Approved & therapeutic
Somatrogon
Ngenla
Somatrogon is a long-acting human growth hormone analog given once weekly. It is FDA approved for growth failure due to inadequate endogenous growth hormone secretion in children aged 3 years and older, and is not approved in the United States for adults.
- Status
- Somatrogon is approved by the U.S. FDA and has official prescribing information.
- Evidence
- Approved labeling. Official prescribing information exists, based on clinical trials in people.
- Half-life
- Mean population-pharmacokinetic estimated effective half-life of approximately 37.7 hours in pediatric patients, consistent with once-weekly dosing. This is a modelled effective half-life, not a directly measured terminal half-life, and it varies with body weight.
- How it's taken
- Subcutaneous injection
- Mechanism
- Anabolic (IGF-1 / myostatin)
- Pathways
- GH axis, IGF-1
How Somatrogon works
Somatrogon is human growth hormone fused to three copies of the C-terminal peptide of the beta chain of human chorionic gonadotropin, which slows clearance and extends the dosing interval. It binds the growth hormone receptor and activates STAT5b signalling, raising insulin-like growth factor 1 and driving linear growth and the associated metabolic effects.
What research has looked at
- In its phase 3 registration trial in treatment-naive children with growth hormone deficiency, once-weekly somatrogon met the primary endpoint of non-inferior annual height velocity at 12 months compared with once-daily somatropin.
- Raises insulin-like growth factor 1 concentrations in children with growth hormone deficiency.
- Extension data reported continued height velocity and no new safety signals over three years of treatment.
- Once-weekly dosing reduces injection frequency compared with daily growth hormone.
Evidence level: Approved labeling. Official prescribing information exists, based on clinical trials in people. These are areas studied or reported, not promised effects.
Reported side effects and risks
- Contraindicated in patients with known hypersensitivity to somatrogon or any of its excipients; severe hypersensitivity reactions including anaphylaxis have been reported.
- Contraindicated in acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or in acute respiratory failure, because of increased mortality.
- Contraindicated in active malignancy, in closed epiphyses, in active proliferative or severe non-proliferative diabetic retinopathy, and in Prader-Willi syndrome with severe obesity, a history of upper airway obstruction or sleep apnea, or severe respiratory impairment, where sudden death has been reported.
- Increased risk of neoplasms, including second neoplasms in childhood cancer survivors.
- Glucose intolerance and diabetes mellitus, intracranial hypertension, and fluid retention.
- Hypoadrenalism, hypothyroidism, and pancreatitis.
- Slipped capital femoral epiphysis and progression of preexisting scoliosis in children; lipoatrophy at injection sites.
- Requires laboratory monitoring: thyroid function, glucose and HbA1c, IGF-1 levels, and cortisol in patients with or at risk of hypoadrenalism.
- Commonly reported reactions (at least 5 percent) include injection site reactions, nasopharyngitis, headache, pyrexia, anemia, cough, vomiting, hypothyroidism, abdominal pain, rash and oropharyngeal pain. Injection site reactions were reported more frequently with somatrogon than with daily somatropin in the comparative trial (42.2 percent versus 25.2 percent). There is no US-approved adult indication; adult use would be off-label.
Sources
- PubMed research on Somatrogon · NIH · National Library of Medicine
- DrugBank record for Somatrogon · DrugBank
- Active clinical trials for Somatrogon · U.S. National Library of Medicine
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Somatrogon FAQ
What is Somatrogon?
Somatrogon is a long-acting human growth hormone analog given once weekly. It is FDA approved for growth failure due to inadequate endogenous growth hormone secretion in children aged 3 years and older, and is not approved in the United States for adults.
How does Somatrogon work?
Somatrogon is human growth hormone fused to three copies of the C-terminal peptide of the beta chain of human chorionic gonadotropin, which slows clearance and extends the dosing interval. It binds the growth hormone receptor and activates STAT5b signalling, raising insulin-like growth factor 1 and driving linear growth and the associated metabolic effects.
Is Somatrogon FDA approved?
Yes. Somatrogon is approved by the U.S. FDA and has official prescribing information. Evidence level: approved labeling. Official prescribing information exists, based on clinical trials in people.
What is the half-life of Somatrogon?
Reported half-life: Mean population-pharmacokinetic estimated effective half-life of approximately 37.7 hours in pediatric patients, consistent with once-weekly dosing. This is a modelled effective half-life, not a directly measured terminal half-life, and it varies with body weight.
How is Somatrogon taken?
Subcutaneous injection.
What side effects have been reported with Somatrogon?
Reported in the sources: Contraindicated in patients with known hypersensitivity to somatrogon or any of its excipients; severe hypersensitivity reactions including anaphylaxis have been reported; Contraindicated in acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or in acute respiratory failure, because of increased mortality; Contraindicated in active malignancy, in closed epiphyses, in active proliferative or severe non-proliferative diabetic retinopathy, and in Prader-Willi syndrome with severe obesity, a history of upper airway obstruction or sleep apnea, or severe respiratory impairment, where sudden death has been reported; Increased risk of neoplasms, including second neoplasms in childhood cancer survivors; Glucose intolerance and diabetes mellitus, intracranial hypertension, and fluid retention; Hypoadrenalism, hypothyroidism, and pancreatitis; Slipped capital femoral epiphysis and progression of preexisting scoliosis in children; lipoatrophy at injection sites; Requires laboratory monitoring: thyroid function, glucose and HbA1c, IGF-1 levels, and cortisol in patients with or at risk of hypoadrenalism; Commonly reported reactions (at least 5 percent) include injection site reactions, nasopharyngitis, headache, pyrexia, anemia, cough, vomiting, hypothyroidism, abdominal pain, rash and oropharyngeal pain. Injection site reactions were reported more frequently with somatrogon than with daily somatropin in the comparative trial (42.2 percent versus 25.2 percent). There is no US-approved adult indication; adult use would be off-label.
Educational summary compiled from the sources listed above. Not medical advice. Peptide Vault does not sell, source or recommend any compound. Talk to a qualified clinician before starting or changing anything.