Approved & therapeutic
Somapacitan
Sogroya
Somapacitan is a long-acting human growth hormone derivative given once weekly. It is FDA approved for growth hormone deficiency in adults and for several causes of growth failure in children.
- Status
- Somapacitan 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
- Approximately 2 to 3 days in adults with growth hormone deficiency and roughly 34 to 37 hours in pediatric patients, consistent with once-weekly dosing. The label reports these as ranges rather than single figures.
- How it's taken
- Subcutaneous injection
- Mechanism
- Anabolic (IGF-1 / myostatin)
- Pathways
- GH axis, IGF-1
How Somapacitan works
Somapacitan binds and activates the dimeric growth hormone receptor, producing the same intracellular signalling as endogenous growth hormone. An albumin-binding side chain causes reversible binding to circulating albumin, which slows elimination and extends the duration of action enough to allow weekly dosing.
What research has looked at
- In a phase 3 trial in treatment-naive adults with growth hormone deficiency, once-weekly somapacitan reduced truncal fat percentage at week 34 compared with placebo, the trial's primary endpoint.
- In the phase 3 REAL 4 trial in treatment-naive children with growth hormone deficiency, annualised height velocity at 52 weeks was non-inferior to daily somatropin.
- Raises insulin-like growth factor 1 into the target range in people with growth hormone deficiency.
- Also approved for growth failure in children born small for gestational age, children with Noonan syndrome, and idiopathic short stature.
- Once-weekly administration reduces injection frequency compared with daily growth hormone. The label's active comparator arm of daily somatropin was not powered as a superiority comparison and is not presented as one.
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 acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or in acute respiratory failure, because of increased mortality.
- Contraindicated in known hypersensitivity to somapacitan or any of its excipients. Systemic hypersensitivity reactions have been reported postmarketing with somatropin.
- Contraindicated in active malignancy, in active proliferative or severe non-proliferative diabetic retinopathy, in children with closed epiphyses, and in children with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment, because of a risk of sudden death.
- Glucose intolerance and diabetes mellitus, intracranial hypertension, and fluid retention with peripheral edema.
- Unmasking of hypoadrenalism, hypothyroidism, and pancreatitis; increased risk of neoplasms, including progression of a preexisting malignancy and a second neoplasm in childhood cancer survivors treated with radiation to the brain or head.
- Slipped capital femoral epiphysis and progression of preexisting scoliosis in children; lipohypertrophy or lipoatrophy at injection sites; growth hormone can alter thyroid function and other laboratory test results.
- Severe hypersensitivity reactions. Commonly reported reactions include nasopharyngitis, headache, pyrexia, pain in extremity and injection site reactions in children, and back pain, arthralgia, dyspepsia, sleep disorder, dizziness and peripheral edema in adults. There is no boxed warning on the US label.
Sources
- PubMed research on Somapacitan · NIH · National Library of Medicine
- DrugBank record for Somapacitan · DrugBank
- Active clinical trials for Somapacitan · U.S. National Library of Medicine
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Somapacitan FAQ
What is Somapacitan?
Somapacitan is a long-acting human growth hormone derivative given once weekly. It is FDA approved for growth hormone deficiency in adults and for several causes of growth failure in children.
How does Somapacitan work?
Somapacitan binds and activates the dimeric growth hormone receptor, producing the same intracellular signalling as endogenous growth hormone. An albumin-binding side chain causes reversible binding to circulating albumin, which slows elimination and extends the duration of action enough to allow weekly dosing.
Is Somapacitan FDA approved?
Yes. Somapacitan 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 Somapacitan?
Reported half-life: Approximately 2 to 3 days in adults with growth hormone deficiency and roughly 34 to 37 hours in pediatric patients, consistent with once-weekly dosing. The label reports these as ranges rather than single figures.
How is Somapacitan taken?
Subcutaneous injection.
What side effects have been reported with Somapacitan?
Reported in the sources: 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 known hypersensitivity to somapacitan or any of its excipients. Systemic hypersensitivity reactions have been reported postmarketing with somatropin; Contraindicated in active malignancy, in active proliferative or severe non-proliferative diabetic retinopathy, in children with closed epiphyses, and in children with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment, because of a risk of sudden death; Glucose intolerance and diabetes mellitus, intracranial hypertension, and fluid retention with peripheral edema; Unmasking of hypoadrenalism, hypothyroidism, and pancreatitis; increased risk of neoplasms, including progression of a preexisting malignancy and a second neoplasm in childhood cancer survivors treated with radiation to the brain or head; Slipped capital femoral epiphysis and progression of preexisting scoliosis in children; lipohypertrophy or lipoatrophy at injection sites; growth hormone can alter thyroid function and other laboratory test results; Severe hypersensitivity reactions. Commonly reported reactions include nasopharyngitis, headache, pyrexia, pain in extremity and injection site reactions in children, and back pain, arthralgia, dyspepsia, sleep disorder, dizziness and peripheral edema in adults. There is no boxed warning on the US 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.