Sogroya

Sogroya (somapacitan-beco) is a once-weekly growth hormone injection used to treat growth failure in children aged 2.5 years and older, and growth hormone deficiency in adults.

Sogroya works by mimicking natural growth hormone by binding to receptors on target cells, stimulating growth via IGF-1 and direct cell effects. Unlike traditional growth hormone therapies that require daily injections, Sogroya is given once weekly as a subcutaneous (under-the-skin) injection using a prefilled pen.

Sogroya (somapacitan-beco) first received FDA approval in August 2020 for adults with growth hormone deficiency. The approval was extended to children with growth hormone deficiency in 2023, and in February 2026, the FDA approved three further pediatric indications: short stature in children born small for gestational age, growth failure associated with Noonan syndrome, and idiopathic short stature. Sogroya is now approved for four pediatric growth disorders and for adult growth hormone deficiency.

Approval was supported by three phase 3 trials:

• REAL 1 (NCT02229851) in treatment-naive adults with growth hormone deficiency
• REAL 4 (NCT03811535) in treatment-naive children with growth hormone deficiency
• A randomized, open-label, active-comparator basket study (NCT05330325) in treatment-naive children with short stature born small for gestational age, Noonan syndrome, or idiopathic short stature

Sogroya is manufactured by Novo Nordisk.

Sogroya is FDA-approved to treat the following conditions:

• In children 2.5 years of age and older: Growth hormone deficiency (GHD). Children who are not growing normally because their bodies produce too little or no growth hormone Small for gestational age (SGA) with no catch-up growth. Children who were born smaller than expected and have not caught up in height by age 2 Noonan syndrome. A genetic condition that can cause short stature and slow growth Idiopathic short stature (ISS). Children who are significantly shorter than average, with no identifiable medical cause
• In adults: Growth hormone deficiency (GHD). Adults whose pituitary gland does not produce enough growth hormone.

Read the detailed Instructions for Use that come with Sogroya.

Sogroya is injected subcutaneously (under the skin) once a week, at any time of day, into the upper arm, thigh, abdomen, or buttocks. Rotate the injection site each week to avoid skin changes at the injection site. Your healthcare provider will show you how to use the prefilled pen before you start treatment.

Sogroya is available in three prefilled pen strengths:

• 5 mg/1.5 mL pen (teal)
• 10 mg/1.5 mL pen (yellow)
• 15 mg/1.5 mL pen (red).

Do not use Sogroya if you or your child:

• Are critically ill following heart or abdominal surgery, trauma, or serious breathing problems
• Have active cancer or a tumor
• Have active proliferative diabetic retinopathy or severe non-proliferative diabetic retinopathy (certain types of eye damage caused by diabetes)
• Are a child with closed bone growth plates (epiphyses)
• Are a child with Prader-Willi syndrome who is severely obese or has breathing problems
• Are allergic to somapacitan-beco or any ingredient in Sogroya.

Before starting Sogroya, tell your healthcare provider if you or your child:

• Have had cancer or any tumor
• Have diabetes or pre-diabetes
• Have adrenal gland problems or take glucocorticoids
• Have thyroid gland problems
• Have liver problems
• Have a history of scoliosis (children)
• Have had heart or abdominal surgery, or serious respiratory illness
• Are pregnant or planning to become pregnant
• Are breastfeeding or planning to breastfeed.

Before starting Sogroya

• A fundoscopic eye examination to rule out existing papilledema (swelling of the optic nerve). If papilledema is found, the cause must be investigated and treated before Sogroya is started.
• Any existing cancer must be inactive and its treatment complete.

During Sogroya treatment

• IGF-1 blood levels. Doses are titrated against IGF-1. In adults, the blood sample should be drawn 3 to 4 days after the previous dose. Doses are reduced if IGF-1 rises above the normal range for the person's age and sex.
• Fundoscopic eye examinations. Repeated periodically during treatment.
• Blood glucose. Monitored periodically in everyone taking Sogroya, and more closely in people with diabetes, prediabetes, obesity, Turner syndrome or a family history of diabetes.
• Thyroid function tests. Checked periodically, since untreated hypothyroidism can blunt the response to Sogroya.
• Serum cortisol. Monitored in people with known hypoadrenalism, who may need their glucocorticoid replacement dose increased.
• Growth response in children. Height is measured regularly. If height velocity fails to increase, particularly in the first year, the prescriber will check adherence and look for other causes of poor growth such as hypothyroidism, undernutrition, advanced bone age, or antibodies to recombinant human growth hormone.
• Children treated in childhood who have finished growing. Anyone treated with Sogroya for growth hormone deficiency in childhood whose growth plates have closed should be reassessed before continuing Sogroya as an adult.

Laboratory changes

Growth hormone treatment, including Sogroya, can raise blood levels of inorganic phosphorus and alkaline phosphatase, and parathyroid hormone levels may also increase. In the adult trial, more people taking Sogroya than placebo shifted from normal to elevated phosphate levels (17.5% versus 4.9%) and creatine phosphokinase levels (9.2% versus 6.6%). These changes came and went during treatment and did not get progressively worse.

