Vosoritide

For achondroplasia with open epiphyses. Sold as Voxzogo. Every FDA application for this active ingredient.

As of Nov 13, 2026, FDA lists 1 application for Vosoritide (sold as Voxzogo), first approved Nov 19, 2021, with 1 new use approved and 0 published complete response letters.

First approved: Nov 19, 2021
Applications: 1
New uses approved: 1
Complete response letters: 0

Clinical Trials

10 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Study to Evaluate the Efficacy and Safety of BMN 333 Versus Vosoritide in Children With AchondroplasiaAchondroplasia · BioMarin Pharmaceutical	Phase 2 / Phase 3	Recruiting	Mar 2, 2026
A Study of Vosoritide Versus Placebo in Children With Hypochondroplasia Aged 0 to < 36 MonthsHypochondroplasia · BioMarin Pharmaceutical	Phase 2	Recruiting	Aug 17, 2025
Long-Term Extension Study of Vosoritide to Treat Children With HypochondroplasiaHypochondroplasia · BioMarin Pharmaceutical	Phase 3	Enrolling by invitation	Jul 18, 2025
A Phase 2 Study of Vosoritide in Children With Idiopathic Short StatureIdiopathic Short Stature · BioMarin Pharmaceutical	Phase 2	Recruiting	Apr 24, 2024
Safety and Efficacy of Voxzogo for Growth Deficits in MPS IVA and VIMPS IVA, MPS VI · University of California, San Francisco	Phase 1 / Phase 2	Active, not recruiting	May 6, 2023
A Clinical Trial to Evaluate Safety of Vosoritide in At-risk Infants With AchondroplasiaAchondroplasia · BioMarin Pharmaceutical	Phase 2	Active, not recruiting	Sep 18, 2020
Vosoritide for Selected Genetic Causes of Short StatureShort Stature · Andrew Dauber	Phase 2	Active, not recruiting	Jan 6, 2020
An Extension Study to Evaluate Safety and Efficacy of BMN 111 in Children With AchondroplasiaAchondroplasia · BioMarin Pharmaceutical	Phase 2	Active, not recruiting	Jun 18, 2019

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Nov 19, 2021	VoxzogoNDA 214938 · New molecular entity	Biomarin Pharm	2	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA