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PEG-somatropin
PEG-somatropin is a pegylated recombinant human growth hormone that binds to growth hormone receptors to promote growth, metabolism, and body composition changes.
PEG-somatropin is a pegylated (polyethylene glycol-conjugated) recombinant human growth hormone that binds to growth hormone receptors to promote growth, metabolism, and body composition changes. Used for Growth hormone deficiency in children, Growth hormone deficiency in adults.
At a glance
| Generic name | PEG-somatropin |
|---|---|
| Also known as | Jintrolong®, Polyethylene Glycol Recombinant Human Somatropin Injection, recombinant human growth hormone, peglyated growth hormone, PEG-GH |
| Sponsor | Changchun GeneScience Pharmaceutical Co., Ltd. |
| Drug class | Growth hormone receptor agonist |
| Target | Growth hormone receptor (GHR) |
| Modality | Small molecule |
| Therapeutic area | Endocrinology |
| Phase | FDA-approved |
Mechanism of action
Somatropin is a recombinant human growth hormone (hGH) that mimics endogenous GH by binding to growth hormone receptors on target tissues. Pegylation (attachment of polyethylene glycol) extends the drug's half-life, allowing for less frequent dosing compared to non-pegylated somatropin. This enables sustained activation of GH signaling pathways that regulate protein synthesis, lipolysis, and linear growth.
Approved indications
- Growth hormone deficiency in children
- Growth hormone deficiency in adults
Common side effects
- Injection site reactions
- Headache
- Arthralgia
- Carpal tunnel syndrome
- Fluid retention
- Hyperglycemia
Key clinical trials
- A Phase II Study of PEG-rhGH Injection for Short Children Born Small for Gestational Age: Efficacy, Safety, and Pharmacokinetics (PHASE2)
- The Efficacy and Safety of PEGylated GH for the Treatment of Short Stature in Chinese Children-GLOBE Reg
- A Study Extension Period of PEG-somatropin (Pegylated-somatropin) in the Treatment of Children With Idiopathic Short Stature (PHASE2)
- A Bioequivalence Study of Two Different PEG-rhGH Preparations (PHASE1)
- Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat SGA Children With Short Stature (PHASE2)
- A Clinical Trail to Compare Pharmacokinetics of Two PEG-rhGH Injections With Different Preparations (PHASE1)
- A Clinical Trial to Compare Pharmacokinetics of Two Different PEG-rhGH Preparations (PHASE1)
- A Bioavailability Study of Two Different PEG-rhGH Preparations. (PHASE1)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |