety and efficacy of once-weekly Sogroya ® (somapacitan) in children 10 years or older born SGA, or with TS, NS or ISS. The study will last for approximately 3 years 8 . About once-weekly Sogroya ® Once-weekly Sogroya ® (somapacitan) is a prescription human growth hormone analogue, similar to current daily growth hormone. It is currently approved for once-weekly treatment of children and adults who do not produce enough growth hormone 9,10 . Using albumin-binding prolongation technology, Sogroya ® attaches to albumin, a protein in the blood, to help delay its removal from the body. This well-established technology has been used for over 20 years in Novo Nordisk’s diabetes treatment. It allows for the growth hormone to work longer 11 . About Novo Nordisk Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com , Facebook , Instagram , X , LinkedIn and YouTube . SOURCE: Novo Nordisk

Clinical ResultPhase 3Drug Approval

12 May 2025

·www.novonordisk.com

Novo Nordisk A/S: Once-weekly Sogroya® (somapacitan) is an efficacious and well-tolerated long-acting growth hormone in children with growth disorders: results from REAL8 phase 3 basket study presented at the joint Congress of ESPE and ESE

Bagsværd, Denmark, 12 May 2025 – Novo Nordisk today presented data from the phase 3 REAL8 basket study, which showed that once-weekly Sogroya ® (somapacitan) was non-inferior to the once-daily growth hormone Norditropin ® (somatropin) in improving yearly growth rate (as measured by height velocity [HV] at Week 52) in pre-pubertal children born small for gestational age (SGA) 1 , or with Noonan syndrome (NS) 2 , or with idiopathic short stature (ISS) 3 . In addition, superiority was achieved for once-weekly Sogroya ® versus daily growth hormone in children with NS 2 , as well as compared to lower doses of daily growth hormone in children born SGA 1 . REAL8 data showed that Sogroya ® was well-tolerated, with no safety or tolerability issues identified compared to once daily growth hormone 1-3 . Insulin-like growth factor 1 (IGF-1) response in patients treated with once-weekly Sogroya ® was similar to those treated with daily growth hormone 1-3 . Results from the Turner syndrome (TS) sub-study of REAL8 will be available later this year. These data were presented as three late-breaking abstracts at the first Joint Congress of the European Society for Paediatric Endocrinology (ESPE) and European Society of Endocrinology (ESE) in Copenhagen, Denmark 1-3 . “Children with growth failure face many health challenges beyond just being shorter than their peers. They often have metabolic disruptions and developmental difficulties that can seriously affect their wellbeing and quality of life, as well as long-term effects such as increased risk of cardiovascular disease or type 2 diabetes,” said Professor Agnès Linglart, Professor of Paediatrics at the Bicêtre Paris-Saclay University and Hospital, France, and one of the lead investigators on REAL8. “The REAL8 data presented today marks an important step forward in providing these patients with an effective, once-weekly option that can potentially reduce treatment burden and improve adherence and treatment outcomes.” The REAL8 trial achieved its primary endpoints for the first three sub-studies, demonstrating that once-weekly Sogroya ® was non-inferior to once-daily growth hormone treatment at Week 52 across the three indications presented: Non-adherence to growth hormone treatment is a common problem which puts successful treatment outcomes at risk. Daily injections can be a burden for children and their caregivers, leading to lack of adherence due to discomfort or pain at injection sites, inconvenience and disruption to daily life 5 . One study showed that missed daily injections resulted in a difference of 6.1 cm in height over 3 years when comparing nonadherent with adherent patients 4 . “Treatment adherence is an issue when it comes to improving outcomes in children with growth failure. Imagine if a child misses only one day of treatment each week, amounting to 52 missed days per year. Over a seven-year treatment window, this results in one year of missed treatment and can have a significant knock-on impact on their health,” said Martin Lange, executive vice president for Development at Novo Nordisk. “We are committed to providing a portfolio of growth hormone therapies with flexibility in administration timing and missed doses, which may better suit the needs of children with growth failure. These encouraging results from REAL8 mark a significant step forward in achieving that commitment.” In April 2025, based on the data from REAL8 and REAL9, the three