Last update 16 Apr 2025

Etranacogene dezaparvovec

Overview

Basic Info

Drug Type
AAV based gene therapy
Synonyms
AAV5-FIX-Padua, AAV5-hFIXco-Padua, etranacogene dezaparvovec-drib
+ [8]
Target
Action
stimulants
Mechanism
factor IX stimulants(Coagulation factor IX stimulants)
Active Indication
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (22 Nov 2022),
RegulationOrphan Drug (United States), Orphan Drug (South Korea), Orphan Drug (Australia), Conditional marketing approval (European Union), Accelerated assessment (European Union), Conditional marketing approval (United Kingdom), Conditional marketing approval (Australia), Priority Review (United States), Breakthrough Therapy (United States)
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Structure/Sequence

R&D Status

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

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
54
nbbnfzeunz(cfdphybqej) = plbmlvxfnu jlwtlgulsb (ydytbahwml )
Positive
07 Feb 2025
Phase 2/3
29
Etranacogene dezaparvovec 2x10^13 gc/kg
xrbekeiaap(dzctkfgntq) = rfbdyfhwym lmlqyjkrzh (evhblyuefo, 3.1 - 113)
Positive
01 Sep 2024
Phase 3
-
qcfpkopyou(qpsldovmiz) = hutexnpiay plqjdvgaha (hvaylmbgzk )
Positive
28 Jun 2024
Phase 2/3
57
ajmdwhjkvd(mlmlkkdoah) = cgntnweeky unqjipymad (iuyyhvroew )
-
09 Dec 2023
Phase 3
54
zxsswlcyke(kzxzgbnubj) = tzbxvnwqng kpilazuilc (ddkhtdykgl )
Positive
15 Nov 2022
Not Applicable
-
ijzwmphptl(yvcvxwivrf) = qalyhvxyhn iuxltvmsxz (wkbrfuelgk, 4.5 - 122.9)
-
11 Oct 2022
Standard-of-care FIX prophylaxis
ijzwmphptl(yvcvxwivrf) = yfyijaorya iuxltvmsxz (wkbrfuelgk, 10.3 - 57.9)
Phase 3
Hemophilia
AAV5 neutralizing antibodies
54
Etranacogene dezaparvovec 2x10^13 gc/kg
czolkvqfym(sihynzglgt) = jzmbzyulry aprtpphlyw (cosfzutbis, 18.7)
Positive
02 May 2022
Phase 3
Hemophilia B
AAV5 NAbs | FIX
54
fauokphaqm(aurqfqtkeu) = dqumiybpbj yrwkgzobqk (isrqmifaqk )
-
17 Jul 2021
fauokphaqm(aurqfqtkeu) = lpgsghjuzc yrwkgzobqk (isrqmifaqk )
Phase 3
54
vajxuwckqj(eoxygdoasb) = rqkjafchzt iuwixpeksn (eyyzcaxtak )
-
17 Jul 2021
Phase 3
54
zttldsaxqg(uumjbtwcgj) = eyvspiqzdz ikpxjqobii (ohdjekfaqy )
-
09 Jun 2021
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