Somatrogon API Manufacturers

General Description:

Somatrogon, identified by CAS number 1663481-09-1, is a notable compound with significant therapeutic applications. 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. 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. 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. The glycosylation and the presence of CTPs in the protein sequence prolongs the half-life of somatrogon and allows its once-weekly dosing. 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. It is available as a once-weekly subcutaneous injection.

Indications:

This drug is primarily indicated for: 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). Its use in specific medical scenarios underscores its importance in the therapeutic landscape.

Metabolism:

Somatrogon undergoes metabolic processing primarily in: Somatrogon is expected to undergo protein catabolism, with subsequent reclamation of the amino acids and return to the systemic circulation. This metabolic pathway ensures efficient processing of the drug, helping to minimize potential toxicity and side effects.

Absorption:

The absorption characteristics of Somatrogon are crucial for its therapeutic efficacy: Following subcutaneous administration of 0.66 mg/kg/wk in pediatric patients with growth hormone deficiency, C_max of somatrogon was 690 ng/mL. T_max 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. The drug's ability to rapidly penetrate into cells ensures quick onset of action.

Half-life:

The half-life of Somatrogon is an important consideration for its dosing schedule: 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. This determines the duration of action and helps in formulating effective dosing regimens.

Protein Binding:

Somatrogon exhibits a strong affinity for binding with plasma proteins: There is no information available. This property plays a key role in the drug's pharmacokinetics and distribution within the body.

Route of Elimination:

The elimination of Somatrogon from the body primarily occurs through: There is no information available. Understanding this pathway is essential for assessing potential drug accumulation and toxicity risks.

Volume of Distribution:

Somatrogon is distributed throughout the body with a volume of distribution of: 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. This metric indicates how extensively the drug permeates into body tissues.

Clearance:

The clearance rate of Somatrogon is a critical factor in determining its safe and effective dosage: Following subcutaneous administration of 0.66 mg/kg/wk in pediatric patients with growth hormone deficiency, the clearance was 0.0336 L/h/kg. It reflects the efficiency with which the drug is removed from the systemic circulation.

Pharmacodynamics:

Somatrogon exerts its therapeutic effects through: 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). The drug's ability to modulate various physiological processes underscores its efficacy in treating specific conditions.

Mechanism of Action:

Somatrogon functions by: Growth hormone is a key hormone that promotes body growth and regulates carbohydrate, protein and lipid metabolism. 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. One of the activated signalling pathways is the STAT5b signalling pathway, which is critical for the effect of GH on body height. This mechanism highlights the drug's role in inhibiting or promoting specific biological pathways, contributing to its therapeutic effects.

Toxicity:

Classification:

Somatrogon belongs to the None, classified under the direct parent group Peptides. This compound is a part of the Organic Compounds, falling under the Organic Acids superclass, and categorized within the Carboxylic Acids and Derivatives class, specifically within the Amino Acids, Peptides, and Analogues subclass.

Categories:

Somatrogon is categorized under the following therapeutic classes: Amino Acids, Peptides, and Proteins, Anterior Pituitary Lobe Hormones and Analogues, Growth Hormone, Hormones, Hormones, Hormone Substitutes, and Hormone Antagonists, Peptide Hormones, Peptides, Pituitary and Hypothalamic Hormones and Analogues, Pituitary Hormones, Pituitary Hormones, Anterior, Recombinant Human Growth Hormone, Somatropin and Somatropin Agonists, Systemic Hormonal Preparations, Excl. Sex Hormones and Insulins. These classifications highlight the drug's diverse therapeutic applications and its importance in treating various conditions.

Experimental Properties:

Further physical and chemical characteristics of Somatrogon include:

• Molecular Weight: 30465.1
• Molecular Formula: C1359H2125N361O420S7