The Growth Hormone Deficiency Reversal Trial: Effect on final height of discontinuation vs continuation of growth hormone treatment in pubertal children with isolated growth hormone deficiency – A non-inferiority randomised controlled trial

Start Date17 May 2023

Sponsor / Collaborator

University College London

NCT05308927

/ Enrolling by invitationNot Applicable

French Registry of Children Treated With Norditropin® for Short Stature Associated With Noonan Syndrome

This is a non-interventional registry of children treated with Norditropin® for short stature due to Noonan Syndrome (NS). This study aims to provide data on long-term growth evolution and safety of Norditropin® as well as Health Related Quality of Life (HRQoL) data. This registry will include the entirety of children treated with Norditropin® for short stature due to NS over the inclusion period. The decision to initiate treatment with commercially available Norditropin® is made by the patient/parents/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.

Start Date16 Mar 2022

Sponsor / Collaborator

Novo Nordisk A/S

NCT04042428

/ CompletedPhase 1IIT

Generation of Biological Samples Positive to Somatropin for Anti-doping Control

Background:
Somatropin, also known as recombinant growth hormone (rhGH), is one of the World Anti-Doping Agency (WADA) prohibited substances. Its consumption in athletes has been banned since 1990, as it is known to improve physical performance.
Hypothesis:
The subcutaneous administration of recombinant somatropin (rhGH) in healthy subjects allows obtaining positive doping samples.
The concentrations of hGH variants (isoforms) and biomarkers can be measured in serum.
Objectives:
Primary objective: To generate enough serum samples positive to recombinant somatropin in order to be analyzed as control samples by anti-doping laboratories.
Secondary objective: To determine the analytical parameters necessary to detect the administration of recombinant somatropin in healthy volunteers by direct and/or indirect methods.
Methods:
Phase I, open, randomized clinical trial, with a treatment condition (recombinant somatropin or rhGH) administered subcutaneously to 4 subjects (2:1 ratio). Control samples of the study correspond to basal samples of 2 subjects who do not receive any treatment.

Start Date25 Oct 2019

Sponsor / Collaborator

Consorci Mar Parc de Salut de Barcelona

100 Clinical Results associated with Somatropin(Novo Nordisk A/S)

100 Translational Medicine associated with Somatropin(Novo Nordisk A/S)

100 Patents (Medical) associated with Somatropin(Novo Nordisk A/S)

100

Literatures (Medical) associated with Somatropin(Novo Nordisk A/S)

01 Jan 2026·ENDOCRINE JOURNAL

Long-term effectiveness and safety of daily growth hormone therapy in Japanese children with Noonan syndrome: a post-marketing surveillance study

Article

Author: Horikawa, Reiko ; Muroya, Koji ; Endo, Takaaki ; Ferran, Jean-Marc ; Kawai, Masanobu ; Yamagishi, Hiroyuki ; Pietropoli, Alberto

Reports on long-term safety and effectiveness of daily GH replacement therapy in Japanese children with short stature due to Noonan syndrome (NS) are limited. This post-marketing, prospective, non-interventional study (ClinicalTrials.gov NCT03435627) evaluated the long‑term safety and effectiveness of daily GH therapy in this patient population. The study took place at 22 sites in Japan during November 2017-January 2022. Seventy participants were enrolled and received Norditropin^® at least once during the study as per routine clinical practice: new patients (n = 35) received Norditropin^® (somatropin) after study initiation and existing patients (n = 35) were previously enrolled in a 4-year trial of Norditropin^® for NS (ClinicalTrials.gov NCT01927861). The main outcome measures were adverse drug reactions (ADRs) and serious adverse events (SAEs). Improvements in height were also measured. In total, four new patients experienced five ADRs and one new patient experienced one SAE. Five existing patients experienced one ADR each and three existing patients experienced one SAE each. One existing patient with pre-existing cardiomyopathy who experienced an SAE (arrhythmia) died during the study; Norditropin^® causality was judged 'unlikely.' Change from baseline in mean (SD) height standard deviation score (SDS), according to Japanese and NS standards, was 1.01 (0.5) and 0.92 (0.3) for new patients and 1.01 (1.0) and 1.31 (0.8) for existing patients, respectively. Our results show that Norditropin^® effectively improved height outcomes in Japanese children with NS and was well tolerated with no new safety issues identified. For patients with NS and cardiomyopathy receiving GH therapy, careful monitoring is advised.