Pregnancy and Sogroya

It is not known whether Sogroya will harm an unborn baby. Talk to your healthcare provider if you are pregnant or planning to become pregnant before starting this medication.

Breastfeeding and Sogroya

It is not known whether Sogroya passes into breast milk. You and your healthcare provider should weigh the benefits and risks of using Sogroya while breastfeeding.

Common Sogroya side effects

These figures come from the clinical trials that supported FDA approval: 52 weeks of treatment in children and 34 weeks in adults.

Children

Reported in 5% or more of children treated for growth hormone deficiency.

In the trials in children born small for gestational age, with Noonan syndrome, or with idiopathic short stature, respiratory tract infections were the most common side effect, reported in 26% to 43% of children given Sogroya, followed by common cold symptoms in 22% to 29%.

Adults

Reported in more than 2% of adults, and more often than with placebo.

Osteonecrosis (bone tissue death from reduced blood supply) has been reported in children since approval. Because these reports are voluntary, how often it happens cannot be reliably estimated.

Increased risk of death in critical illness

Sogroya should not be used in people who are critically ill following open-heart surgery, abdominal surgery, multiple trauma, or acute respiratory failure. Use of growth hormone in these situations has been associated with increased mortality.

Cancer and tumors

Sogroya may stimulate the growth of existing tumors or cancers. Any active malignancy must be fully treated and in remission before starting Sogroya. People who received radiation to the brain or head as children and later developed growth hormone deficiency have a higher risk of developing a second tumor, particularly meningiomas. Your healthcare provider will monitor for any signs of tumor recurrence during treatment. Report any sudden changes in behavior, headaches, vision problems, or changes in moles or birthmarks to your doctor promptly.

High blood sugar and diabetes

Sogroya can reduce insulin sensitivity, which may raise blood sugar levels or worsen existing diabetes. Blood glucose will be monitored during treatment. People with pre-diabetes or diabetes will need closer monitoring, and doses of diabetes medicines may need adjustment.

Increased pressure in the skull (intracranial hypertension)

A build-up of pressure inside the skull has been reported with growth hormone therapy, usually within the first 8 weeks of treatment. Symptoms include headaches, vision changes, nausea, and vomiting. A fundoscopic eye examination is required before starting treatment. If intracranial hypertension develops, Sogroya will need to be stopped.

Fluid retention

Sogroya can cause the body to retain fluid, leading to swelling in the hands and feet, joint or muscle pain, and nerve compression symptoms such as tingling or burning in the hands, arms, or legs (carpal tunnel syndrome). These effects are usually temporary and dose-dependent. Tell your healthcare provider if you notice these symptoms.

Low cortisol (hypoadrenalism)

Sogroya can lower cortisol levels, particularly in people who already have or are at risk for adrenal insufficiency. People taking glucocorticoid replacement therapy may need their dose increased after starting Sogroya. Symptoms of low cortisol include darkening of the skin, severe fatigue, dizziness, weakness, and weight loss.

Low thyroid hormone (hypothyroidism)

Sogroya can cause or worsen hypothyroidism, which may reduce how well the treatment works. Thyroid function tests will be checked periodically during treatment, and thyroid hormone replacement will be started or adjusted if needed.

Pancreatitis

Cases of pancreatitis (inflammation of the pancreas) have been reported with growth hormone therapy. The risk may be higher in children. Tell your healthcare provider about any new or persistent severe abdominal pain.

Injection site changes (lipohypertrophy/lipoatrophy)

Repeatedly injecting Sogroya into the same area can cause the skin to thicken or develop dents. Rotating injection sites with each weekly dose reduces this risk.

Slipped capital femoral epiphysis (children)

Children treated with growth hormone may develop a condition where the thigh bone slips at the hip joint. This can lead to osteonecrosis (bone tissue death due to reduced blood supply) if not treated promptly. Contact your healthcare provider immediately if your child develops a limp or hip or knee pain.

Worsening scoliosis (children)

Sogroya increases the rate of growth, which can cause pre-existing curvature of the spine (scoliosis) to worsen. Children with a history of scoliosis will be monitored during treatment.

Sudden death in children with Prader-Willi syndrome

There have been reports of sudden death in children with Prader-Willi syndrome who were severely obese or had breathing problems, including sleep apnea. Sogroya must not be used in children with Prader-Willi syndrome.

Serious allergic reactions

Sogroya can cause severe allergic reactions, including anaphylaxis and angioedema. Get emergency medical help immediately if you or your child develops swelling of the face, lips, mouth, or tongue; skin rashes, redness, or swelling; trouble breathing; wheezing; dizziness or fainting; fast heartbeat; or severe itching and sweating.

Notes

This is not a complete list of side effects. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or to Novo Nordisk at 1-888-668-6444.

Sogroya is a human growth hormone analog, which is a laboratory-made version of the growth hormone the body produces naturally. It works by binding to growth hormone receptors on target cells throughout the body, triggering signals that stimulate growth and metabolism.

Some of Sogroya's effects are indirect, working through a protein called insulin-like growth factor-1 (IGF-1) that is released from the liver in response to the drug. Other effects result from the medication acting directly on cells. Together, these actions mimic the body's natural growth hormone activity.

