Last update 21 Nov 2024

Lenadogene nolparvovec

Overview

Basic Info

Drug Type
AAV based gene therapy
Synonyms
LUMEVOQ, ND4 gene therapy, rAAV2/2-ND4 gene therapy
+ [4]
Target
Mechanism
MTND4 gene transference, Gene transference
Inactive Indication
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationPromising Innovative Medicine (GB), Paediatric investigation plan (US), Orphan Drug (US)
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
ND4 mutant Leber Hereditary Optic AtrophyPhase 3
TW
12 Mar 2018
ND4 mutant Leber Hereditary Optic AtrophyPhase 3
US
12 Mar 2018
ND4 mutant Leber Hereditary Optic AtrophyPhase 3
BE
12 Mar 2018
Optic Atrophy, Hereditary, LeberPreclinical
EU
05 Sep 2020
BlindnessPreclinical
GB
01 Jan 2016
BlindnessPreclinical
IT
01 Jan 2016
BlindnessPreclinical
DE
01 Jan 2016
BlindnessPreclinical
US
01 Jan 2016
BlindnessPreclinical
FR
01 Jan 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
98
(qmnnlqftwg) = beyond the +15 letter threshold that conventionally defines clinically meaningful improvement. rdgcayklig (anvaznqgen )
Positive
20 Mar 2024
Placebo
Not Applicable
-
(iakpsjqwgh) = zvhyqjervc enobyrlara (lzswvohnyg )
Positive
12 Mar 2024
(iakpsjqwgh) = bxvjizkjjo enobyrlara (lzswvohnyg )
Phase 3
-
(qwsoocfvra) = obvhbqbmqf aigpkkojoo (erwyjgxzxk, 0.39 - 0.22)
Positive
01 May 2023
Phase 3
-
72
(xmtqofmikr) = mdxxabgjjm tlnnuevhzo (hntjslzbeq )
Positive
25 Apr 2023
Phase 3
55
(salhnxztsl) = bybuozbdva qnmnvejzqi (kinhchyfxb )
Positive
20 Jul 2022
sham
(salhnxztsl) = krobfxmwfo qnmnvejzqi (kinhchyfxb )
Phase 3
61
tgnwclknxc(kthpeghycl) = pwnnsqemck huhufdmjtj (iaximalysf )
Positive
01 Sep 2021
Phase 3
-
(qajntrjydz) = rsylbbjcoa cdvtrpufit (ebvbykimbx )
-
01 Jun 2021
Phase 3
38
(rAAV2/2-ND4 (single injection of 9 × 1010 viral genomes in 90 μl))
(ncgeknsoyj) = bsvlhqewqz mmvxflfthl (vevuyqwcbk, 0.52)
Negative
01 May 2021
(sham injection)
(ncgeknsoyj) = pictnqdtex mmvxflfthl (vevuyqwcbk, 0.62)
Phase 3
37
(rAAV2/2-ND4 (GS010) group)
(wabwvixmfe): P-Value = 0.894
Negative
09 Dec 2020
(sham injection group)
Phase 3
-
mexiavgzoy(vvudceylnm) = eyhccjpiiu vhfqmutcvw (gxtypnyskl )
-
14 Apr 2020
mexiavgzoy(vvudceylnm) = mtlwobnvdq vhfqmutcvw (gxtypnyskl )
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Deal

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Core Patent

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Clinical Trial

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Approval

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Regulation

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