08 Sep 2025·Endocrine Connections

Better growth outcomes in GH-deficient children treated younger than 2 years of age

Article

Author: Polak, Michel ; Rohrer, Tilman Robert ; Pietropoli, Alberto ; Miller, Bradley S ; Kotnik, Primož ; Blair, Jo ; Kelepouris, Nicky ; Olsen, Anne Helene

Background:

Limited data are available on the growth response to growth hormone (GH) treatment in very young children with GH deficiency (GHD). In the present analysis, we compared clinical outcomes after GH treatment in children with GHD aged <2 and ≥2 years at the start of GH treatment.

Methods:

We analysed pooled data from two observational studies of paediatric patients who received Norditropin® treatment: NordiNet® IOS (NCT00960128) and the ANSWER Program (NCT01009905). Patients with GHD, who remained pre-pubertal after 1 year of treatment, were grouped by age at treatment start (<2 years; ≥2 years). The primary effectiveness outcome was change in height standard deviation score (SDS) after 1 and 10 years. We also investigated the frequency of non-serious adverse drug reactions (ADRs), serious ADRs and serious adverse events (SAEs).

Results:

In total, 507 and 7,486 children initiated treatment at <2 and ≥2 years of age, respectively. Height SDS (mean change (SD) from baseline) improved after 1 year of treatment in both groups and was greater in children initiating treatment at <2 years than in those initiating treatment at ≥2 years (1.4 (1.2) and 0.75 (0.5), respectively); these findings were sustained after 10 years of treatment (3.2 (1.7) and 2.2 (1.3), respectively). SAEs were more frequent in children initiating treatment at <2 years vs ≥ 2 years (3.3 vs 0.67%, respectively).

Conclusions:

Children aged <2 years at GH treatment initiation had better height outcomes, but more SAEs, after 1 and 10 years of GH treatment compared to children starting GH at age ≥2 years.

Trial registration:

NordiNet® IOS, ClinicalTrials.gov NCT00960128; ANSWER Program, ClinicalTrials.gov NCT01009905.

Plain language summary:

Data from two large studies showed that children with growth hormone deficiency (GHD) who began treatment with Norditropin® under 2 years of age had better growth than those first treated at or above 2 years of age, but also had more side effects. This highlights the value of early diagnosis, treatment and close monitoring of children with GHD.

30 Apr 2025·EUROPEAN JOURNAL OF ENDOCRINOLOGY

Efficacy, safety, and insulin-like growth factor I of weekly somapacitan in children with growth hormone deficiency: 3-year results from REAL4

Article

Author: Kim, Ho-Seong ; Rasmussen, Michael Højby ; Lemminger, Anders Krogh ; Mori, Jun ; Miller, Bradley S ; Polak, Michel ; Blair, Joanne C ; Horikawa, Reiko ; Frystyk, Jan ; Böttcher, Volker ; Maniatis, Aristides

Abstract:

Objective:

Somapacitan is a long-acting GH approved for once-weekly treatment of GH deficiency (GHD). This study aims to evaluate the efficacy and tolerability of somapacitan after 3 years of treatment and 2 years after switch from daily GH in children with GHD.

Design:

Randomized, multi-national, open-labelled, active-controlled parallel-group phase 3 trial, with a 52-week main phase and 3-year safety extension (NCT03811535).

Methods:

Treatment-naïve children with GHD were randomized (2:1) to continuous somapacitan (0.16 mg/kg/week; “soma/soma” group) or daily GH (Norditropin®; 0.034 mg/kg/day) followed by somapacitan (0.16 mg/kg/week; “switch” group).

