Evidence Grade A — Regulatory approved. 63 published studies. 1 registered clinical trial.
Medically reviewed by a licensed medical professional
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Somatrogon (sold as Ngenla) is a once-weekly growth hormone injection for children with growth hormone deficiency — reducing the injection burden from 365 times per year to 52. For children who may need years of treatment, this represents a significant improvement in daily quality of life and treatment adherence.
Somatrogon is also known by these brand and alternate names:
63 published studies: 34 human, 0 animal, 0 in-vitro, 26 reviews
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.
Somatrogon works through the same growth hormone receptor as the body's natural growth hormone and as daily somatropin. The difference is in its molecular design: human growth hormone has been fused with segments from another hormone (hCG) that contain sugar-coated attachment points. These sugar molecules prevent the kidneys from clearing the drug quickly, extending its duration from hours to about a week. The result is sustained growth hormone activity from a single weekly injection.
The pivotal trial showed that once-weekly somatrogon produced growth rates equivalent to daily somatropin (10.1 cm/year versus 9.8 cm/year), confirming that reducing injection frequency does not sacrifice growth outcomes. Treatment adherence has been a persistent challenge with daily growth hormone injections, and weekly dosing is expected to improve long-term outcomes. Ngenla is currently approved only for paediatric growth hormone deficiency (not adults), whereas the competing weekly product somapacitan (Sogroya) covers both adults and children. The paediatric growth hormone market is now actively transitioning from daily to weekly formulations. Long-term safety surveillance and potential expansion to other growth conditions (Turner syndrome, children born small for gestational age) are ongoing.
PeptideTrace tracks 1 registered clinical trial for Somatrogon sourced from ClinicalTrials.gov.
A Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations
EMA Marketing Authorisation
Health Canada Market Authorisation
FDA ORIG 1
FDA SUPPL 1
FDA SUPPL 3
FDA SUPPL 6
Somatrogon is a long-acting growth hormone consisting of human GH fused with three copies of the C-terminal peptide (CTP) domain from the β-subunit of human chorionic gonadotropin (hCG)—one N-terminal and two C-terminal copies. The CTP domains contain O-linked glycosylation sites that extend the half-life.
Somatrogon activates the GH receptor via the same JAK2-STAT5 signaling pathway as native GH. The CTP-mediated glycosylation reduces renal clearance and extends the circulating half-life to approximately 28.3 hours, enabling once-weekly subcutaneous dosing (versus daily for somatropin). Produced in CHO cells. Developed by OPKO Health with Pfizer.
Somatrogon is marketed as Ngenla (FDA approved June 27, 2023) for pediatric growth hormone deficiency in patients aged 3 years and older. In the pivotal trial (N=224), once-weekly somatrogon produced a height velocity of 10.12 cm/year versus 9.78 cm/year for daily somatropin, meeting the noninferiority primary endpoint. The once-weekly dosing significantly reduces injection burden for pediatric patients.
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.
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.
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