In short
Somatrogon is a long-acting human growth hormone used to treat growth failure caused by growth hormone deficiency in children. It is a man-made version of the growth hormone naturally produced by the pituitary gland. In the EU Clinical Trials Information System, one Phase 3 trial is currently authorised, comparing weekly somatrogon with daily Genotropin in 245 children born small for gestational age or with idiopathic short stature.
Key points
- Somatrogon is a long-acting growth hormone given once weekly by subcutaneous injection.
- It is authorised as the medicine Ngenla for treating growth failure caused by growth hormone deficiency.
- The authorised Phase 3 trial includes 245 children born small for gestational age or with idiopathic short stature.
- The trial compares weekly somatrogon with daily Genotropin over 12 months.
- The main measure is annualized height velocity after 12 months of treatment.
- The trial aims to show that weekly somatrogon is non-inferior to daily Genotropin.
What is somatrogon?
Somatrogon is a man-made version of the human growth hormone, which is naturally produced by the pituitary gland and is necessary to stimulate growth in children. It belongs to the drug class of growth hormones. The medicine is marketed under the brand name Ngenla as a 60 mg/1.2 ml solution for injection in pre-filled pens. Somatrogon is authorised as a medicine in the UK and EU, where it is used to treat growth failure caused by growth hormone deficiency.
How does somatrogon work?
Somatrogon works by binding to the growth hormone receptor on the surface of target cells in the body. This binding triggers signals inside the cell that lead to the effects of growth hormone, including stimulation of growth. As a long-acting form of growth hormone, somatrogon is designed to be given less frequently than daily growth hormone preparations.
Which conditions is somatrogon used or studied for?
- Growth hormone deficiency — a condition in which the body does not produce enough growth hormone, leading to growth failure in children. Somatrogon is authorised for this use.
- Small for gestational age (SGA) — children born smaller than expected for their gestational age, who may have ongoing growth problems. This is being studied in the authorised Phase 3 trial.
- Idiopathic short stature (ISS) — short stature with no identified cause. This is also being studied in the authorised Phase 3 trial.
How is somatrogon given?
Somatrogon is given by subcutaneous injection, which means it is injected under the skin. It is available as a solution for injection in pre-filled pens, with the licensed product containing 60 mg of somatrogon in 1.2 ml. In the authorised trial, somatrogon is given once weekly, while the comparison medicine Genotropin is given daily.
What do the clinical trials show?
One Phase 3 trial of somatrogon is authorised in the EU Clinical Trials Information System. This interventional trial plans to enrol 245 children with either small for gestational age or idiopathic short stature. The trial compares weekly somatrogon (Ngenla) with daily Genotropin.
What is the trial measuring?
The main outcome measure is annualized height velocity after 12 months of treatment, which describes how fast a child grows over one year. The purpose of the trial is to demonstrate that the treatment effect of weekly somatrogon is non-inferior to daily Genotropin, meaning it is not meaningfully worse.
Who can take part?
The trial is open to children born small for gestational age or with idiopathic short stature. Somatrogon has been studied in children aged 3 years and older, but safety and efficacy have not been established in children younger than 3 years of age.
What side effects are known?
The available sources do not provide a detailed list of side effects for somatrogon. The medicine is available only with a doctor's prescription, and the risks of taking the medicine must be weighed against the benefits.