|
| Primary information |
|---|
| ID | 15686 |
| Therapeutic ID | Th1618 |
| Protein Name | Somatrogon |
| Sequence | >Th1618_Somatrogon
SSSSKAPPPSLPSPSRLPGPSDTPILPQFPTIPLSRLFDNAMLRAHRLHQLAFDTYQEFEEAYIPKEQKYSFLQNPQTSLCFSESIPTPSNREETQQKSNLELLRISLLLIQSWLEPVQFLRSVFANSLVYGASDSNVYDLLKDLEEGIQTLMGRLEDGSPRTGQIFKQTYSKFDTNSHNDDALLKNYGLLYCFRKDMDKVETFLRIVQCRSVEGSCGFSSSSKAPPPSLPSPSRLPGPSDTPILPQSSSSKAPPPSLPSPSRLPGPSDTPILPQ
|
| Molecular Weight | 30465.1 |
| Chemical Formula | C1359H2125N361O420S7 |
| Isoelectric Point | NA |
| Hydrophobicity | NA |
| Melting point | NA |
| Half-life | Following subcutaneous administration of 0.66 mg/kg/wk in pediatric patients with growth hormone deficiency, the half-life was 28.3 hours. Somatrogon was detected in the circulation for about 6 days after the last dose.[L39362] |
| Description | Somatrogon is a long-acting recombinant human growth hormone. Growth hormone is a peptide hormone secreted by the pituitary gland that plays a crucial role in promoting longitudinal growth during childhood and adolescence and regulating metabolic function in adulthood.[A241515] Recombinant growth hormone therapy for growth hormone deficiency and other conditions has been available since 1985, with daily administration being the standard treatment for many years. More recently, longer-acting forms of growth hormone were developed to improve patient adherence and thus, improve the therapeutic efficacy of treatment.[A241485] Somatrogon was produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology. It is a chimeric product generated by fusing three copies of the C-terminal peptide (CTP), or 28 carboxy-terminal residues, from the beta chain of human chorionic gonadotropin (hCG) to the N-terminus and C-terminus of human growth hormone.[A241515,L39362] The glycosylation and the presence of CTPs in the protein sequence prolongs the half-life of somatrogon and allows its once-weekly dosing.[L39362] In October 2021, Health Canada approved somatrogon under the market name NGENLA as the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone caused by growth hormone deficiency, marking Canada as the first country to approve this drug.[L39060] It is available as a once-weekly subcutaneous injection.[L39080] |
| Indication/Disease | Somatrogon is indicated for the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone (growth hormone deficiency).[L39362] |
| Pharmacodynamics | Somatrogon mimics the physiological actions of endogenous growth hormone, such as cell proliferation, metabolism, and growth. It was also shown to increase the serum concentration of insulin-like growth factor (IGF-1).[L39362] |
| Mechanism of Action | Growth hormone is a key hormone that promotes body growth and regulates carbohydrate, protein and lipid metabolism.[A243092] Somatrogon is a hormone replacement therapy that aims to restore deficient levels of growth hormone (GH). Like endogenous growth hormone, somatrogon binds to the GH receptor, which leads to the binding of JAK2 to GH receptor and activation of JAK2. Activation of JAK2 and phosphorylation of both JAK2 and GHR initiates the recruits various signalling proteins and facilitates multiple signalling pathways responsible for growth and metabolism.[A243092] One of the activated signalling pathways is the STAT5b signalling pathway, which is critical for the effect of GH on body height.[L39362] |
| Toxicity | Subcutaneous doses of somatrogon higher than 0.66 mg/kg per week have not been studied. Based on existing clinical data of other growth hormone products, short-term overdosage from somatrogon could lead initially to hypoglycemia and subsequently to hyperglycemia. Long-term overdosage could result in signs and symptoms of gigantism or acromegaly consistent with the effects of excess growth hormone. Overdose with somatrogon should be treated with general supportive measures.[L39362] |
| Metabolism | Somatrogon is expected to undergo protein catabolism, with subsequent reclamation of the amino acids and return to the systemic circulation.[L39362] |
| Absorption | Following subcutaneous administration of 0.66 mg/kg/wk in pediatric patients with growth hormone deficiency, Cmax of somatrogon was 690 ng/mL. Tmax was 8 hours and the AUC was 21800 ng x h/mL. Over the dose range of 0.25-0.66 mg/kg/week, somatrogon exposure increased in a dose-proportional manner.[L39362] |
| Following subcutaneous administration of 0.66 mg/kg/wk in pediatric patients with growth hormone deficiency, the apparent central volume of distribution (Vc) was 0.812 L/kg and the apparent peripheral volume of distribution (Vt) was 0.169 L/kg. Somatrogon does not accumulate after once-weekly administration.[L39362] |
| Clearance | Following subcutaneous administration of 0.66 mg/kg/wk in pediatric patients with growth hormone deficiency, the clearance was 0.0336 L/h/kg.[L39362] |
| Categories | Recombinant Human Growth Hormone |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | NA |
| Target | NA |
| Brand Name | NA |
| Company | NA |
| Brand Description | NA |
| Prescribed For | NA |
| Chemical Name | NA |
| Formulation | NA |
| Physical Appearance | NA |
| Route of Administration | NA |
| Recommended Dosage | NA |
| Contraindication | NA |
| Side Effects | NA |
| Useful Link 1 | Link |
| Useful Link 2 | NA |
| Remarks | NA |