In studies of adults who had not been treated before, this medicine brought average IGF-1 levels into the normal range. Sogroya is approved for adults with growth hormone deficiency (GHD). It is also approved for children ages 2.5 years and older who have GHD, were born small for gestational age (SGA) and did not catch up in height by age 2, have growth failure linked to Noonan syndrome (NS), or have idiopathic short stature (ISS).
In February 2026, the FDA updated the label to add the once-weekly option for these additional child groups. Daily growth hormone shots have been used for many years. A weekly schedule may help you and your caregiver stick with treatment. Sogroya is the first and only once-weekly, long-acting growth hormone cleared for ISS, SGA, and NS in children.
This medicine comes as a prefilled pen for use under the skin once a week. Your health care provider can show you how to inject in the belly area or thighs and how to rotate the site each week to protect your skin. The FDA has cleared step-by-step “Instructions for Use” to support correct, steady use.
Why Was It Approved?
The FDA’s expanded child approvals relied on a yearlong randomized study in treatment‑naive, pre‑pubertal children with short stature from ISS, SGA, or NS. In that study, once‑weekly Sogroya grew height at about the same rate as daily growth hormone over 52 weeks. Some daily somatropin doses used in the comparison were lower than the maximum U.S. dose, which is important context when you read the results.
For children with GHD, another 52‑week study found similar height gain with weekly Sogroya and daily somatropin. In adults with GHD, Sogroya lowered belly and trunk fat, compared with a placebo, and brought average IGF‑1 into the normal range after 34 weeks.
Like other growth hormone treatments, a cancer history needs careful review. In people who had cancer in childhood and received radiation to the head or brain, an increased risk of a second cancer has been reported with growth hormone use. Your health care provider may suggest long‑term follow‑up if this applies to you.
What Do I Need to Know?
Inject Sogroya once each week under the skin of the upper arm, thigh, belly, or buttocks. Rotate where you inject every week to avoid skin thickening or thinning. If you miss a dose, you can take it within three days of the planned day. If more than three days have passed, skip it and take the next dose on your usual day. Your health care provider may check your eyes before you start and over time with a fundoscopic exam.
Always attach a new needle for every shot, and do not try to put the cap back on the used needle. Remove the needle from the pen right after the injection, and place used needles and pens into an FDA‑cleared sharps container. Do not throw loose needles into the trash or recycling. Never share your pen or needles, as sharing can spread infections.
Keep new pens in the refrigerator and do not freeze them. If needed, you may keep a pen at room temperature for up to three days and then return it to the refrigerator. Follow the temperature limits on the label.
Your health care provider will check your blood sugar because growth hormone can raise it. If you take steroid replacement, you may need higher daily or stress doses after starting Sogroya. If you take oral estrogen, you may need a higher Sogroya dose because estrogen can lower the IGF‑1 response.
