New Drugs and Therapeutics Update: Sogroya® (somapacitan-beco) Injection

Prepared by Daniel Mak, MD; Edited by Neha Patel, DO

On February 27th, 2026, the FDA approved Sogroya® (somapacitan-beco) for three new pediatric indications. The therapy is now authorized for children aged 2.5 years and older with idiopathic short stature (ISS), small for gestational age (SGA) without catch-up growth by age 2 years, and growth failure associated with Noonan Syndrome (NS).1

For all three of these new indications (ISS, SGA, and NS), the recommended starting dosage of Sogroya® is 0.24 mg/kg based on actual body weight, administered once weekly. This applies to both treatment-naïve patients and those switching from a daily growth hormone (somatropin) treatment.2

The approvals were supported by the pivotal REAL8 study, a multi-center, randomized, open-label, active-comparator, phase 3 basket study conducted in growth hormone treatment-naïve, pre-pubertal pediatric patients and included three separate sub-studies for each of the new indications of ISS, SGA, or NS.2,3 The primary endpoint of the study was the mean annualized height velocity (AHV) at 52 weeks. The study achieved its primary endpoint by demonstrating that once-weekly Sogroya® (0.24 mg/kg/week) was non-inferior to once-daily somatropin across all three indications.

 

Indication Mean AHV (SOGROYA®) Comparator AHV (Daily Somatropin) Total Age Range (Mean) Treatment Arms & Dosing
Idiopathic Short Stature 10.2 cm/yr 10.5 cm/yr 88 2.8–10.8 yrs (mean 6.9) • Sogroya® 0.24 mg/kg/week (n=60)
• Somatropin 0.05 mg/kg/day (n=28)
Small for Gestational Age 11.0 cm/yr 9.4 cm/yr (0.035 mg/kg/day)

11.1 cm/yr (0.067 mg/kg/day)

 142 2.6–10.7 yrs (mean 5.5) • Sogroya® 0.24 mg/kg/week (n=70)
• Somatropin 0.035 mg/kg/day (n=37)
• Somatropin 0.067 mg/kg/day (n=35)
Noonan Syndrome 10.4 cm/yr 9.2 cm/yr 77 2.0–11.1 yrs (mean 6.2) • Sogroya® 0.24 mg/kg/week (n=49)
• Somatropin 0.05 mg/kg/day (n=28)

 

References:

  1. FDA approves Novo Nordisk’s Sogroya® as the first and only once-weekly, long-acting growth hormone for three additional pediatric indications [News Release]. Feb 2026.

https://www.novonordisk-us.com/media/news-archive/news-details.html?id=916507

  1. Sogroya prescribing information. https://www.novo-pi.com/sogroya.pdf
  2. Abuzzahab J, Dauber A, Højby M, et al. Somapacitan in children with idiopathic short stature: a randomized controlled phase 3 study. Eur J Endocrinol. 2026;194(2):242-253. doi:10.1093/ejendo/lvag027
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