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

04 Mar 2026·EUROPEAN JOURNAL OF ENDOCRINOLOGY

Somapacitan in children born small for gestational age: a randomized controlled phase 3 trial

Article

Author: Silverman, Lawrence ; Soltysik, Kamil ; Böttcher, Volker ; Longui, Carlos Alberto ; Linglart, Agnès ; Højby, Michael ; Kashimada, Kenichi

Abstract:

Objective:

Short stature in children born small for gestational age (SGA) is treated with daily injections of recombinant growth hormone (GH), a significant treatment burden. The objective of this study is to demonstrate the efficacy and safety of once-weekly somapacitan, a long-acting GH, in short children born SGA.

Design:

REAL8 (NCT05330325) is a multinational, multicenter, randomized, open-labeled, active comparator, phase 3 basket study including four non-GH deficiency indications comprising a 52-week main phase and 104-week extension. Here, we present 52-week results from the SGA sub-study.

Methods:

142 prepubertal, treatment-naïve children born SGA in 78 sites across 26 countries were randomized 2:1:1 to somapacitan .24 mg/kg/week or daily GH 0.035 or 0.067 mg/kg/day, all administered subcutaneously. 140 completed the main 52-week treatment period.

Results:

The primary endpoint, estimated mean height velocity at week 52, was 11.0 cm/year for somapacitan vs. 9.4 cm/year [ETD = 1.6(0.91, 2.23)95%CI] and 11.1 cm/year [ETD = -0.1(−0.75, 0.60)95%CI] for daily GH 0.035 and 0.067 mg/kg/day, respectively. Noninferiority was confirmed for somapacitan compared to both daily GH groups. Superiority was demonstrated for somapacitan versus daily GH 0.035 mg/kg/day. Safety profiles were similar between treatment groups. As expected, somapacitan reduced disease burden at week 52, as for daily GH 0.067 mg/kg/day, while somapacitan was associated with reduced treatment burden.

Conclusion:

Somapacitan provides similar efficacy, safety, and tolerability as daily GH in short children born SGA after 52 weeks of treatment. Somapacitan may be an attractive alternative to daily GH in this population, reducing treatment burden to improve adherence and treatment outcomes.

01 Mar 2026·GROWTH HORMONE & IGF RESEARCH

Safety and efficacy of somapacitan in adults with growth hormone deficiency who were switched from daily growth hormone therapy: A systematic review and meta-analysis

Article

Author: Chatterjee, Subhankar ; Pappachan, Joseph M ; Dutta, Deep ; Kamrul-Hasan, A B M ; Nagendra, Lakshmi ; Ashraf, Ambika P

BACKGROUND:

The safety and efficacy of somapacitan, a novel long-acting growth hormone (GH) formulation, in adults with GH deficiency (GHD) remain insufficiently explored in systematic reviews and meta-analyses (SR/MA). We aimed to fill this knowledge gap.

METHODS:

Databases were searched to identify RCTs and real-world studies involving adults with GHD who had previously been treated with daily GH and switched to once-weekly somapacitan. The primary outcome was the risk of adverse events (AEs); additional outcomes included treatment satisfaction, body composition measures, and insulin-like growth factor-1 standard deviation scores (IGF-1 SDS).

RESULTS:

This SR/MA included five studies (N = 297); four RCTs (n = 286) with a daily GH comparator group were meta-analyzed. Compared to daily GH, somapacitan increased the risk of all AEs (RR 1.31, 95 % CI [1.07, 1.61], P = 0.01), but not the risk of serious AEs or other specific AEs. Glucose homeostasis was less affected by somapacitan, indicated by a lesser increment in HbA1c in the somapacitan group and larger increases in fasting insulin and HOMA-IR in the daily GH group. The convenience score increased more with somapacitan, while effectiveness and satisfaction scores changed similarly in both groups. No differences in body composition changes were observed, but somapacitan improved lumbar spine bone mineral content and density in one study. By the end, IGF-1 SDS values were comparable (MD -0.05 [-0.24, 0.15], P = 0.64).

CONCLUSION:

Somapacitan is as effective as daily GH in treating adults with GHD, with a reasonable safety profile and modest benefits for glucose homeostasis, as well as treatment convenience.

