Drugs / Vosoritide

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) VOXZOGO 2023-10-20 fda.gov
Approved US (FDA) VOXZOGO 2021-11-19 fda.gov
Approved EU (EMA) Voxzogo 2021-08-26 europa.eu

Trials 15 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT05845749 Sep 2023 → Dec 2028 expected mucopolysaccharidosis type 4A, mucopolysaccharidosis type 6 University of California, San Francisco Active not recruiting No outcome recorded
Phase 210 trials
Phase 2 NCT07126262 Jul 2025 → Jun 2028 expected hypochondroplasia BioMarin Pharmaceutical Recruiting No outcome recorded
Phase 2 NCT06668805 Nov 2024 → Mar 2027 expected Noonan syndrome BioMarin Pharmaceutical Recruiting No outcome recorded
Phase 2 NCT06382155 Oct 2024 → Jun 2026 overdue isolated short stature BioMarin Pharmaceutical Recruiting No outcome recorded
Phase 2 NCT05849389 Apr 2024 → Sep 2026 expected Turner syndrome, isolated short stature Roopa Kanakatti Shankar, MBBS, MS Recruiting No outcome recorded
Phase 2 NCT04554940 Oct 2020 → Dec 2027 expected achondroplasia BioMarin Pharmaceutical Active not recruiting No outcome recorded
Phase 2 NCT04219007 Aug 2020 → Aug 2025 overdue Andrew Dauber Active not recruiting No outcome recorded
Phase 2 NCT03989947 Jun 2019 → May 2038 expected achondroplasia BioMarin Pharmaceutical Active not recruiting No outcome recorded
Phase 2 NCT03583697 Jun 2018 → Jan 2022 achondroplasia BioMarin Pharmaceutical Completed No outcome recorded
Phase 2 NCT02724228 Jan 2016 → Dec 2027 expected achondroplasia BioMarin Pharmaceutical Active not recruiting No outcome recorded
Phase 2 NCT02055157 Jan 2014 → Oct 2017 achondroplasia BioMarin Pharmaceutical Completed No outcome recorded
Phase 34 trials
Phase 3 NCT07073014 Jun 2025 → Dec 2040 expected hypochondroplasia BioMarin Pharmaceutical Enrolling by invitation No outcome recorded
Phase 3 NCT06455059 Jun 2024 → Aug 2026 overdue hypochondroplasia BioMarin Pharmaceutical Active not recruiting No outcome recorded
Phase 3 NCT03424018 Dec 2017 → Jun 2031 expected achondroplasia BioMarin Pharmaceutical Active not recruiting No outcome recorded
Phase 3 NCT03197766 Dec 2016 → Oct 2019 achondroplasia BioMarin Pharmaceutical Completed No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT01590446 Comparator Feb → Jun 2012 achondroplasia BioMarin Pharmaceutical Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT07441876 Comparator Apr 2026 → Jun 2029 expected achondroplasia BioMarin Pharmaceutical Recruiting No outcome recorded

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 18 sources stand behind the page.

FieldValueCited text
Known as Vosoritide ClinicalTrials.gov intervention name — accepted as the source's own label NCT07441876
9

NCT04554940

NCT05845749

NCT06455059

NCT04219007

NCT06668805

NCT07126262

NCT06382155

NCT05849389

NCT07073014

Known as BMN 111 ClinicalTrials.gov intervention name — accepted as the source's own label NCT01590446
6

NCT02055157

NCT02724228

NCT03197766

NCT03989947

NCT03424018

NCT03583697

Known as Modified C-Natriuretic Peptide Modified C-Natriuretic Peptide, ProCNP38” NCT01590446
Known as ProCNP38 “Modified C-Natriuretic Peptide, ProCNP38NCT01590446
Known as Vosoritida ChEMBL registry synonym — accepted as the source's own label CHEMBL3707276
Known as Vosoritide Injection “Drug: Vosoritide InjectionNCT06668805
1

“Drug: Vosoritide InjectionNCT06382155

Known as Voxzogo “Drug: Vosoritide Injection [Voxzogo]” NCT05845749
1

“Vosoritide Injection [Voxzogo]” NCT07441876

Action Activate “a selective NPR-B agonist” NCT04219007
Modality Peptide “Modified recombinant human C-type natriuretic peptideNCT03989947
Route Subcutaneous “SC injection, Part 1 single dose and Part 2 multiple dose.” NCT01590446
Target NPR2 “Atrial natriuretic peptide receptor B binding agent” CHEMBL3707276