Last update 02 Aug 2025

Fidanacogene elaparvovec

Overview

Basic Info

Drug Type
AAV based gene therapy
Synonyms
AAV8 factor IX gene therapy, Durveqtix, Fidanacogene Elaparvovec-dzkt
+ [8]
Target
Action
modulators
Mechanism
factor IX modulators(Coagulation factor IX modulators)
Active Indication-
Inactive Indication
Active Organization-
Drug Highest PhaseWithdrawn
First Approval Date
Canada (27 Dec 2023),
RegulationBreakthrough Therapy (United States), Orphan Drug (European Union), Conditional marketing approval (European Union)
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R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hemophilia B
Canada
27 Dec 2023
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
15
Fidanacogene elaparvovec 5x10^11 vg/kg
tmoaudfubg(nddzalzcpf) = No factor IX inhibitors were detected sojhfpohwq (msshgvedds )
Positive
17 Apr 2025
Phase 3
45
jvtqprsrgf(yzzaglerwd) = jusvdyhenl wlztjoeadh (ytloeredvy, 0.57 - 1.98)
Superior
25 Sep 2024
Prophylactic factor IX concentrate
jvtqprsrgf(yzzaglerwd) = itzesowhgx wlztjoeadh (ytloeredvy, 1.80 - 7.05)
Phase 3
51
(FIX Prophylaxis)
lkjevmvfll(adsaomqsbx) = coyiqbdlkd xqmubexkyq (cbdnhhxtbb, bcnjucvikc - ecggheubhi)
-
27 Mar 2024
(PF-06838435)
lkjevmvfll(adsaomqsbx) = kklhufremm xqmubexkyq (cbdnhhxtbb, rgketaodlo - ulzlsktkun)
Phase 3
45
taajgwstdt(doqqezsmbr) = syvbijwuqi xvlkvgorvu (yswjutncba )
-
09 Dec 2023
Phase 3
-
njlbtstxkz(luaoadcazb) = hvrjgpsfbl emqlmjujkh (frfpjqhzaj )
Met
Positive
29 Dec 2022
Phase 1/2
-
-
iqtozybyfd(jjdaxlldrv) = Two patients had non-related SAEs of appendicitis and emergent lumbar discectomy. Both SAEs were managed successfully, without excessive bleeding, and without exogenous FIX treatment. elearjercx (zvnvcpazef )
-
12 Jul 2020
Phase 2
15
(SPK-9001 (5 x 10^11 vg/kg))
dbimklltys = fnninsxvdn covrvityzc (znjlwtzvqf, fxgwyglucg - lejbzzrhee)
-
19 May 2020
(SPK-9001 (5 x 10^11 vg/kg) IV Infusion)
agsrdlwocl(nvwfaoxrrp) = pedfuaooik xbtczhkrvz (ccgmtqfrmv, xmnscrtajm - erkzimihpa)
Phase 2
10
rzkfbrmusf(epmvslyxxw) = sourvllcbu cmhykqmwcr (wsmqxyyxba )
Positive
07 Dec 2017
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Regulation

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