06 Feb 2026·Journal of the Endocrine Society

Patient and Caregiver Preferences for Once-Weekly Injection Devices for the Treatment of Growth Hormone Deficiency

Article

Author: Kennedy, Clare ; Wayser, Graceanne R ; Miller, Bradley S ; Chen, Jing Voon ; Mason, Brad ; Yuen, Kevin C J ; Kelepouris, Nicky

Abstract:

Context:

Once-weekly long-acting growth hormone (GH) analogue (LA-GHA) treatments offer an alternative to once-daily GH injections for the treatment of children and adults with GH deficiency (GHD). With these new LA-GHA options, it is important to understand patients’ and caregivers’ treatment preferences.

Objective:

This work aimed to understand the injection/device attributes important to patients with GHD and caregivers when choosing LA-GHA treatment options.

Methods:

In this cross-sectional study, a targeted literature review and qualitative interviews informed the development of an online survey. The survey included a discrete choice experiment, comprising a series of choice tasks. Respondents selected between hypothetical, experimentally designed, once-weekly LA-GHA device features corresponding to currently available devices. Study participants were patients/caregivers in the United States, self-reporting a GHD diagnosis and current short-acting GH injection use: adults (aged ≥18 years), caregivers of children (aged 3-11 years), and dyads of adolescents (aged 12-17 years) and their caregivers.

Results:

In total, 100 participants completed the survey: 50 adults, 25 caregivers, and 25 adolescent/caregiver dyads. Overall, the most important LA-GHA attributes identified were postinjection pain (27%), the number of injections needed for 1 full dose (23%), and the time needed to prepare the device before each injection (16%). The profile similar to somapacitan-beco had the highest predicted choice probability (82%) compared with the profiles similar to lonapegsomatropin-tcgd (16%) and somatrogon-ghla (2%).

Conclusion:

Understanding patient and caregiver preferences for LA-GHA devices with less injection pain and greater ease of use highlights the value of shared decision-making, potentially leading to better treatment adherence and subsequent clinical outcomes.

News (Medical) associated with Somapacitan

27 Feb 2026

·www.prnewswire.com

FDA approves Novo Nordisk's Sogroya® as the first and only once-weekly, long-acting growth hormone for three additional pediatric indications

