SOGROYA
SOGROYA (somapacitan-beco) is a human growth hormone analog indicated for the treatment of growth hormone deficiency. It is used in pediatric patients aged 2.5 years and older who exhibit growth failure due to inadequate secretion of endogenous growth hormone. In adults, the medication serves as a replacement for endogenous growth hormone in those diagnosed with growth hormone deficiency.
How SOGROYA Works
Somapacitan-beco works by binding to a dimeric growth hormone receptor on the cell membrane of target cells. This interaction initiates intracellular signal transduction, resulting in a variety of pharmacodynamic effects. These effects are achieved either through the direct action of the drug or are mediated by insulin-like growth factor-1 (IGF-1) produced in the liver.
Details
- Status
- Prescription
- First Approved
- 2020-08-28
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
SOGROYA Approval History
What SOGROYA Treats
2 indicationsSOGROYA is approved for 2 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Growth Hormone Deficiency
- Growth Failure
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SOGROYA FDA Label Details
ProIndications & Usage
FDA Label (PDF)SOGROYA is indicated for the: • Treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH). • Replacement of endogenous GH in adults with growth hormone deficiency (GHD). SOGROYA is a human growth hormone analog indicated for: Pediatric Patients: Treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH) . Adults: Replacement of endogenous growth hormone in adults with growth hormone deficiency .
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.