Somapacitan

Somapacitan-beco binds to a dimeric GH receptor in the cell membrane of target cells resulting in intracellular signal transduction and a host of pharmacodynamic effects. Some of these pharmacodynamic effects are primarily mediated by insulin-like growth factor-1 (IGF-1) produced in the liver, while others are primarily a consequence of the direct effects of somapacitan-beco.

• SOGROYA is indicated for the treatment of pediatric patients aged 2.5 years and older with: • Growth failure due to inadequate secretion of endogenous growth hormone (GH). • Short stature born small for gestational age (SGA) and with no catch-up growth by 2 years of age.

• SOGROYA is contraindicated in patients with: • Acute critical illness after open-heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure because of the risk of increased mortality with use of pharmacologic doses of SOGROYA [see Warnings and Precautions ( 5.1 )] . • Hypersensitivity to SOGROYA or any of its excipients.contraindicated

• SOGROYA treatment should be supervised by a healthcare provider who is experienced in the diagnosis and management of patients with growth hormone deficiency, pediatric patients born SGA, pediatric patients with NS, and pediatric patients with ISS. ( 2.1 ) • SOGROYA should be administered by subcutaneous injection once weekly, any time of the day, in the upper arms, thigh, abdomen or buttocks with regular rotation of injection site to avoid lipohypertrophy/lipoatrophy. ( 2.1 ) • See Full Prescribing Information for complete dosage, titration, and monitoring recommendations for pediatric and adult patients, including those aged 65 years and older, patients with hepatic impairment, and women receiving oral estrogen. ( 2.1 , 2.2 , 2.3 , 2.4 , 2.5 ) For pediatric patients : • GH deficiency: Initiate SOGROYA with a dosage of 0.16 mg/kg body weight once weekly for treatment-naïve patients and patients switching from daily growth hormone (somatropin). ( 2.3 ) • SGA/NS/ISS: Initiate SOGROYA with a dosage of 0.24 mg/kg body weight once weekly for treatment-naïve patients and patients switching from daily growth hormone (somatropin). ( 2.3 ) • Individualize dosage for each patient based on the growth response. ( 2.3 ) • Patients switching from daily human growth hormone to once-weekly SOGROYA should choose the preferred day for the weekly dose and stop final dose of daily treatment the day before (or at least 8 hours before) taking the first dose of once-weekly somapacitan-beco.

• Severe Hypersensitivity : Serious hypersensitivity reactions, including anaphylactic reactions and angioedema, may occur. In the event of an allergic reaction, seek prompt medical attention. ( 5.2 ) • Increased Risk of Neoplasm : Monitor patients with preexisting tumors for progression or recurrence. Increased risk of a second neoplasm in childhood cancer survivors treated with somatropin – in particular meningiomas in patients treated with radiation to the head for their first neoplasm. ( 5.3 ) • Glucose Intolerance and Diabetes Mellitus : SOGROYA may decrease insulin sensitivity, particularly at higher doses. Monitor glucose levels periodically in all patients receiving SOGROYA, especially in patients with existing diabetes mellitus or at risk for its development. ( 5.4 ) • Intracranial Hypertension (IH) : Perform fundoscopic examinations prior to initiation and periodically thereafter. If papilledema is identified prior to initiation, evaluate the etiology and treat the underlying cause before initiating. If papilledema occurs with SOGROYA, stop treatment. ( 5.5 ) • Fluid Retention : Was observed and may be dose dependent. Reduce dose as necessary. ( 5.6 ) • Hypoadrenalism : Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism. ( 5.7 ) • Hypothyroidism : Monitor thyroid function periodically as hypothyroidism may occur or worsen after initiation of SOGROYA. ( 5.8 ) • Slipped Capital Femoral Epiphysis in Pediatric Patients : May develop.

The following clinically significant adverse drug reactions are described elsewhere in the labeling: • Increased mortality in patients with acute critical illness [see Warnings and Precautions ( 5.1 )] • Severe hypersensitivity [see Warnings and Precautions ( 5.2 )] • Increased risk of neoplasms [see Warnings and Precautions ( 5.3 )] • Glucose intolerance and diabetes mellitus [see Warnings and Precautions ( 5.4 )] • Intracranial hypertension [see Warnings and Precautions ( 5.5 )] • Fluid retention [see Warnings and Precautions ( 5.6 )] • Hypoadrenalism [see Warnings and Precautions ( 5.7 )] • Hypothyroidism [see Warnings and Precautions ( 5.8 )] • Slipped capital femoral epiphysis in pediatric patients [see Warnings and Precautions ( 5.9 )] • Progression of preexisting scoliosis in pediatric patients [see Warnings and Precautions ( 5.10 )] • Pancreatitis [see Warnings and Precautions ( 5.11 )] • Lipohypertrophy/Lipoatrophy [see Warnings and Precautions ( 5.12 )] • Sudden death in pediatric patients with Prader-Willi syndrome [see Warnings and Precautions ( 5.13 )] • Common adverse reactions reported in pediatric patients treated with SOGROYA include: cough, diarrhea, ear infection, headache, injection site reaction, nasopharyngitis, pain in extremity, pyrexia, respiratory tract infection, and vomiting.

