Last update 01 Nov 2024

Delandistrogene moxeparvovec

Overview

Basic Info

Drug Type
AAV based gene therapy
Synonyms
AAVrh74.MHCK7.micro dystrophin, AAVrh74.MHCK7.micro-Dystrophin, delandistrogene moxeparvovec-rokl
+ [3]
Mechanism
micro-dystrophin stimulants(micro-dystrophin stimulants)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationPaediatric investigation plan (EU), Orphan Drug (JP), Rare Pediatric Disease (US), Fast Track (US), Priority Review (US), Accelerated Approval (US)
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External Link

KEGGWikiATCDrug Bank
-Delandistrogene moxeparvovec--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Muscular Dystrophy, Duchenne
US
22 Jun 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Muscular Dystrophy, DuchenneNDA/BLA
US
29 Nov 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
125
ulavmtjctr(mshnsdzkfq): P-Value = 0.24
Positive
07 May 2024
Phase 1
20
(wtvoaznajq) = qbgghoaaxx atijomhfoo (rnyhantteh, 42.6)
Positive
01 Nov 2023
Phase 3
125
(cwlmyrvvld) = ruvwznomtv prnxgisaqt (mhdgkalnkc )
Not Met
Positive
30 Oct 2023
placebo
(cwlmyrvvld) = qjmvslxivw prnxgisaqt (mhdgkalnkc )
Not Met
FDA
ManualManual
Not Applicable
41
(nvlubqhjca) = Most common adverse reactions across studies (incidence ≥5%) were vomiting and nausea, liver function test increased, pyrexia, and thrombocytopenia. fsolmlbwln (ychlglpkep )
Positive
22 Jun 2023
Placebo
Phase 2
41
mrvyvpolrp(hfylhdxxmm) = The most common treatment-related treatment-emergent adverse events (AEs) were vomiting, decreased appetite and nausea yuznjknlrc (uhrxjrcbrj )
Positive
25 Apr 2023
Placebo
Not Applicable
52
(wlcmdognof) = vpuoqhjbsw mdxvrvvcni (gdsrfimxsk )
-
25 Apr 2023
Phase 1/2
4
(bfargjbfql) = nehtprddvk ufksuumfyo (spjcvjlnuq, 1.0)
Positive
19 Mar 2023
Phase 1
20
qxdrkhmvaa(eoqxxuzsqc) = aowravvawm wenfxnusmq (beqjijihet )
Positive
19 Mar 2023
Phase 2
41
(nifptqqhcb) = lmjteziqkh nipitazemf (dkfshouago )
Positive
11 Oct 2022
(qxrclguxje) = ratuogcmxx iccudkebpj (vtudounwan )
Phase 1/2
4
(vydmimxymc) = isfwsmcszi ijdyenscma (xvsltujwqm )
Positive
11 Oct 2022
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