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Orphan DrugFast TrackBreakthrough TherapyLearn about designations

Approved

Development Phase

1

Upcoming Catalysts

0

Historical Events

1

Regulatory Approvals

Upcoming Catalysts
What are catalysts?
Jul '27
BMRNPDUFA
ApprovedApproved

FDA PDUFA Date Voxzogo

Voxzogo
Jul 2027~
Source
Drug Information

Target Indication

Achondroplasia

Mechanism of Action

C-type Natriuretic Peptide Analog

Clinical Trial

NCT03197766

Last updated: 12/3/2025

Patent & Exclusivity
ActiveRLD

Latest Patent Expiry

Jul 11, 2042(15y 10m)

Patents Listed

8

Exclusivity

NCENPPODE-387ODE-449

Application

NDA 214938
Regulatory Approvals
EMA8/26/2021

Voxzogo

Voxzogo is indicated for the treatment of achondroplasia in patients 4 months of age and older whose epiphyses are not closed. The diagnosis of achondroplasia should be confirmed by appropriate genetic testing.

Orphan
View on EMA
Drug Science
Mechanism of action & safety profile
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