8.1 Pregnancy Risk Summary There are no available data on the use of SOGROYA during pregnancy; however, published studies describing the use of short-acting recombinant growth hormone (rhGH) during pregnancy over several decades have not identified any drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, subcutaneously administered somapacitan-beco was not teratogenic in rats or rabbits during organogenesis at doses approximately 12 times the clinical exposure at the maximum recommended human dose (MRHD) of 8 mg/week. No adverse developmental outcomes were observed in a pre- and post-natal development study with administration of somapacitan-beco to pregnant rats from organogenesis through lactation at approximately 275 times the clinical exposure at the MRHD (see Data) . The background risk of birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In an embryo-fetal development study in rats, somapacitan-beco was administered by subcutaneous injection at doses of 2, 6, and 18 mg/kg/day during the period of organogenesis from gestation day 6 to 17.

Metabolism

Somapacitan-beco has pharmacokinetic properties compatible with once weekly administration. The reversible binding to endogenous albumin delays elimination of somapacitan and thereby prolongs the in vivo half-life and duration of action.

Acute overdosage could lead initially to hypoglycemia and subsequently to hyperglycemia. Overdose with SOGROYA is likely to cause fluid retention. Long-term overdosage could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of excess endogenous growth hormone.

• Aug 28, 2020BLABLA761156Novo Nordisk Inc

1. 1Headache1411%
2. 2Rash53.9%
3. 3Abdominal Pain43.1%
4. 4Arthralgia43.1%
5. 5Condition Aggravated43.1%
6. 6Hospitalisation43.1%
7. 7Hypoglycaemia43.1%
8. 8Pain In Extremity43.1%
9. 9Pyrexia43.1%
10. 10Seizure43.1%
11. 11Vomiting43.1%
12. 12Completed Suicide32.4%
13. 13Drug Ineffective32.4%
14. 14Injection Site Pain32.4%
15. 15Oral Pain32.4%

The 10 most recently updated of 21 ClinicalTrials.gov registrations naming Somapacitan as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow
  Active not recruiting · Phase 3 · Interventional · 412 enrolled · Novo Nordisk A/S
  NCT05330325updated 2026-06-12
• A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information
  Enrolling by invitation · Observational · 400 enrolled · Novo Nordisk A/S
  NCT05718570updated 2026-06-12
• A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day
  Active not recruiting · Phase 2 · Interventional · 62 enrolled · Novo Nordisk A/S
  NCT03878446updated 2026-06-10
• A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4)
  Completed · Phase 3 · Interventional · 200 enrolled · Novo Nordisk A/S
  NCT03811535updated 2026-05-22
• Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due to Growth Hormone Deficiency Where Epiphysial Discs Are Not Closed
  Enrolling by invitation · Observational · 200 enrolled · Novo Nordisk A/S
  NCT06109935updated 2026-04-29
• Growth Hormone for the Treatment of Gastroparesis
  Recruiting · Early phase 1 · Interventional · 10 enrolled · Mayo Clinic
  NCT06803589updated 2026-04-16
• Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya®
  Active not recruiting · Observational · 200 enrolled · Novo Nordisk A/S
  NCT05230550updated 2026-04-13
• A Study to Follow Paediatric Participants With Growth Hormone Deficiency Treated With Somapacitan for Long Term Safety Information and Clinical Parameters
  Enrolling by invitation · Observational · 500 enrolled · Novo Nordisk A/S
  NCT06709040updated 2026-04-06
• Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency
  Completed · Phase 2 · Interventional · 76 enrolled · Novo Nordisk A/S
  NCT02616562updated 2026-01-16
• A Research Study in Chinese Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day.
  Completed · Phase 3 · Interventional · 110 enrolled · Novo Nordisk A/S
  NCT04970654updated 2026-01-06

Frequently asked questions

How does Somapacitan work?

Somapacitan-beco binds to a dimeric GH receptor in the cell membrane of target cells resulting in intracellular signal transduction and a host of pharmacodynamic effects. Some of these pharmacodynamic effects are primarily mediated by insulin-like growth factor-1 (IGF-1) produced in the liver, while others are primarily a consequence of the direct effects of somapacitan-beco.

What is Somapacitan used for?

According to FDA labeling, Somapacitan carries indications including: SOGROYA is indicated for the treatment of pediatric patients aged 2.5 years and older with: • Growth failure due to inadequate secretion of endogenous growth hormone (GH). • Short stature born small for gestational age (SGA) and with no catch-up growth by 2 years of age.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Somapacitan?

Somapacitan is classified as Somatropin and somatropin agonists.

What are the brand names for Somapacitan?

Somapacitan is marketed under brand names including Sogroya.

What are the contraindications for Somapacitan?

Somapacitan labeling lists contraindications including: SOGROYA is contraindicated in patients with: • Acute critical illness after open-heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure because of the risk of increased mortality with use of pharmacologic doses of SOGROYA [see Warnings and Precautions ( 5.1 )] . • Hypersensitivity to SOGROYA or any of its excipients.. Always consult the full prescribing information and a clinician.