New indications expand treatment options for appropriate children aged 2.5 years and older with Idiopathic Short Stature (ISS), born Small for Gestational Age (SGA), or Noonan Syndrome (NS) 1 Sogroya ® (somapacitan-beco) is a once-weekly treatment option, offering an alternative to once-daily therapy, which may help address the common challenge of non-adherence associated with daily injections2 These FDA approvals build on decades of treatment innovation for growth disorders from Novo Nordisk Sogroya® now has the broadest range of approved indications among long-acting growth hormones PLAINSBORO, N.J., Feb. 27, 2026 /PRNewswire/ -- Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved three new indications for once-weekly Sogroya® (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg, a long-acting growth hormone.1 Sogroya® is now indicated for children aged 2.5 years and older with Idiopathic Short Stature (ISS), short stature born Small for Gestational Age (SGA) and with no catch-up growth by 2 years of age, or growth failure associated with Noonan Syndrome (NS).1 Sogroya® is also indicated for children aged 2.5 years and older and adults with growth hormone deficiency (GHD).1 "Daily injections have defined the growth disorder treatment paradigm for more than 40 years. Our scientific leadership and focus on advancing care in rare diseases led us to the development of Sogroya® – a once‑weekly growth hormone therapy – which may help address the challenge of daily injections while offering patients and families a therapeutic option that delivers efficacy and safety," said Nicky Kelepouris, Rare Endocrine Disorders-US Medical Lead. "These new approvals expand the patient populations that can be helped by Sogroya® and reflect our strategic focus on delivering meaningful, evidence‑based innovation for children living with growth disorders." Compliance to 365 daily injections per year for growth hormone treatment can be a common challenge for children and their caregivers. Having an alternative once-weekly option may assist with this challenge.2,3,4 "Families and healthcare professionals now have the option to consider a once-weekly growth hormone as treatment with 313 injection free days per year for their children 2.5 years and older with ISS, NS, and born SGA," said Dr. Aristides Maniatis, Founder, Rocky Mountain Pediatric Endocrinology (Centennial, CO) and an investigator in the trial. "Sogroya® is an effective alternative to daily injections that supports children's growth goals and may help fit into their routine." REAL8, the pivotal study for these approvals, contained three sub studies that achieved their primary endpoint, demonstrating that once-weekly Sogroya® (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg was non-inferior to once-daily growth hormone treatment for mean annualized height velocity (AHV) at Week 52 across these three indications in children aged 2.5 years and older: In children with ISS, Sogroya® demonstrated non-inferiority in mean AHV compared with daily somatropin (10.2 vs 10.5 cm/year).1 The dose of 0.05 mg/kg/day of daily somatropin is less than maximum dose approved dose (0.067 mg/kg/day) for use in pediatric patients in the US.1 In children born SGA with no catch up by 2 years of age, Sogroya® demonstrated non-inferiority compared to both daily growth hormone doses (0.035 mg/kg/day and 0.067 mg/kg/day) with a mean AHV of 11.0 cm/year vs 9.4 cm/year vs 11.1 cm year respectively; daily growth hormone dose of 0.035 mg/kg/day is less than the maximum approved dose (0.067 mg/kg/day) in the US.1 In children with growth failure associated with NS, Sogroya® demonstrated non-inferiority in mean AHV compared to daily somatropin (10.4 vs 9.2 cm/year); the daily somatropin dose of 0.050 mg/kg/day used is less than the maximum approved dose (0.066 mg/kg/day) in the US.1 In REAL8, the adverse reactions occurring in ≥10% of patients treated with Sogroya® across all three indications were respiratory tract infection, nasopharyngitis, ear infection, and diarrhea. Additional reactions occurring in ≥10% of patients treated with Sogroya® included: headache in ISS and NS; cough, pyrexia, and vomiting in NS and SGA; and injection site reaction in ISS.1 Please see below for important safety information and please click here for the full Prescribing Information. Novo Nordisk also submitted a supplemental application for Sogroya® for approval in the US for Turner Syndrome. A decision is expected later this year. About REAL8 The REAL8 study is part of the ongoing REAL clinical trial program. It is a multi-center, randomized, open-label, active-comparator, phase 3 basket study conducted in growth hormone treatment-naïve, pre-pubertal pediatric patients with short stature born Small for Gestational Age (SGA), Noonan Syndrome (NS), or Idiopathic Short Stature (ISS). The primary treatment