Somapacitan
Long-acting GH analog
Also Sogroya, Somapacitan-beco, NNC0195-0092, Sogroya injection, Long-acting growth hormone
- Evidence
- AStrong human evidence
- FDA status
- FDA approvedas of 2026-10-26
- Route
- Injection
- Studies cited
- 2 human0 animal or cell
A once-a-week growth hormone shot that replaces daily shots. Controlled trials show it works as well as daily doses.
Sold for
Somapacitan is the once-a-week growth hormone that replaces daily injections for children and adults who lack the hormone.
Studies say
Randomized trials show weekly somapacitan reduces body fat in adults with growth hormone deficiency as well as daily growth hormone does and produces equivalent growth in children, which supports an A for its approved uses.
Why grade A. The adult approval rested on REAL 1, a randomized, double-blind, placebo-controlled and active-controlled trial of 301 adults with growth hormone deficiency, and the pediatric approvals on randomized trials against daily somatropin, the most recent being the REAL8 basket trial across three indications. The question these trials answer is whether weekly somapacitan matches daily growth hormone, and they show it does. 13
FDA. Somapacitan is FDA-approved as Sogroya (Novo Nordisk), a once-weekly injection, for adults with growth hormone deficiency (August 2020), children aged 2.5 and older with growth hormone deficiency (2023), and, since February 27, 2026, children aged 2.5 and older with idiopathic short stature, short stature after being born small for gestational age, or growth failure from Noonan syndrome. 23
Written from 3 cited sources. Fact-checked 2026-10-27: 16 claims checked, 2 corrected. Last refreshed 2026-10-27. Not physician reviewed.
What this means for you
- What people take it for
- Growth hormone shortage in adults and children
- Can a US doctor prescribe it?
- Yes, FDA approved for growth hormone shortage in adults and children, and some short stature in children.
- Properly tested in people?
- Yes, in large controlled trials; one covered 301 adults.
Evidence checklist
- Randomised controlled trial REAL 1 and pediatric randomized trialsyes
- Human study over 100 people REAL 1 enrolled 301 adultsyes
- More than one research group Trials run by Novo Nordiskno information
- Clinical outcomes, not surrogate markers Height velocity, body fatno
- Human safety data beyond case reports Trial and label safety datayes
Drawn from the cited studies below. A dash means the sources give no information.
What it is
Somapacitan is human growth hormone with one amino acid changed. The change lets a small side chain attach. That side chain binds reversibly to albumin, the most common protein in blood. This keeps the hormone in the blood for about a week instead of hours. Otherwise the hormone is identical to the body's own growth hormone, which has 191 amino acids. 12
Daily growth hormone injections have been standard since the 1980s. Missed doses are common, especially in teenagers. Several long-acting versions now exist. Somapacitan was the first weekly growth hormone approved for adults in the United States. As of 2026, it is the only one approved for idiopathic short stature, small-for-gestational-age short stature and Noonan syndrome. 23
How it works
Growth hormone binds receptors on the liver and other tissues. This drives production of IGF-1. In children, it drives growth. In adults, it maintains muscle, bone and normal body fat distribution. Adults with growth hormone deficiency gain fat around the trunk and lose lean mass. Somapacitan acts on the same receptor as native growth hormone. Albumin binding slows its clearance. So one injection keeps IGF-1 in the normal range for a week. IGF-1 levels rise and fall across the week. So the trials tracked peak values to avoid overexposure. 12
What human research shows
REAL 1 enrolled 301 adults with growth hormone deficiency who had not been treated before. Researchers randomized them to weekly somapacitan, daily somatropin, or weekly placebo for 34 weeks. The main measure was change in truncal fat percentage. It fell 1.06 percentage points with somapacitan and rose 0.47 points with placebo. That difference was significant. The change was similar to that with daily somatropin. Lean mass, visceral fat and IGF-1 moved in the expected directions. A 52-week extension brought total treatment to 86 weeks. The gains held on both somapacitan and daily growth hormone. 1
In children, randomized trials against daily somatropin showed equivalent height velocity in growth hormone deficiency. REAL8 was a basket trial in prepubertal children who had not been treated before. They had idiopathic short stature, small-for-gestational-age short stature or Noonan syndrome. It met its main goal of non-inferior height velocity at 52 weeks in all three groups. Children and parents in these trials generally preferred the weekly schedule. 23
| Study | Model | Finding |
|---|---|---|
| REAL 1 | Humans, n=301 adults with growth hormone deficiency, randomized, double-blind placebo arm and open-label somatropin arm, 34 weeks | Truncal fat fell with somapacitan and rose with placebo; effects matched daily somatropin. 1 |
| REAL8 basket trial | Humans, treatment-naive prepubertal children across three indications, randomized versus daily somatropin, 52 weeks | Weekly somapacitan was non-inferior to daily growth hormone for height velocity in idiopathic short stature, small-for-gestational-age and Noonan syndrome. 3 |
| Sogroya prescribing information | FDA label | Summarizes pediatric growth hormone deficiency trials and adverse reaction data across indications. 2 |
Safety
Side effects match those of growth hormone in general. They include headache, joint and muscle pain, and swelling from fluid retention. Adults may get carpal tunnel symptoms. These came mostly early in treatment and depended on the dose. Injection site reactions were mild. Growth hormone raises blood glucose and can unmask diabetes, so doctors monitor glucose. The label carries the class warnings. People with active cancer or acute critical illness should not use it. Children with Prader-Willi syndrome who are severely obese or have severe breathing problems should not use it. Doctors should watch for slipped hip growth plates and worsening scoliosis in growing children. Anti-drug antibodies were rare and did not neutralize the hormone. Daily growth hormone has a four-decade safety record in children, and long-term pediatric safety follows it. But weekly dosing produces higher peak IGF-1 than daily dosing. Whether that matters over decades is not yet known. 12
Questions for your clinician
- Is weekly dosing as effective as daily for my situation?
- How is my blood glucose monitored during treatment?
- Are long-term outcomes known beyond the trials?
Questions people ask
How is somapacitan different from regular growth hormone?
The hormone is the same. A small side chain on one amino acid lets it stick to albumin in the blood, so it lasts about a week. The result is one injection weekly instead of daily. In randomized trials, effects were similar on body composition in adults and growth in children. 12
Is it approved for adults who want more muscle or less fat?
No. It is approved for adults with diagnosed growth hormone deficiency, confirmed by stimulation testing. REAL 1 saw less trunk fat in people who lacked the hormone. Somapacitan trials in healthy adults give no evidence. The label warns against use without deficiency. 12
What did the February 2026 approval add?
There are three pediatric approved uses beyond growth hormone deficiency. One is idiopathic short stature. One is short stature in children born small for gestational age who have not caught up by age 2. One is growth failure from Noonan syndrome. All are for children aged 2.5 and older. They rest on the REAL8 trial. It showed weekly somapacitan grew children as well as daily somatropin. 3
Which adverse reactions are typical?
The common ones are headache, joint and muscle pain, fluid retention and injection site reactions. Glucose can rise. The label carries growth hormone's standard warnings about cancer, critical illness and Prader-Willi syndrome. The open question with weekly products is whether higher weekly IGF-1 peaks have long-term consequences. 12
Citations
- Johannsson 2020, J Clin Endocrinol Metab: once-weekly somapacitan vs daily GH in adults with GH deficiency (REAL 1) pubmed.ncbi.nlm.nih.gov
- Sogroya (somapacitan-beco) prescribing information, Novo Nordisk novo-pi.com
- HCPLive, Feb 2026: FDA approves three new pediatric indications for somapacitan (REAL8) hcplive.com