Evidence Grade A — Regulatory approved. 83 published studies. 6 registered clinical trials.
Medically reviewed by a licensed medical professional
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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.
Somapacitan is also known by these brand and alternate names:
83 published studies: 54 human, 2 animal, 0 in-vitro, 27 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.
PeptideTrace tracks 6 registered clinical trials for Somapacitan sourced from ClinicalTrials.gov.
A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy Subjects
Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function.
Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function
A Trial Investigating the Absorption, Metabolism and Excretion of Somapacitan After Single Dosing in Healthy Male Subjects
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EMA Marketing Authorisation
FDA SUPPL 2
FDA SUPPL 1
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Health Canada Market Authorisation
FDA SUPPL 6
FDA SUPPL 13
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FDA SUPPL 12
Somapacitan is a long-acting growth hormone derivative created by introducing a single amino acid substitution (L101C) in the GH molecule and attaching an albumin-binding moiety at that position. This enables non-covalent albumin binding in the circulation, extending the half-life and enabling once-weekly dosing. Developed by Novo Nordisk.
Somapacitan activates the GH receptor via JAK2-STAT5 signaling, identical to native GH. The albumin-binding moiety creates a circulating reservoir—only unbound somapacitan is active, providing sustained, controlled GH exposure over the weekly dosing interval. This is the same albumin-binding pharmacological principle used in semaglutide (GLP-1) and insulin degludec.
Somapacitan is marketed as Sogroya (FDA approved August 28, 2020 for adult GHD; April 28, 2023 expanded to pediatric GHD aged ≥2.5 years). It is the first once-weekly GH approved for both adults and children. REAL 1 (N=301 adults): somapacitan produced significant reductions in truncal fat (−1.06% vs +0.47% placebo). REAL 4 (N=200 children): height velocity 11.2 cm/year versus 11.7 cm/year (daily GH), meeting noninferiority.
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.
MGF has no marketing authorisation. No human clinical trials have been conducted. The evidence base consists of animal studies and cell culture experiments. A single mouse study reported increased muscle fibre size after intramuscular injection. The compound's very short half-life (estimated minutes) in its native form has led to the development of PEGylated versions (PEG-MGF, #105) in unregulated channels, though this creates a pharmacologically distinct molecule. Products available through unregulated channels lack pharmaceutical quality assurance.
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.
Evidence Reviews
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Regulatory Status
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