indications (SGA, NS and ISS) were submitted for regulatory review in both the EU and US. About REAL8 The REAL8 study is part of the ongoing REAL clinical trial programme, it is a randomised, open-label, active-controlled, parallel-group, phase 3 trial evaluating the efficacy and safety of once-weekly Sogroya ® (somapacitan) in children born SGA, or with TS, NS or ISS. The primary treatment period was 52 weeks followed by a two-year safety extension phase 6 . REAL8 has an innovative basket trial design that is investigating once-weekly Sogroya ® (somapacitan) in four different but related indications (SGA, TS, NS and ISS) under one trial protocol 6 . This trial design allows for a more efficient clinical development process by speeding up recruitment and consolidating resources 7 , potentially bringing treatment to patients with these conditions sooner. This is the first time a trial design of this type has been implemented in the growth disorder space. In REAL8, pre-pubertal children with NS, TS or ISS were randomised to receive either once-weekly Sogroya ® (somapacitan) 0.24 mg/kg/week or once-daily somatropin 0.050 mg/kg/day; children born SGA were randomised to receive either somapacitan 0.24 mg/kg/week, or low dose of somatropin 0.035 mg/kg/day, or high dose of somatropin 0.067 mg/kg/day 6 . About REAL9 The REAL9 study is part of the ongoing REAL clinical trial programme, it is a single-group assignment, phase 3 study evaluating the safety and efficacy of once-weekly Sogroya ® (somapacitan) in children 10 years or older born SGA, or with TS, NS or ISS. The study will last for approximately 3 years 8 . About once-weekly Sogroya ® Once-weekly Sogroya ® (somapacitan) is a prescription human growth hormone analogue, similar to current daily growth hormone. It is currently approved for once-weekly treatment of children and adults who do not produce enough growth hormone 9,10 . Using albumin-binding prolongation technology, Sogroya ® attaches to albumin, a protein in the blood, to help delay its removal from the body. This well-established technology has been used for over 20 years in Novo Nordisk's diabetes treatment. It allows for the growth hormone to work longer 11 . About Novo Nordisk Novo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com , Facebook , Instagram , X , LinkedIn and YouTube . Contacts for further information: References 1. Linglart A, Bottcher V, Rassmussen MH, et al . Weekly Somapacitan is Effective and Well-Tolerated in Children Born Small for Gestational Age: Randomised Phase 3 Trial. Oral presentation presented at the Joint Congress of ESPE and ESE 2025; 10-13 May 2025; Bella Center, Copenhagen, Denmark. JOINT4131. 2. Jorge A, Albanese A, Rasmussen MH, et al . Weekly Somapacitan is Effective and Well-Tolerated in Children with Noonan Syndrome: Randomised Phase 3 Trial. Poster presentation presented at the Joint Congress of ESPE and ESE 2025; 10-13 May 2025; Bella Center, Copenhagen, Denmark. JOINT4118. 3. Abuzzahab J, Dauber A, Rasmussen MH, et al . Weekly Somapacitan is Effective and Well-Tolerated in Children with Idiopathic Short Stature: Randomised Phase 3 Trial. Oral presentation presented at the Joint Congress of ESPE and ESE 2025; 10-13 May 2025; Bella Center, Copenhagen, Denmark. JOINT4048. 4. Loftus J, Miller BS, Parzynski CS , et al. Association of Daily Growth Hormone Injection Adherence and Height Among Children With Growth Hormone Deficiency. Endocr Pract . 2022;28:565-571. 5. Brod M, Hojbjerre L, Alolga SL , et al. Understanding Treatment Burden for Children Treated for Growth Hormone Deficiency. Patient . 2017;10:653-666. 6. ClinicalTrials.gov. NCT05330325. A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow (REAL 8). Available at: https://clinicaltrials.gov/study/NCT05330325. Last accessed: May 2025. 7. Definitive Healthcare. Basket trial. Available at: https://www.definitivehc.com/resources/glossary/basket-trial. Last accessed: April 2025. 8. ClinicalTrials.gov. NCT05723835. A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9 (REAL 9). Available at: https://clinicaltrials.gov/study/NCT05723835. Last accessed: May 2025. 9. Sogroya ® (somapacitan): SmPC. 2025 [online] Available at: https://www.ema.europa.eu/en/documents/product-information/sogroya-epar-product-information_en.pdf Last accessed: May 2025. 10. Sogroya ® (somapacitan-beco injection) US PI. 2025 [online] Available at: https://www.novo-pi.com/sogroya.pdf Last accessed: May 2025. 11. Johansson E, Nielsen AD, Demuth H , et al. Identification of Binding Sites on Human Serum Albumin for Somapacitan, a Long-Acting Growth Hormone Derivative. Biochemistry . 2020;59:1410-1419.

