vosoritide

Trade name: Voxzogo

PeptideapprovedOrphan Drug FDA

Approved

Nov 19, 2021

Vosoritide, sold under the brand name Voxzogo, is a medication used for the treatment of achondroplasia, a genetic condition that causes severely short stature and disproportionate growth. — Wikipedia

Clinical trial activity

8 trials · 4 clinical orgs · 1 marketing orgs

Phase 1
0
Phase 2
8
Phase 3
2
Phase 4
0

Earliest trial started May 1, 2020 (NCT04219007)

Timeline

2010s

  1. Jan 17, 2013

    Orphan Drug Designation

2020s

  1. Jan 1, 2020

    Earliest Phase 2 Sponsor(trial)

  2. Nov 19, 2021

    Biomarin — Earliest FDA Approval

  3. Nov 19, 2021

    Biomarin — Marketing Organization

  4. Nov 19, 2021

    Biomarin — NDA Secondary Org

  5. Nov 19, 2021

    Biomarin — NDA Organization

  6. Jan 1, 2024

    Biomarin — Earliest Phase 3 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedNov 19, 2021

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

First in class

Sources

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07126262Phase 2Jul 30, 2025Biomarin, ICON
NCT07073014Phase 3Jun 20, 2025Biomarin
NCT06668805Phase 2Nov 30, 2024Biomarin
NCT06382155Phase 2Sep 30, 2024Biomarin
NCT05849389Phase 2Jul 31, 2024Georgetown University
NCT06455059Phase 3Jun 1, 2024Biomarin
NCT04554940Phase 2Oct 10, 2020Biomarin
NCT04219007Phase 2May 1, 2020Children's National Medical Center
Showing 8 of 8 trials
Page 1 / 1

Organizations

Research & Development (4)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
BiomarinFor profit6622020
Children's National Medical CenterAcademic/Hospital1112020
Georgetown UniversityAcademic/Hospital1112024
ICONFor profit1012025
4 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
BiomarinFor profitMKTGNov 19, 2021
BiomarinFor profitNDA2Nov 19, 2021
BiomarinFor profitNDANov 19, 2021