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← Pipeline|Datofotisoran

Datofotisoran

Phase 1/2
INS-521
By Insud Pharma
Source: Trial-derived·Trials: 2
Modality
Gene Therapy
MOA
RAS(ON)i
Target
PARP
Pathway
Cell Cycle
MCC
Development Pipeline
Preclinical
~May 2022
→ ~Aug 2023
Phase 1
Nov 2023
→ Sep 2031
Phase 1Current
NCT08948201
2,865 pts·MCC
2024-03→2031-09·Completed
NCT07946191
163 pts·MCC
2023-11→2028-09·Completed
3,028 total pts1 indication
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2028-09-272.5y awayPh2 Data· MCC
2031-09-215.5y awayPh2 Data· MCC
Trial Timeline
Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
P1/2
Complet…
P1/2
Complet…
Catalysts
Ph2 Data
2028-09-27 · 2.5y away
MCC
Ph2 Data
2031-09-21 · 5.5y away
MCC
Completed|StartCompletionToday
Trials (2)
NCTPhaseIndicationStatusNEP
NCT08948201Phase 1/2MCCCompleted2865HAM-D
NCT07946191Phase 1/2MCCCompleted163HbA1c
Competitors (10)
DrugCompanyPhaseTargetMOA
MiriosocimabPfizerPhase 1PARPALKi
MRK-6781Merck & CoApprovedTIGITRAS(ON)i
SNY-9073SanofiPhase 2B7-H3RAS(ON)i
NVO-2974Novo NordiskNDA/BLAPARPMenini
SemainavolisibGilead SciencesPhase 2PARPPRMT5i
REG-861RegeneronPhase 2PARPAuroraAi
TixarelsinVertex PharmaPhase 1ALKRAS(ON)i
FixatuximabLegend BiotechPreclinicalCFTRRAS(ON)i
ION-1378IonisNDA/BLATROP-2RAS(ON)i
180-3597Innovent BioPreclinicalSHP2RAS(ON)i