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
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
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.
ACE-031 has no marketing authorisation. A Phase I trial in healthy women showed increased lean mass and decreased fat mass. A Phase II trial in DMD (24 patients) showed lean body mass increases but was discontinued due to bleeding-related safety concerns (epistaxis, telangiectasias, and gum bleeding), likely caused by inhibition of BMP-9/10 vascular signalling. ACE-031 is a large fusion protein (~90 kDa), not a peptide. Its clinical development was halted. The non-selective ligand-trapping profile — capturing beneficial vascular signalling molecules alongside the intended muscle-growth targets — illustrates the challenge of targeting the TGF-beta superfamily. Acceleron subsequently developed more selective agents.
PEG-MGF has no marketing authorisation. No peer-reviewed studies of PEG-MGF as a defined PEGylated peptide entity exist. The PEG chain length, attachment site, and resulting pharmacological properties are not standardised. The absence of any characterisation studies means that products sold as PEG-MGF through unregulated channels have no defined molecular identity, no quality standards, and no basis for predicting their behaviour. This compound represents one of the least-characterised entries in this database.
Evidence Reviews
Timelines
Regulatory Status
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