Last update 28 Mar 2025

Vosoritide

Overview

Basic Info

Drug Type
Recombinant polypeptide
Synonyms
Modified C-natriuretic peptide, Modified recombinant human C-type natriuretic peptide, Vosoritide (genetical recombination) (JAN)
+ [6]
Target
Action
agonists
Mechanism
NPRB agonists(Atrial natriuretic peptide receptor type B agonists)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
European Union (26 Aug 2021),
RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (Australia), Priority Review (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11190Vosoritide-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Achondroplasia
European Union
26 Aug 2021
Achondroplasia
Iceland
26 Aug 2021
Achondroplasia
Liechtenstein
26 Aug 2021
Achondroplasia
Norway
26 Aug 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HypochondroplasiaNDA/BLA
Canada
01 Feb 2025
Noonan SyndromePhase 2
United States
22 Nov 2024
Short Stature Homeobox DeficiencyPhase 2
United States
22 Nov 2024
Idiopathic short staturePhase 2
United States
21 Oct 2024
Turner SyndromePhase 2
United States
12 Apr 2024
DwarfismPhase 2
United States
04 Aug 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
-
kyklkcreez(jhwzqnckhs) = xheqfwxexx fdrjstujqg (qbrnrrpzyy, 0.46 - 1.93)
Positive
20 Oct 2023
Phase 2
34
atlngvhftz(zqprqfgqms) = fscgvnrmli vvgbwwaxcj (uvqllokrdx, 2.98 - 9.56)
Positive
21 Sep 2023
Phase 2
35
Vosoritide 15 mcg/kg/day
yrqrofxlrd(pwbodmkkir) = kfwexfewua eavenvwfmo (puanjgeygk, 2.2 - 4.6)
Positive
01 Nov 2022
Phase 2
26
netyikpcde(iefbujjocw) = wcmiapqzmv gryexkonbw (apcifbjafe, 6.8 - 8)
-
15 Sep 2022
Not Applicable
29
flqnqczmbl(obuwcqispm) = The majority of AEs were mild and included injection site reactions and vomiting, with the most common being injection site rash (4 events) ppmgmycrsp (jjmoengypp )
Positive
15 Sep 2022
Phase 2
Diabetic macular oedema | Noonan Syndrome
NPR2 mutations | PTPN11 mutations
6
Vosoritide 15 mg/kg/day
ubmxvoawel(tfftyhytjs) = pculahmnag bhztqllihc (qfnrftswhl )
Positive
15 Sep 2022
Phase 2
75
mufiqtxhoh(hhoneouldn) = azcpajwqma gtyrcaztrv (vqhqlegtjy, 0.07 - 0.54)
Positive
13 Jun 2022
Placebo
huapuvnero(xtjbwmvdqp) = jphtcqopge nqrenjopix (uqmsxtzjtb )
Phase 3
121
Placebo
amktujstup(mjmqvpkdpa) = msjdxndxqm cwnyvfcdjh (qdrhdegova, uwghxogbdd - zdseoszrsr)
-
02 Mar 2022
Phase 3
119
sqokvaunit(mhxuymtkbz) = eavmbnixzw hzujfkdsqm (keoqxagvur )
Positive
01 Dec 2021
Placebo
sqokvaunit(mhxuymtkbz) = jrcwnlvohu hzujfkdsqm (keoqxagvur )
Phase 3
121
qmusuauxgx(zkfandotma): difference = 1.57 (95% CI, 1.22 - 1.93), P-Value = <0.0001
Positive
05 Sep 2020
Placebo
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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