Last update 01 Nov 2024

DTX-301

Overview

Basic Info

Drug Type
AAV based gene therapy
Synonyms
Avalotcagene ontaparvovec, OTC-gene-therapy-Dimension-Therapeutics, Ornithine-transcarbamylase-gene-therapy-Dimension-Therapeutics
+ [2]
Target
Mechanism
OTC gene transference
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
Regulation-
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Ornithine Carbamoyltransferase Deficiency DiseasePhase 3
US
18 Oct 2022
Ornithine Carbamoyltransferase Deficiency DiseasePhase 3
DE
18 Oct 2022
Ornithine Carbamoyltransferase Deficiency DiseasePhase 3
PT
18 Oct 2022
Ornithine Carbamoyltransferase Deficiency DiseasePhase 3
CA
18 Oct 2022
Ornithine Carbamoyltransferase Deficiency DiseasePhase 3
FR
18 Oct 2022
Ornithine Carbamoyltransferase Deficiency DiseasePhase 3
ES
18 Oct 2022
Ornithine Carbamoyltransferase Deficiency DiseasePhase 3
JP
18 Oct 2022
Ornithine Carbamoyltransferase Deficiency DiseasePhase 3
GB
18 Oct 2022
Ornithine Carbamoyltransferase Deficiency DiseasePhase 3
BR
18 Oct 2022
Ornithine Carbamoyltransferase Deficiency DiseasePhase 3
IT
18 Oct 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
11
robmqpopiq(lujpgphlzq) = hohistxkgz zcakbuneik (msdvrocpms )
Positive
07 May 2024
Phase 1/2
11
pnoawyofws(pxvidkuduv) = zsoplmxvzf pvnyvcbcqk (uhpcqsbbxk )
-
30 Aug 2023
Phase 1/2
16
Reactive Corticosteroid Taper Regimen+scAAV8OTC
(Cohort 1: DTX301 2.0 × 10^12 GC/kg)
ejgtjwdtia(gtkjtfqsmw) = rwzilkumrz ayppntijpb (kuotyzyxeq, xxisvvedha - srjakohpnh)
-
23 Dec 2022
Reactive Corticosteroid Taper Regimen+scAAV8OTC
(Cohort 2: DTX301 6.0 × 10^12 GC/kg)
ejgtjwdtia(gtkjtfqsmw) = kuvhnnqbyt ayppntijpb (kuotyzyxeq, qzjbeiheyv - jvfszwuyto)
Phase 1/2
-
potyzvvild(ymnipqyorf) = vhdmrkektx zentwsfqgc (nsnkgtuisa )
-
30 Aug 2022
Phase 1/2
11
DTX301 3.4x10^12 GC/kg
izyaqflgqz(dmastjngox) = All AEs during study were mild or moderate (grade 1 or 2), with the exception of one patient with grade 3 hyperammonemic crises, assessed as related to OTC deficiency and unrelated to DTX301, oral corticosteroids, or study procedures niudltmcyf (wmhxugnghs )
Positive
02 May 2022
DTX301 1.0x10^13 GC/kg
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Approval

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Regulation

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