Last reviewed · How we verify
Sogroya (SOMAPACITAN)
Sogroya works by binding to the growth hormone receptor, mimicking the action of growth hormone and stimulating growth and development.
SOMAPACITAN (Sogroya), marketed by Novo Nordisk, is a growth hormone analog indicated for growth failure due to inadequate GH secretion, competing in a well-established market with drugs like somatropin, somatrem, mecasermine, sermorelin, and mecasermin rinfabate. Its key competitive advantage lies in its mechanism of action, which mimics the natural action of growth hormone by binding to the growth hormone receptor, potentially offering improved efficacy and convenience. The primary risk to Sogroya's market position is the expiration of its key composition patent in 2028, which could lead to increased competition from generics and biosimilars.
At a glance
| Generic name | SOMAPACITAN |
|---|---|
| Sponsor | Novo Nordisk |
| Target | Growth hormone receptor |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2020 |
Mechanism of action
Somapacitan-beco binds to dimeric GH receptor in the cell membrane of target cells resulting in intracellular signal transduction and host of pharmacodynamic effects. Some of these pharmacodynamic effects are primarily mediated by insulin-like growth factor (IGF-1) produced in the liver, while others are primarily consequence of the direct effects of somapacitan-beco.
Approved indications
- Growth failure due to inadequate GH secretion
- Short stature, SGA without catch-up growth
- Growth failure associated with Noonan syndrome
- Idiopathic Short Stature
- Growth hormone deficiency in adults
Common side effects
- Back pain
- Dyspepsia
- Sleep disorder
- Dizziness
- Tonsillitis
- Peripheral edema
- Vomiting
- Adrenal insufficiency
- Hypertension
- Blood creatine phosphokinase increase
- Weight increased
- Anemia
Drug interactions
- Cortisone acetate, Prednisone
- Cytochrome P450-metabolized drugs
- Oral Estrogen
- Insulin and/or Other Hypoglycemic Agents
Key clinical trials
- A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow (PHASE3)
- A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information
- Growth Hormone for the Treatment of Gastroparesis (EARLY_PHASE1)
- 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 (PHASE2)
- 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. (PHASE3)
- 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) (PHASE3)
- A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (PHASE2)
- A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9 (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Sogroya CI brief — competitive landscape report
- Sogroya updates RSS · CI watch RSS
- Novo Nordisk portfolio CI