Results:

Of 200 participants, 188 completed 3 years of treatment. Sustained growth was observed in both groups. At week 156, mean (SD) height velocity (HV) between weeks 104 and 156 was 7.4 (1.5) cm/year in the soma/soma group and 7.8 (1.4) cm/year in the switch group. At week 156, the soma/soma and switch groups had reached a mean (SD) height SD score (HSDS) of −0.95 (0.98) and −1.08 (0.93), respectively, and were approaching the mean mid-parental HSDS of −0.74 (for both groups). Mean total insulin-like growth factor I (IGF-I) SDS during year 3 was similar between groups and within normal range (−2.0 to +2.0). Bioactive IGF-I and bioactive IGF-I to IGF-I ratio were similar between groups. Somapacitan was well tolerated, with low proportions reporting injection-site reactions.

Conclusions:

Sustained efficacy and tolerability were observed for continuous somapacitan treatment for 3 years, and for 2 years after the switching from daily GH treatment. HSDS in both groups was approaching mean mid-parental HSDS.

Clinical trial registration:

NCT03811535

News (Medical) associated with Somatropin(Novo Nordisk A/S)

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 Somatropin(Novo Nordisk A/S)

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KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Growth Disorders	China	Novo Nordisk A/S	22 Jun 1999
Growth hormone deficiency	China	Novo Nordisk A/S	22 Jun 1999
Dwarfism	Japan	Novo Nordisk Pharma Ltd.	18 Jan 1991
Dwarfism, Pituitary	Japan	Novo Nordisk Pharma Ltd.	30 Nov 1988

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Idiopathic short stature	Phase 3	Italy	-	07 Jul 2022
Turner Syndrome	Phase 3	Italy	-	07 Jul 2022
Bone Diseases, Metabolic	Phase 3	France	Novo Nordisk A/S	01 Mar 2013
Delayed Puberty	Phase 3	France	Novo Nordisk A/S	01 Mar 2013
Hemodialysis complication	Phase 3	Spain	Novo Nordisk A/S	25 Sep 2007
Noonan Syndrome	Phase 3	Sweden	Novo Nordisk A/S	12 May 2005
Fetal Growth Retardation	Phase 3	Japan	Novo Nordisk A/S	18 Aug 2004
Small-for-dates baby	Phase 3	Japan	Novo Nordisk A/S	18 Aug 2004
Athletic Injuries	Phase 2	United States	Novo Nordisk A/S	08 Oct 2019
Brain Concussion	Phase 2	United States	Novo Nordisk A/S	08 Oct 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03878446 (RF26 \| PMON335, ENDO2022)	Phase 2	Small-for-dates baby	62	Somapacitan 0.16 mg/kg/week	yqnrnpsior(idwasnzjjc) = jeziqamzes twkocfvkdh (bhisxdjpau )	Positive	01 Nov 2022
NCT03878446 (RF26 \| PMON335, ENDO2022)	Phase 2	Small-for-dates baby	62	Somapacitan 0.20 mg/kg/week	yqnrnpsior(idwasnzjjc) = srrhtewamg twkocfvkdh (bhisxdjpau )	Positive	01 Nov 2022
Pubmed \| J Clin Endocrinol Metab	Phase 1	Dwarfism heterozygous mutation in ACAN \| insulin-like growth factor I concentration	10	Recombinant human growth hormone (rhGH) 50 µg/kg/day	ltpojccarz(hcfpqfyfct) = znuodndbpm yuklbyyiyu (vczbhkofat )	Positive	19 Apr 2022
NCT02616562 (Real 3, ENDO2020)	Phase 2	Growth hormone deficiency	74	Somapacitan 0.04 mg/kg/wk	msiptgehgs(wuplrgnqmz) = Nasopharyngitis, influenza, allergic rhinitis, gastroenteritis qflgccneaq (zqcsxxduef ) View more	Positive	08 May 2020
NCT02616562 (Real 3, ENDO2020)	Phase 2	Growth hormone deficiency	74	Somapacitan 0.08 mg/kg/wk		Positive	08 May 2020
Pubmed \| Patient Prefer Adherence	Phase 4	-	103	Norditropin NordiFlex	niqvjvhqpe(xqasalrfhe) = gdhbixnllb pdtvrznlrl (hjvayjngqj ) View more	-	01 May 2013
Pubmed \| Patient Prefer Adherence	Phase 4	-	103	Norditropin NordiFlex	nbhfawvpuz(euhkpiryzy) = dqiacorrml rffnqdcfhp (xhxtsdxjzm ) View more	-	01 May 2013

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis