VOXZOGO
VOXZOGO (vosoritide) is a C-type natriuretic peptide (CNP) analog indicated to increase linear growth in pediatric patients with achondroplasia who have open epiphyses. The drug received accelerated approval based on demonstrated improvements in annualized growth velocity. Continued approval for this indication may be contingent upon the verification and description of clinical benefit in confirmatory trials.
How VOXZOGO Works
In patients with achondroplasia, endochondral bone growth is negatively regulated by a gain-of-function mutation in fibroblast growth factor receptor 3 (FGFR3). Vosoritide binds to natriuretic peptide receptor-B (NPR-B), which antagonizes FGFR3 downstream signaling by inhibiting the ERK1/2 and MAPK pathways. This inhibition promotes chondrocyte proliferation and differentiation, acting as a positive regulator of endochondral bone growth to increase skeletal growth.
Details
- Status
- Prescription
- First Approved
- 2021-11-19
- Routes
- SUBCUTANEOUS
- Dosage Forms
- POWDER
VOXZOGO Approval History
What VOXZOGO Treats
1 indicationsVOXZOGO is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Achondroplasia
VOXZOGO Competitors
Pro6 other drugs also target FGFR3. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (FGFR3). Earlier expiry dates signal biosimilar/generic opportunities.
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.
VOXZOGO FDA Label Details
ProIndications & Usage
FDA Label (PDF)VOXZOGO is indicated to increase linear growth in pediatric patients with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity [see Clinical Studies ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). VOXZOGO is a C type natriuretic peptide (CNP) analog indicated to increase linear growth in pediatric patients with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an...
VOXZOGO Patents & Exclusivity
Patents (72 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.