Hormone · FDA Approved
Somapacitan (Sogroya)
FDA-approved
01 · Overview
Somapacitan is a long-acting growth hormone derivative engineered to bind reversibly to albumin, which extends its half-life to allow once-weekly subcutaneous administration instead of the daily injections required for standard somatropin (PMID 32022863).
The molecule retains growth hormone receptor agonist activity, with the longer action intended to reduce treatment burden and improve adherence.
02 · Research summary & key findings
The phase 3 REAL 1 trial in 301 treatment-naive adults with growth hormone deficiency showed once-weekly somapacitan reduced truncal fat percentage versus placebo, with benefits and safety similar to daily growth hormone over 86 weeks (PMID 32022863). A separate 52-week phase 3 trial in previously treated Japanese adults found safety and efficacy similar to daily growth hormone (PMID 32603494). The FDA approved somapacitan in August 2020 as the first once-weekly growth hormone therapy for adults with growth hormone deficiency (PMID 36305544).
03 · Regulatory status
Somapacitan (Sogroya) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.
Somapacitan (Sogroya) is an FDA-approved medicine prescribed for the conditions on its label. It is not part of our intake, so we do not propose protocols for it. If you think it may be relevant to you, talk to your own doctor. How to ask your doctor.
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04 · Administration routes
- Subcutaneous injection
References
- [1]Once-weekly Somapacitan is Effective and Well Tolerated in Adults with GH Deficiency: A Randomized Phase 3 Trial J Clin Endocrinol Metab, 2020. PMID 32022863
- [2]Similar safety and efficacy in previously treated adults with growth hormone deficiency randomized to once-weekly somapacitan or daily growth hormone Clin Endocrinol (Oxf), 2020. PMID 32603494
- [3]Somapacitan: a long-acting growth hormone derivative for treatment of growth hormone deficiency Drugs Today (Barc), 2022. PMID 36305544
Primary literature
- PubMed: "Somapacitan"
Peer-reviewed literature indexed by the National Library of Medicine.
- ClinicalTrials.gov: "Somapacitan"
Registered interventional and observational studies, including status and phase.
- PubChem: "Somapacitan"
Chemical structure, molecular properties, and bioactivity data.
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