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← Pipeline|ION-1378

ION-1378

NDA/BLA
By Ionis
Source: Trial-derived·Trials: 1
Modality
Gene Editing
MOA
RAS(ON)i
Target
TROP-2
Pathway
T-cell
CSU
Development Pipeline
Preclinical
~Aug 2011
→ ~Nov 2012
Phase 1
~Feb 2013
→ ~May 2014
Phase 2
~Aug 2014
→ ~Nov 2015
Phase 3
~Feb 2016
→ ~May 2017
NDA/BLA
Aug 2017
→ Apr 2025
NDA/BLACurrent
NCT06518908
2,722 pts·CSU
2017-08→2025-04·Terminated
2,722 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2025-04-2411mo agoPh3 Readout· CSU
Trial Timeline
Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2
NDA/BLA
Termina…
Catalysts
Ph3 Readout
2025-04-24 · 11mo ago
CSU
Terminated|StartCompletionToday
Trials (1)
NCTPhaseIndicationStatusNEP
NCT06518908NDA/BLACSUTerminated2722VA
Competitors (10)
DrugCompanyPhaseTargetMOA
NVS-4076NovartisPreclinicalTROP-2DLL3 ADC
NVS-8902NovartisPreclinicalTROP-2IL-13i
MRK-6781Merck & CoApprovedTIGITRAS(ON)i
SNY-9073SanofiPhase 2B7-H3RAS(ON)i
ZanumavacamtenGSKPhase 2/3TROP-2BTKi
TixarelsinVertex PharmaPhase 1ALKRAS(ON)i
FixatuximabLegend BiotechPreclinicalCFTRRAS(ON)i
NirafotisoranJazz PharmaPhase 2/3TROP-2SHP2i
180-3597Innovent BioPreclinicalSHP2RAS(ON)i
ILM-4317IlluminaNDA/BLATROP-2STINGag