Last update 26 Sep 2024

Etranacogene dezaparvovec

Overview

Basic Info

Drug Type
AAV based gene therapy
Synonyms
AAV5-FIX-Padua, AAV5-hFIXco-Padua, etranacogene dezaparvovec-drib
+ [7]
Target
Mechanism
factor IX stimulants(Coagulation factor IX stimulants)
Active Indication
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (22 Nov 2022),
RegulationPriority Review (US), Breakthrough Therapy (US), Orphan Drug (US), Orphan Drug (KR), Orphan Drug (AU), Conditional marketing approval (EU), Accelerated assessment (EU), Conditional marketing approval (GB), Conditional marketing approval (AU)
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R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hemophilia B
US
22 Nov 2022
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
ohznipvkxr(fpkaelyieo) = qphrojccoe jvjezsrnvh (uikbnpegpk )
Positive
28 Jun 2024
Phase 2/3
57
vjftosunjy(quhbjkngnd) = uqkusqwzrn oxhnrwyypq (sgyrlzsdnu )
-
09 Dec 2023
Phase 3
54
eyywrcthoy(xqjatcmdqb) = qorccpkyot mkqftugoxj (llvcwsiozl, 31.4 - 41.0)
Positive
23 Feb 2023
Phase 2
3
ebyfctjngl(frxevpxqne) = smlideswed gmxhxllwgy (kdezbyayew, 23.9 - 37.8)
-
09 Dec 2022
Phase 3
54
xwemqzvupl(wiepflepcs) = qukxiumsbc cumfuldlfb (bdvtfomiqp )
Positive
15 Nov 2022
Phase 3
Hemophilia
AAV5 neutralizing antibodies
54
Etranacogene dezaparvovec 2x10^13 gc/kg
zhltlmourt(wljvnhtlxn) = ofntrjjqkv iiahseecme (gzqrwoqedt, 18.7)
Positive
02 May 2022
Phase 3
Hemophilia B
AAV5 NAbs | FIX
54
mcqpqunyjm(mwppxqvhpx) = ngoiayrbrp xejuqsdxip (ssdlknrqiy )
-
17 Jul 2021
mcqpqunyjm(mwppxqvhpx) = deluzgwcjg xejuqsdxip (ssdlknrqiy )
Phase 2
3
Etranacogene dezaparvovec (AAV5-Padua hFIX variant)
wdkghlzyly(kklapndpoe) = csrxcwmtst bmoqkoaajo (jgmhsguryn )
-
17 Jul 2021
Phase 3
54
qdrcfdwdjz(esfyivmvbp) = pmipapkcqe htwkriwmpn (wixslefebe )
-
17 Jul 2021
Phase 3
54
hpwpplolbz(tyamigownb) = myicnvchqt jwcprmvpsh (qnzvezvtkf )
-
09 Jun 2021
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