Overview
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. In June 2023, the FDA approved the use of somatrogon also for the treatment of pediatric growth hormone deficiency. Somatrogon is available as a once-weekly subcutaneous injection.
Indication
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).
Associated Conditions
- Growth Failure
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/09/19 | N/A | Recruiting | |||
2022/11/02 | N/A | Active, not recruiting | |||
2022/08/22 | N/A | Active, not recruiting | |||
2019/03/14 | Phase 3 | Completed | |||
2019/02/06 | Phase 3 | Completed | |||
2019/01/22 | Phase 1 | Completed | |||
2016/11/18 | Phase 3 | Completed | |||
2015/07/16 | Phase 2 | Completed | |||
2015/04/16 | Phase 1 | Completed | |||
2013/07/26 | Phase 3 | Terminated |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 2/14/2022 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
NGENLA SOLUTION FOR INJECTION IN A PRE-FILLED PEN 60 MG/1.2ml | SIN16912P | INJECTION, SOLUTION | 60mg/1.2ml | 12/14/2023 | |
NGENLA SOLUTION FOR INJECTION IN A PRE-FILLED PEN 24 MG/1.2ml | SIN16911P | INJECTION, SOLUTION | 24mg/1.2ml | 12/14/2023 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
NGENLA somatrogon 24 mg solution for injection cartridge in prefilled pen | 349990 | Medicine | A | 11/30/2021 | |
NGENLA somatrogon 60 mg solution for injection cartridge in prefilled pen | 350035 | Medicine | A | 11/30/2021 |
Help Us Improve
Your feedback helps us provide better drug information and insights.