period was 52 weeks, and the study is currently in a two-year safety extension phase.1 This is the first time a trial design of this type has been implemented in the growth disorder space. In the study, 142 pediatric patients aged 2.6 to 10.7 years with SGA were randomized to Sogroya® 0.24 mg/kg/week (n=70), once-daily somatropin 0.035 mg/kg/day (n=37), or once-daily somatropin 0.067 mg/kg/day (n=35). Dose of 0.035 mg/kg/day of daily somatropin is less than maximum dose (0.067 mg/kg/day) approved for use in pediatric patients with SGA in the US.1 Seventy-seven pediatric patients aged 2 to 11.1 years with NS were randomized to Sogroya® 0.24 mg/kg/week (n=49) or once-daily somatropin 0.05 mg/kg/day (n=28). Dose of 0.05 mg/kg/day of daily somatropin is less than maximum dose (0.066 mg/kg/day) approved for use in pediatric patients with NS in the US.1 Eighty-eight pediatric patients aged 2.8 to 10.8 years with ISS were randomized to 0.24 mg/kg/day (n=60) or once-daily somatropin 0.05 mg/kg/day (n=28). Dose of 0.05 mg/kg/day of daily somatropin is less than maximum dose (0.067 mg/kg/day) approved for use in pediatric patients with ISS in the US.1 About once-weekly Sogroya® Once-weekly Sogroya® (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg is a prescription human growth hormone analogue.5 On February 27, 2026, once-weekly Sogroya® was approved in the US for children aged 2.5 years of age and older with Idiopathic Short Stature (ISS), short stature born Small for Gestational Age (SGA) and with no catch-up growth by 2 years of age, or growth failure associated with Noonan Syndrome (NS). Sogroya® was previously approved in the US for the replacement of endogenous growth hormone in adults with growth hormone deficiency (August 28, 2020) and for pediatric patients aged 2.5 years and older with growth failure due to inadequate secretion of endogenous growth hormone (April 28, 2023). What is Sogroya® Sogroya® (somapacitan-beco) injection 5 mg, 10 mg or 15 mg is a prescription medicine that contains human growth hormone, the same growth hormone made by the body. Sogroya® is given by injection under the skin (subcutaneous). Sogroya® is used to treat children 2.5 years of age and older who: are not growing because of low or no growth hormone are short (in stature) and were born small (Small for Gestational Age-SGA) and have not caught up in growth by age 2 years are not growing and have Noonan Syndrome (NS) have Idiopathic Short Stature (ISS) Sogroya® is used to treat adults who do not make enough growth hormone Important Safety Information Do not use Sogroya® if: you have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing problems you have cancer or other tumors you are allergic to somapacitan-beco or any of the ingredients in Sogroya ® your healthcare provider tells you that you have certain types of eye problems caused by diabetes you are a child with closed bone growth plates you are a child with Prader-Willi syndrome who is severely obese or has breathing problems including sleep apnea (briefly stopping breathing during sleep) Before taking Sogroya®, tell your healthcare provider about all of your medical conditions, including if you: have had heart or stomach surgery, trauma, or serious breathing problems are taking replacement therapy with glucocorticoids have had cancer or any tumor have thyroid glad problems have diabetes have liver problems have adrenal gland problems are a child with a history of worsening of curvature of the spine (scoliosis) are pregnant or plan to become pregnant. It is not known if Sogroya ® will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant are breastfeeding or plan to breastfeed. It is not known if Sogroya ® passes into your breast milk. You and your healthcare provider should decide if you will take Sogroya ® while you breastfeed Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Sogroya® may affect the way some medicines work, and some medicines may affect how Sogroya® works. How should I use Sogroya® ? Use Sogroya® exactly as your healthcare provider tells you to Use Sogroya® 1 time each week If you miss a dose of Sogroya®, the missed dose can be taken within 3 days (72 hours) after the scheduled dosing day. One-time weekly dosing for the next dose can be started again on the regularly scheduled dosing day If more than 3 days (72 hours) have passed, skip the missed dose, and take your next dose on the regularly scheduled dosing day Sogroya® pens are for use by 1 person only Do not share your Sogroya® pens and needles with another person, even if the needle has been changed. You may give another person an infection or get an infection from them What are the possible side effects of Sogroya® ? Sogroya® may cause serious side effects, including: high risk of death in people who have critical illnesses because of heart or stomach surgery, trauma, or