Hormones & metabolism Long-acting GH analog
Somapacitan
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- Also known as
- Sogroya
- FDA approval
- An FDA-approved product contains this peptide
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Somapacitan (sold as Sogroya) is a long-acting form of growth hormone engineered for once-weekly dosing, used to replace growth hormone in children and adults who do not make enough. It attaches reversibly to the body's own albumin to slow its clearance, so one injection a week replaces the daily injections of standard growth hormone. It has been FDA-approved in the U.S. since 2020 and is given once weekly under the skin.
At a glance
- What it is
- A long-acting (once-weekly) growth hormone derivative
- Approved for
- Growth hormone deficiency in adults and children, and three other causes of short stature in children
- Key fact
- In the REAL 1 trial it reduced truncal fat in adults with growth hormone deficiency, comparable to daily growth hormone
- Route
- Subcutaneous injection, once weekly
- Evidence strength
- FDA approved
Summary
Somapacitan is a long-acting growth hormone, FDA-approved since 2020, given once weekly. Learn how it works, who it is for, and how it differs from daily doses.
What is somapacitan?
Somapacitan, sold under the brand Sogroya, is a modified version of human growth hormone designed to last much longer in the body than natural or standard recombinant growth hormone. A small fatty-acid side chain lets it bind reversibly to albumin, the most abundant protein in blood, which shields it from rapid clearance and stretches its action out to a full week. It was developed under the code NNC0195-0092 and approved in the United States in 2020.
How does somapacitan work?
Somapacitan activates the growth hormone receptor just as natural growth hormone does, stimulating the liver and other tissues to produce insulin-like growth factor 1 (IGF-1) and driving the metabolic and growth effects of the hormone. Its single amino-acid change and attached albumin-binding moiety do not change what it does at the receptor; they change how long it circulates. By binding albumin reversibly, the drug is released gradually, maintaining growth hormone activity across the week between doses.
For adults with growth hormone deficiency, restoring growth hormone improves body composition, reducing fat and supporting lean mass; for children who do not make enough growth hormone, it supports linear growth. In the REAL 1 trial in adults, once-weekly somapacitan significantly reduced truncal fat compared with placebo and performed comparably to daily growth hormone. The weekly schedule is the practical advantage over conventional daily injections.
Is it FDA-approved?
Editor’s note
Status: Yes. Somapacitan was approved by the FDA in 2020, and its approved uses have grown since: Date | Approved use added 2020 | Adults with growth hormone deficiency 2023 | Pediatric growth hormone deficiency February 2026 | Idiopathic short stature in children 2.5 and older February 2026 | Short stature in children 2.5 and older born small for gestational age February 2026 | Growth failure from Noonan syndrome in children 2.5 and older It is given as a once-weekly subcutaneous injection.
Category: FDA-approved · Primary body area: Hormones & metabolism
Yes. Somapacitan was approved by the FDA in 2020, and its approved uses have grown since:
| Date | Approved use added |
|---|---|
| 2020 | Adults with growth hormone deficiency |
| 2023 | Pediatric growth hormone deficiency |
| February 2026 | Idiopathic short stature in children 2.5 and older |
| February 2026 | Short stature in children 2.5 and older born small for gestational age |
| February 2026 | Growth failure from Noonan syndrome in children 2.5 and older |
It is given as a once-weekly subcutaneous injection.
What is somapacitan prescribed for?
Somapacitan is prescribed to replace growth hormone in adults with growth hormone deficiency and in children 2.5 and older with growth failure due to inadequate growth hormone secretion. In children it is also prescribed for idiopathic short stature, short stature after being born small for gestational age, and growth failure associated with Noonan syndrome. The weekly dosing is often chosen to reduce the burden of daily injections.
What are the side effects?
According to the prescribing information, common side effects in adults include:
- Back pain and joint pain
- Indigestion and vomiting
- Sleep problems and dizziness
- Swelling in the hands and feet
- High blood pressure and weight gain
- Tonsillitis, anemia, and low cortisol levels
Common side effects in children include:
- Cold symptoms, cough, and respiratory or ear infections
- Fever and headache
- Diarrhea and vomiting
- Injection-site reactions
- Pain in the arms or legs
More serious considerations include:
- Fluid retention and reduced insulin sensitivity, shared with the growth hormone class
- The need to monitor for the growth hormone class risks, including effects on glucose and, with any growth hormone, caution in active cancer
- Increased pressure around the brain (intracranial hypertension), which is rare
- Serious allergic reactions
Sources: FDA prescribing information for Sogroya; the REAL 1 trial (Johannsson et al., The Journal of Clinical Endocrinology & Metabolism, 2020, DOI: 10.1210/clinem/dgaa049), indexed on PubMed. This document is educational and does not constitute medical advice.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
approved (PDF)
Compare every peptide’s status in the peptide regulatory status database
More for Hormones & metabolism
View all hormones & metabolism peptides →- FDA-approved Hormones & metabolism
Albiglutide
Albiglutide is a once-weekly GLP-1 receptor agonist made by fusing GLP-1 analog chains to human albumin, approved for type 2 diabetes in 2014 as Tanzeum. It had a somewhat weaker effect on gastric emptying and appetite than some other GLP-1 drugs but showed a cardiovascular benefit in the HARMONY OUTCOMES trial. Despite that, GSK withdrew it from the market in 2018 for commercial reasons, so it remains FDA-approved but is no longer available.
- Not FDA-approved Hormones & metabolism
Compounded-Tesamorelin
Tesamorelin is an FDA-approved growth-hormone-releasing peptide, sold as Egrifta, for excess abdominal fat in HIV-associated lipodystrophy. In a randomized trial of 404 people with HIV (Falutz 2010), visceral fat fell 10.9% on tesamorelin versus 0.6% on placebo over 6 months. Its off-label use for body composition and anti-aging in people without HIV is not an approved indication and lacks dedicated trials. It is banned in sport.
- FDA-approved Hormones & metabolism
Corticotropin
ACTH
Corticotropin (adrenocorticotropic hormone, or ACTH; sold as Acthar Gel and Purified Cortrophin Gel) is a hormone preparation that stimulates the adrenal glands to make their own steroids and also acts directly on immune cells. It is one of the oldest biologic medicines, used today for conditions ranging from infantile spasms to multiple sclerosis relapses. It has been FDA-approved in the U.S. since 1952 and is given as a long-acting injection.
- FDA-approved Hormones & metabolism
Cosyntropin
Cosyntropin (sold as Cortrosyn) is a synthetic fragment of adrenocorticotropic hormone used as a diagnostic agent to test whether the adrenal glands are working. A dose is given and the resulting rise in cortisol shows how well the adrenals respond. It has long been FDA-approved in the U.S. and is given as a single injection during the test.
- FDA-approved Hormones & metabolism
Dulaglutide
Dulaglutide is a once-weekly GLP-1 receptor agonist built by fusing two GLP-1 analog chains to an antibody fragment, which extends its action to about five days. It was approved for type 2 diabetes in 2014 and gained a cardiovascular indication in 2020 after the REWIND trial showed a roughly 12% reduction in major cardiovascular events. It remains on the market as Trulicity.
- In clinical trials Hormones & metabolism
Efpeglenatide
Efpeglenatide is an investigational long-acting GLP-1 receptor agonist, originally developed by Hanmi Pharmaceutical, given as a once-weekly injection for type 2 diabetes and cardiovascular risk. In a large Phase 3 outcomes trial it reduced major cardiovascular events in people with type 2 diabetes. As of 2026, it has not reached approval in major markets.