Clinical ResultPhase 3Drug Approval

100 Deals associated with Somapacitan

External Link

KEGG	Wiki	ATC	Drug Bank
D11194	Somapacitan	H01AC01	DB15093

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Growth hormone deficiency	United States	Novo Nordisk, Inc.	28 Aug 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dwarfism	Phase 3	United States	Novo Nordisk A/S	10 Aug 2022
Dwarfism	Phase 3	China	Novo Nordisk A/S	10 Aug 2022
Dwarfism	Phase 3	Japan	Novo Nordisk A/S	10 Aug 2022
Dwarfism	Phase 3	Austria	Novo Nordisk A/S	10 Aug 2022
Dwarfism	Phase 3	Belgium	Novo Nordisk A/S	10 Aug 2022
Dwarfism	Phase 3	Brazil	Novo Nordisk A/S	10 Aug 2022
Dwarfism	Phase 3	Bulgaria	Novo Nordisk A/S	10 Aug 2022
Dwarfism	Phase 3	Canada	Novo Nordisk A/S	10 Aug 2022
Dwarfism	Phase 3	Croatia	Novo Nordisk A/S	10 Aug 2022
Dwarfism	Phase 3	Finland	Novo Nordisk A/S	10 Aug 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05330325 (REAL8, NEWS) Manual	Phase 3	Growth Disorders	-	Sogroya	qrnnsdjjgg(hbzvuipuxx) = ukayffdtfe axgbzqkfrh (xemvihgfhy ) View more	Similar	12 May 2025
				Norditropin	qrnnsdjjgg(hbzvuipuxx) = tuphexnmfu axgbzqkfrh (xemvihgfhy ) View more
NCT04970654 (CTgov)	Phase 3	Growth hormone deficiency	110	Norditropin (Norditropin)	rqvwvchltg(erdcexfetj) = tmwxicpzlj rynkzmibzz (zvjlklvjvb, 2.3) View more	-	10 Dec 2024
				Somapacitan (Somapacitan)	rqvwvchltg(erdcexfetj) = azlakscuge rynkzmibzz (zvjlklvjvb, 2.1) View more
NCT03811535 (REAL4, ENDO2024)	Phase 3	Growth hormone deficiency	200	Somapacitan 0.16 mg/kg/week	pglfwikpmr(squyarhqpv) = During the extension period (week 52 to 156), a low proportion of the participants reported injection site reactions mugdcebwru (yiafylbaey ) View more	Positive	01 Jun 2024
				Norditropin 0.034 mg/kg/day
NCT03811535 (REAL4, Pubmed \| Clin Endocrinol (Oxf))	Phase 3	Growth hormone deficiency	-	Somapacitan (0.16 mg/kg/week)	nheigqqnlq(fjyrzvffxn) = qbyzgafgzj gwkhgjsqml (yurzsmlkuw )	Positive	01 Apr 2024
				Daily GH (0.034 mg/kg/day)	nheigqqnlq(fjyrzvffxn) = kwbokcxjev gwkhgjsqml (yurzsmlkuw )
NCT03811535 (REAL4, ENDO2023)	Phase 3	-	68	Somapacitan	wqtghktvar(yvyoomeioj) = ngktmiwwwr usiksprxon (svdxbyzfqs ) View more	Positive	05 Oct 2023
NCT03811535 (Pubmed)	Phase 3	Growth hormone deficiency	200	Somapacitan	cscrbuajvr(rmachtfvji) = fijgbsoiwc ahajfqejsd (ceqsqbqfdq )	-	05 Jul 2023
				Daily GH	cscrbuajvr(rmachtfvji) = kbhogsbjdg ahajfqejsd (ceqsqbqfdq )
NCT03811535 (REAL4, ENDO2022)	Phase 3	Growth hormone deficiency	-	Somapacitan 0.16 mg/kg/week	rfeytbirzj(dgxqtzqmgq) = roxnnfnlfu orlauhacqp (awdcmakbxt ) View more	Positive	01 Nov 2022
				Daily GH 0.034 mg/kg/day Norditropin	rfeytbirzj(dgxqtzqmgq) = ixmbcoxchq orlauhacqp (awdcmakbxt ) View more
NCT02616562 (REAL 3, ENDO2022)	Phase 2	Growth hormone deficiency	45	Daily GH 0.034 mg/kg/day	rmymjrayut(lhhhlccgdc) = one patient in the somapacitan/somapacitan group experienced five injection-site reactions; none occurred in the daily GH/somapacitan group zxjqdkqvti (bmydaewegx ) View more	Positive	01 Nov 2022
				Somapacitan/somapacitan
NCT03878446 (RF26 \| PMON335, ENDO2022)	Phase 2	Small-for-dates baby	62	Somapacitan 0.16 mg/kg/week	uuxtdsagok(xgsuzzudgg) = yokdxoeveb nmmpnbnwmx (wekiinfsyi )	Positive	01 Nov 2022
				Somapacitan 0.20 mg/kg/week	uuxtdsagok(xgsuzzudgg) = futsqdtzmz nmmpnbnwmx (wekiinfsyi )
NCT03878446 (ESPE2022)	Phase 2	Small-for-dates baby	62	Somapacitan 0.16 mg/kg/week	eyksvgelcg(xkmjuwibcf) = detected in one child in the GH 0.067 mg/kg/day arm; none were detected in other treatment arms adwhkadecg (braxogifhd ) View more	-	15 Sep 2022
				Somapacitan 0.20 mg/kg/week

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