serious breathing problems increased risk of growth of cancer or a tumor that is already present and increased risk of the return of cancer or a tumor in people who were treated with radiation to the brain or head as children and who developed low growth hormone problems. Your or your child's healthcare provider will need to monitor you or your child for a return of cancer or a tumor. Contact the healthcare provider if you or your child start to have sudden changes in behavior, headaches, vision problems, or changes in moles, birthmarks, or the color of your or your child's skin new or worsening high blood sugar (hyperglycemia) or diabetes. You or your child's blood sugar may need to be monitored during treatment with Sogroya® increase in pressure in the skull (intercranial hypertension). If you or your child have headaches, eye problems, nausea or vomiting, contact the healthcare provider serious allergic reactions. Get medical help right away if you or your child have the following symptoms: swelling of your face, lips, mouth, or tongue, trouble breathing, wheezing, severe itching, skin rashes, redness, or swelling, dizziness or fainting, fast heartbeat or pounding in your chest, sweating your or your child's body holding too much fluid (fluid retention) such as swelling in the hands and feet, pain in your or your child's joints or muscles or nerve problems that cause pain, burning or tingling in the hands, arms, legs, and feet. Tell your or your child's healthcare provider if you or your child have any of these signs or symptoms of fluid retention decrease in a hormone called cortisol. The healthcare provider will do blood tests to check your or your child's cortisol levels. Tell your or your child's healthcare provider if you or your child have darkening of the skin, severe fatigue, dizziness, weakness, or weight loss decrease in thyroid hormone levels. Decreased thyroid hormone levels may affect how well Sogroya® works. The healthcare provider will do blood tests to check you or your child's thyroid hormone levels severe and constant abdominal pain. This could be a sign of pancreatitis. Tell your or your child's healthcare provider if you or your child has any new abdominal pain loss of fat and tissue weakness in the area of skin you or your child inject. Talk to your or your child's healthcare provider about rotating the areas where you or your child inject Sogroya® worsening of curvature of the spine in children (scoliosis) hip and knee pain or a limp in children (slipped capital femoral epiphysis). This may lead to a serious condition where bone tissue dies due to lack of blood supply (osteonecrosis). Get medical help right away if your child develops a limp or has hip or knee pain high risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems, including sleep apnea increase in phosphorus, alkaline phosphatase, and parathyroid hormone levels in your blood. You or your child's healthcare provider will do blood tests to check this The most common side effects of Sogroya® in children include: cough, common cold, diarrhea, ear infection, headache, fever, pain in extremity, reaction to injection, respiratory tract infection, and vomiting The most common side effects of Sogroya® in adults include: back pain, joint pain, indigestion, sleep problems, dizziness, swelling of the tonsils (tonsillitis), swelling in the feet and hands (peripheral edema), vomiting, low cortisol levels (adrenal insufficiency), high blood pressure, increase in the level of an enzyme in your blood called creatine phosphokinase, weight gain, and low red blood cells (anemia) Please see prescribing information at About Novo Nordisk Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With a US presence spanning 40 years, Novo Nordisk US is headquartered in New Jersey and employs approximately 10,000 people throughout the country across more than 10 manufacturing, R&D and corporate locations in eight states plus Washington DC. For more information, visit novonordisk-us.com, Facebook, Instagram, and X. Contacts for further information References Sogroya [package insert]. Plainsboro, NJ: Novo Nordisk Inc. Christiansen JS, Backeljauw PF, Bidlingmaier M, et al. Growth Hormone Research Society perspective on the development of long-acting growth hormone preparations. Eur J Endocrinol. 2016 Jun;174(6):C1-8. 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. Brod M, Hojbjerre L, Alolga SL, et al. Understanding treatment burden for children treated for growth hormone deficiency. Patient. 2017;10:653-666. Johannson 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. Sogroya® is a registered trademark of Novo Nordisk Health Care AG. Novo Nordisk is a registered trademark of Novo Nordisk A/S. © 2026 Novo Nordisk All rights reserved. US26SOM00057 February 2026 SOURCE Novo Nordisk 21% more press release views with Request a Demo

