Sogroya
Evidence Grade A — Regulatory approved. 82 published studies. 21 registered clinical trials.
Loading...
Somapacitan (sold as Sogroya) is a once-weekly growth hormone treatment — the first to be approved for both adults and children with growth hormone deficiency. It uses the same albumin-binding technology as semaglutide (Ozempic/Wegovy) to extend its duration in the body, replacing the need for daily growth hormone injections with a single weekly shot.
82 published studies: 53 human, 2 animal, 0 in-vitro, 25 reviews
Somapacitan is marketed as Sogroya (approved August 2020 for adult growth hormone deficiency; expanded April 2023 to paediatric growth hormone deficiency in children aged 2.5 years and older). It is the first once-weekly growth hormone approved for both adult and paediatric patients.
In adults, clinical trials showed improvements in body composition including reduced truncal fat. In children, growth rates were comparable to daily somatropin. The albumin-binding approach provides predictable drug levels with lower peak-to-trough variation than some other long-acting growth hormone technologies. Sogroya competes with somatrogon (Ngenla) in the growing once-weekly growth hormone market, with both products expected to gradually replace daily injections as the standard of care.
Somapacitan is a modified version of human growth hormone with an added molecular component that binds to albumin, a protein abundantly present in the blood. This albumin binding creates a circulating reservoir — only the unbound portion is active at any given time, providing sustained, controlled growth hormone exposure over a full week. This is the same albumin-binding pharmacological principle used in semaglutide to achieve once-weekly dosing.
In adults, clinical trials showed improvements in body composition including reduced abdominal fat. In children, growth rates were comparable to daily somatropin injections, confirming that weekly dosing does not compromise growth outcomes. The albumin-binding approach provides predictable drug levels with lower variation between peak and trough than some competing technologies. Sogroya competes with somatrogon (Ngenla) in the growing once-weekly growth hormone market, and both are expected to gradually replace daily injections as the standard of care. Sogroya currently has the broader approval (adults and children), while Ngenla is approved only for children. Head-to-head data between the two products are not available. The REAL trial programme is being extended to additional growth conditions.
A Study to Follow Paediatric Participants With Growth Hormone Deficiency Treated With Somapacitan for Long Term Safety Information and Clinical Parameters
Growth Hormone for the Treatment of Gastroparesis
Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due to Growth Hormone Deficiency Where Epiphysial Discs Are Not Closed
A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information
A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
FDA ORIG 1
EMA Marketing Authorisation
FDA SUPPL 2
FDA SUPPL 1
FDA SUPPL 5
Health Canada Market Authorisation
FDA SUPPL 6
FDA SUPPL 13
FDA SUPPL 15
FDA SUPPL 14
FDA SUPPL 12
Somatropin has been available since the mid-1980s and is one of the most established peptide therapies. It is sold under numerous brand names including Genotropin, Humatrope, Norditropin, and Omnitrope (the first biosimilar approved in the US, 2006). Approved indications include childhood and adult growth hormone deficiency, Turner syndrome, children born small for gestational age, Prader-Willi syndrome, idiopathic short stature, and short stature from chronic kidney disease. Daily injection has been the main burden of somatropin therapy, particularly for paediatric patients who may require years of treatment. This has driven the development of once-weekly alternatives (somatrogon and somapacitan), which are gradually changing the treatment landscape. Annual treatment costs remain substantial, and concerns about misuse in anti-ageing and performance enhancement contexts are ongoing.
Tesamorelin is marketed as Egrifta SV (approved November 2010) for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. In clinical trials, it reduced visceral fat by approximately 15% compared to a 5% increase with placebo, and this reduction was sustained with continued treatment. Tesamorelin occupies a unique niche — it is the only approved GHRH analogue and the only medication specifically approved for HIV-associated lipodystrophy. Beyond its approved indication, it has attracted research interest for potential effects on liver fat, cognitive function, and peripheral neuropathy. Fat reduction reverses when treatment stops, and it is not approved for general weight loss or body composition purposes.
Somatrogon is marketed as Ngenla (approved June 2023) for paediatric growth hormone deficiency in children aged 3 years and older. In the pivotal trial, once-weekly somatrogon produced growth rates equivalent to daily somatropin injections (10.1 cm/year versus 9.8 cm/year), confirming that reducing injection frequency does not compromise growth outcomes. Ngenla represents a meaningful advance for paediatric patients and their families, reducing injections from 365 to 52 per year. Treatment adherence has been a persistent challenge with daily growth hormone, and weekly dosing is expected to improve long-term outcomes through better compliance. Somatrogon competes directly with somapacitan (Sogroya), the other approved weekly growth hormone, creating a new generation of less burdensome treatment options.
