← Pipeline|Niralemzoparlimab

Niralemzoparlimab

Phase 2/3
GEN-3650
Source: Trial-derived·Trials: 2
Modality
siRNA
MOA
MDM2i
Target
SOS1
Pathway
Apoptosis
HNSCCHemophilia APBC
Development Pipeline
Preclinical
~May 2020
~Aug 2021
Phase 1
~Nov 2021
~Feb 2023
Phase 2
May 2023
Nov 2031
Phase 2Current
NCT03659567
1,525 pts·Hemophilia A
2024-022031-03·Terminated
NCT03518009
1,387 pts·HNSCC
2023-052031-11·Active
2,912 total pts2 indications
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2031-03-165.0y awayPh3 Readout· Hemophilia A
2031-11-075.6y awayPh3 Readout· HNSCC
Trial Timeline
Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
P2/3
Active
P2/3
Termina…
Catalysts
Ph3 Readout
2031-03-16 · 5.0y away
Hemophilia A
Ph3 Readout
2031-11-07 · 5.6y away
HNSCC
ActiveTerminated|StartCompletionToday
Trials (2)
NCTPhaseIndicationStatusNEP
NCT03659567Phase 2/3Hemophilia ATerminated1525EASI-75
NCT03518009Phase 2/3HNSCCActive1387DOR
Competitors (10)
DrugCompanyPhaseTargetMOA
DoxacapivasertibEli LillyPhase 3APOC3MDM2i
TerarelsinAbbViePreclinicalSOS1SOS1i
RibofutibatinibAstraZenecaPhase 2/3SOS1PCSK9i
BMY-8678Bristol-Myers SquibbApprovedRETMDM2i
AMG-415AmgenPhase 1CDK2MDM2i
VoxacageneGilead SciencesPhase 2/3SOS1TYK2i
GIL-2037Gilead SciencesApprovedKRASG12DMDM2i
CapiglumideBioNTechPreclinicalCGRPMDM2i
SRP-9822SareptaPhase 3SOS1FGFRi
RimasertibExelixisPhase 3B7-H3MDM2i