Drug ApprovalPhase 3Clinical Result

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

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
Idiopathic short stature	United States	Novo Nordisk, Inc.	27 Feb 2026
Noonan Syndrome	United States	Novo Nordisk, Inc.	27 Feb 2026
Small-for-dates baby	United States	Novo Nordisk, Inc.	27 Feb 2026
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	NDA/BLA	China	Novo Nordisk A/S	27 Nov 2025
Turner Syndrome	Phase 3	United States	Novo Nordisk A/S	10 Aug 2022
Turner Syndrome	Phase 3	China	Novo Nordisk A/S	10 Aug 2022
Turner Syndrome	Phase 3	Japan	Novo Nordisk A/S	10 Aug 2022
Turner Syndrome	Phase 3	Austria	Novo Nordisk A/S	10 Aug 2022
Turner Syndrome	Phase 3	Belgium	Novo Nordisk A/S	10 Aug 2022
Turner Syndrome	Phase 3	Brazil	Novo Nordisk A/S	10 Aug 2022
Turner Syndrome	Phase 3	Bulgaria	Novo Nordisk A/S	10 Aug 2022
Turner Syndrome	Phase 3	Canada	Novo Nordisk A/S	10 Aug 2022
Turner Syndrome	Phase 3	Croatia	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, Pubmed \| Eur J Endocrinol)	Phase 3	-	77	Somapacitan 0.24 mg/kg/week	oyuitnngjk(kzlgrdesbx) = iydwtyvenn visagxgonb (boidhwfjuq ) View more	Positive	03 Mar 2026
				daily GH 0.050 mg/kg/day	oyuitnngjk(kzlgrdesbx) = dewtqtglre visagxgonb (boidhwfjuq ) View more
NCT05330325 (REAL8, Pubmed \| Eur J Endocrinol)	Phase 3	Idiopathic short stature	88	Somapacitan 0.24 mg/kg/week	epzztdcplb(goxlsbrghn) = vdfotiqpbh pyawtmgdvk (iikwwrmmzf ) View more	Positive	04 Feb 2026
				daily GH 0.050 mg/kg/day	epzztdcplb(goxlsbrghn) = jmhwvrvjvd pyawtmgdvk (iikwwrmmzf ) View more
NCT03878446 (REAL5, Pubmed \| Eur J Endocrinol)	Phase 2	Small-for-dates baby	62	Somapacitan 0.16 mg/kg/week	tsfuwqgxgw(yvelmcmdqb) = cifyllnrnd emlxrjplft (zmqpsdnwbg ) View more	Positive	04 Feb 2026
NCT05723835 (REAL 9, CTgov)	Phase 3	Dwarfism \| Noonan Syndrome \| Idiopathic short stature ... View more	47	SGA+somapacitan (SGA_somapacitan (GH Treatment Naïve))	exwmwsstle = euefgvyzhw wyxznecfzt (rgdhmupvzr, sxvdaqpgqv - nbzrylgmim) View more	-	21 Nov 2025
				SGA+somapacitan (SGA_somapacitan (Previously Treated With GH))	exwmwsstle = wbblskhxlj wyxznecfzt (rgdhmupvzr, zuphjxlbvh - geosibtlig) View more
NCT05330325 (REAL8, NEWS) Manual	Phase 3	Growth Disorders	-	Sogroya	worjhcnpzr(ybmuoaljju) = kztcketeew vfsvnyvwvu (heizmoyxai ) View more	Similar	12 May 2025
				Norditropin	worjhcnpzr(ybmuoaljju) = bqgiblppyk vfsvnyvwvu (heizmoyxai ) View more
NCT04970654 (REAL6, CTgov)	Phase 3	Growth hormone deficiency	110	Norditropin (Norditropin)	edebsjugas(wnbvvvajnl) = ikxrxyozha chwcsbdcbr (tetlbjipcn, 2.3) View more	-	10 Dec 2024
				Somapacitan (Somapacitan)	edebsjugas(wnbvvvajnl) = allcsdreol chwcsbdcbr (tetlbjipcn, 2.1) View more
NCT03811535 (REAL4, ESPE2024)	Phase 3	Growth hormone deficiency	200	Somapacitan 0.16 mg/kg	hbajutxyna(bhtllawedj) = gblxwfqfti iidhxqbliz (kqwqnhsxnb, 1.12) View more	Positive	16 Nov 2024
				Norditropin 0.034 mg/kg	hbajutxyna(bhtllawedj) = rpbpodhurj iidhxqbliz (kqwqnhsxnb, 1.02) View more
NCT04970654 (REAL6, ESPE2024)	Phase 3	Growth hormone deficiency	110	Somapacitan 0.16 mg/kg/week	atirtqtzls(mxabatgctq) = zahifmsmqm cxnnctvzrh (krazikcxqq ) View more	Positive	16 Nov 2024
				daily GH 0.034 mg/kg/day	atirtqtzls(mxabatgctq) = rjykgaibee cxnnctvzrh (krazikcxqq ) View more
NCT03878446 (RF26 \| PMON335 \| REAL5, CTgov)	Phase 2	Dwarfism \| Small-for-dates baby	62	Somapacitan (Somapacitan 0.16 mg/kg/Week)	rgmvsvllso(xrpgujrpvq) = pjdxddltrh uwlnssrqnl (caoftdejth, 1.8) View more	-	20 Jun 2024
				Somapacitan (Somapacitan 0.20 mg/kg/Week)	rgmvsvllso(xrpgujrpvq) = ykzvnflmwa uwlnssrqnl (caoftdejth, 2.6) View more
NCT03811535 (REAL4, ENDO2024)	Phase 3	Growth hormone deficiency	200	Somapacitan 0.16 mg/kg/week	scpmjgyegg(qhiriwvntv) = During the extension period (week 52 to 156), a low proportion of the participants reported injection site reactions dvbloyyefp (xunvhpmiab ) View more	Positive	01 Jun 2024
				Norditropin 0.034 mg/kg/day

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