What makes Sogroya different from standard daily growth hormone products (somatropin) is its albumin-binding design. Sogroya attaches to albumin, a protein naturally present in the blood, which slows its breakdown and extends its activity throughout the week, allowing once-weekly dosing.

Sogroya was compared with daily somatropin injections in four groups of children and in adults. Growth in children is measured as annualized height velocity, which is how many centimeters a child grows over a year.

Growth in children after one year

Growth with once-weekly Sogroya was similar to daily injections in every group. Children born small for gestational age grew faster on Sogroya than on the lower of the two daily doses studied, and about the same as on the higher dose. The trials ran for 52 weeks in children aged 2 to 11 years who had not been treated with growth hormone before. In the Noonan syndrome, idiopathic short stature and small for gestational age trials, the daily somatropin comparator dose was lower than the maximum dose approved for those conditions in the United States.

Results in adults

In a 34-week trial in adults with growth hormone deficiency, Sogroya reduced truncal fat by 1.53% more than placebo (p=0.0090) and brought the average IGF-1 level back into the normal range. Truncal fat fell by 2.23% in adults given daily somatropin, but Sogroya and daily somatropin were not formally compared.

Sogroya dosing in specific situations

• Adults aged 65 years and older. Start at 1 mg once weekly and use smaller increments when increasing the dose.
• Women taking oral estrogen. Start at 2 mg once weekly. Oral estrogens reduce the IGF-1 response to Sogroya, so higher doses are usually needed.
• Moderate liver impairment in adults. Start at 1 mg once weekly, use smaller dose increments, and do not exceed 4 mg once weekly.
• Mild liver impairment. No dose adjustment is needed in adults or children.
• Moderate or severe liver impairment in children. Sogroya is not recommended.
• Severe liver impairment in adults. Sogroya is not recommended, as it has not been studied in this group.
• Switching from another weekly growth hormone. Continue the same once-weekly dosing schedule.
• Switching from daily growth hormone. Choose the preferred day for the weekly dose and take the final daily dose the day before, or at least 8 hours before, the first Sogroya dose.

Which Sogroya pen delivers which dose?

Each pen strength covers a different dose range and turns in different increments, so the pen a person is prescribed depends on their weekly dose.

All three pen strengths can be used with the FlexPro PenMate, an accessory device that covers the needle during injection. The PenMate is dispensed separately and comes with its own Instructions for Use.

If you miss a dose of Sogroya, take it as soon as possible if it is within 3 days (72 hours) of your scheduled dose. Then resume your regular weekly dosing schedule. If more than 3 days have passed since the missed dose, skip it entirely and take your next dose on your usual scheduled day. Do not take two doses to make up for a missed one.

An overdose of growth hormone may initially cause low blood sugar (hypoglycemia), followed by high blood sugar (hyperglycemia). Long-term overdosage could cause signs of gigantism (in children) or acromegaly (in adults). As Sogroya is administered in a clinical or home setting under medical supervision, contact your healthcare provider or poison control if an overdose is suspected.

Tell your healthcare provider about all medicines, vitamins, and supplements you take. Sogroya has the following clinically important drug interactions:

• Glucocorticoids. People taking glucocorticoid replacement for adrenal insufficiency may need their dose increased after starting Sogroya, as growth hormone can affect cortisol metabolism
• Cytochrome P450-metabolized drugs. Sogroya may alter the clearance of drugs broken down by liver enzymes (CYP450). Careful monitoring is advised when these drugs are used together
• Oral estrogen. Women taking oral estrogen replacement may require higher doses of Sogroya, as oral estrogen reduces IGF-1 response to growth hormone
• Insulin and antihyperglycemic agents. Because Sogroya can reduce insulin sensitivity, diabetes medication doses may need adjustment.

This is not a complete list of interactions. See the Sogroya Prescribing Information for more information.

Store Sogroya in a refrigerator at 36°F to 46°F (2°C to 8°C), with the cap on, in the original carton to protect it from light. Do not freeze Sogroya, and do not use a pen that has been frozen. Keep pens away from direct or excessive heat and out of sunlight.

The 72-hour allowance is the total time a pen can spend at room temperature, whether it has been opened or not. Pens stored at room temperature can be returned to the refrigerator within that time. Discard any pen that has been kept above 86°F (30°C).

Other storage points:

• Write the date of first use in the space provided on the carton
• Remove and safely discard the needle after every injection, and store the pen without a needle attached
• Use a new needle for each injection to prevent contamination
• Sogroya pens are for one person only. Do not share a pen or needle with anyone else, even if the needle has been changed
• Do not use Sogroya after the expiration date on the carton or pen

Keep Sogroya and all medicines out of the reach of children.

Active ingredient: somapacitan-beco

Inactive ingredients: histidine, mannitol, phenol, poloxamer 188, Water for Injection, and hydrochloric acid and sodium hydroxide (as needed to adjust pH).

Sogroya is manufactured by Novo Nordisk Inc., Plainsboro, NJ 08536. For more information, visit www.sogroya.com or call 1-888-668-6444.