Synopsis
Synopsis
0
API Suppliers
0
USDMF
0
CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
NDC API
0
VMF
0
Listed Suppliers
0
API
0
FDF
0
Europe
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
0
EDQM
0
USP
0
JP
0
Others
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
US Medicaid
NA
Annual Reports
NA
Finished Drug Prices
NA
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.
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
ABOUT THIS PAGE
A Somapacitan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Somapacitan, including repackagers and relabelers. The FDA regulates Somapacitan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Somapacitan API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Somapacitan supplier is an individual or a company that provides Somapacitan active pharmaceutical ingredient (API) or Somapacitan finished formulations upon request. The Somapacitan suppliers may include Somapacitan API manufacturers, exporters, distributors and traders.
Somapacitan Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Somapacitan GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Somapacitan GMP manufacturer or Somapacitan GMP API supplier for your needs.
A Somapacitan CoA (Certificate of Analysis) is a formal document that attests to Somapacitan's compliance with Somapacitan specifications and serves as a tool for batch-level quality control.
Somapacitan CoA mostly includes findings from lab analyses of a specific batch. For each Somapacitan CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Somapacitan may be tested according to a variety of international standards, such as European Pharmacopoeia (Somapacitan EP), Somapacitan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Somapacitan USP).
LOOKING FOR A SUPPLIER?
