1. Nn-8640
2. Sogroya
3. Somapacitan-beco
1. 1338578-34-9
2. Somapacitan [inn]
3. Somapacitan [who-dd]
4. Somapacitan [usan:inn]
5. Unii-8foj430u94
6. 8foj430u94
7. Ex-a4353
8. Q27270325
| Molecular Weight | 1310.5 g/mol |
|---|---|
| Molecular Formula | C54H95N13O20S2 |
| XLogP3 | -2.1 |
| Hydrogen Bond Donor Count | 13 |
| Hydrogen Bond Acceptor Count | 25 |
| Rotatable Bond Count | 59 |
| Exact Mass | 1309.62577482 g/mol |
| Monoisotopic Mass | 1309.62577482 g/mol |
| Topological Polar Surface Area | 544 Ų |
| Heavy Atom Count | 89 |
| Formal Charge | 0 |
| Complexity | 2220 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 4 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
Somapacitan is indicated as a replacement for growth hormone in adult patients with growth hormone deficiency.
Treatment of short stature
Treatment of growth hormone deficiency
Sogroya is indicated for the replacement of endogenous growth hormone (GH) in adults with growth hormone deficiency (AGHD).
Somapacitan stimulates the growth hormone receptor. Somapacitan has a long duration of action as it is given once weekly. It has a moderately wide therapeutic window as an acute overdose may cause hypoglycemia followed by hyperglycemia. Patients should be counselled regarding the risk of increased mortality in patients with critical illness, risk of neoplasms, glucose intolerance in diabetes mellitus, intracranial hypertension, hypersensitivity, fluid retention, hypoadrenalism, hypothyroidism, pancreatitis, lipohypertrophy, and lipoatrophy.
H - Systemic hormonal preparations, excl. sex hormones and insulins
H01 - Pituitary and hypothalamic hormones and analogues
H01A - Anterior pituitary lobe hormones and analogues
H01AC - Somatropin and somatropin agonists
H01AC07 - Somapacitan
Absorption
A 0.02mg/kg single dose of somapacitan reaches a Cmax of 14.4 ng/mL, with a Tmax of 11.1 hours, and an AUC of 475 ng\*h/mL. A 0.04mg/kg single dose of somapacitan reaches a Cmax of 19.8 ng/mL, with a Tmax of 25.6 hours, and an AUC of 777 ng\*h/mL. A 0.08mg/kg single dose of somapacitan reaches a Cmax of 64.2 ng/mL, with a Tmax of 16.6 hours, and an AUC of 2753 ng\*h/mL. A 0.12mg/kg single dose of somapacitan reaches a Cmax of 142.5 ng/mL, with a Tmax of 22.5 hours, and an AUC of 6382 ng\*h/mL.
Route of Elimination
Somapacitan is approximately 81% eliminated in the urine and 13% in the feces.
Volume of Distribution
The approximate volume of distribution of somapacitan is 14.6 L.
Clearance
The apparent maximum rate of saturable elimination is estimated to be 0.268 0.03 mg/h.
Studies in humans and rats show that somapacitan is metabolized through cleavage of the albumin-binding moiety and linker sidechain before further non-specific mechanisms.
The elimination half life of somapacitan is 2-3 days.
Somapacitan binds to the growth hormone receptor and induces intracellular signalling to up-regulate insulin-like growth factor I (IGF-1). IGF-1 causes growth in bones and muscle tissue. Growth hormones more directly cause the fusion of myoblasts and myotubes to cause muscle fibre growth, activate neural stem cells, and induce chondrocyte proliferation.
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