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

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 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 ®

Important Safety Information

Do not use Sogroya ® if:

Before taking Sogroya ®, tell your healthcare provider about all of your medical conditions, including if you:

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 ®?

What are the possible side effects of Sogroya ®?

Sogroya ® may cause serious side effects, including:

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 https://www.novo-pi.com/sogroya.pdf

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

Media:

Liz Skrbkova (US)

+1 609 917 0632

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Ambre James-Brown (Global)

+45 3079 9289

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Investors:

Frederik Taylor Pitter (US)

+1 609 613 0568

[email protected]

Jacob Martin Wiborg Rode (Global)

+45 3075 5956

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Sina Meyer (Global)

+45 3079 6656

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Christoffer Sho Togo Tullin (Global)

+45 3079 1471

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Max Ung (Global)

+45 3077 6414

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Alex Bruce (Global)

+45 34 44 26 13

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References

Sogroya ® is a registered trademark of Novo Nordisk Health Care AG.

Novo Nordisk is a registered trademark of Novo Nordisk A/S.

SOURCE Novo Nordisk