← Pipeline|Nidafutibatinib

Nidafutibatinib

NDA/BLA
DTI-3343
Source: Trial-derived·Trials: 1
Modality
Multispecific
MOA
SOS1i
Target
EZH2
Pathway
mTOR
IgANAsthmaFTD
Development Pipeline
Preclinical
~Jun 2017
~Sep 2018
Phase 1
~Dec 2018
~Mar 2020
Phase 2
~Jun 2020
~Sep 2021
Phase 3
~Dec 2021
~Mar 2023
NDA/BLA
Jun 2023
Jan 2029
NDA/BLACurrent
NCT08520516
351 pts·FTD
2023-062029-01·Completed
351 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2029-01-152.8y awayPh3 Readout· FTD
Trial Timeline
Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029
NDA/BLA
Complet…
Catalysts
Ph3 Readout
2029-01-15 · 2.8y away
FTD
Completed|StartCompletionToday
Trials (1)
NCTPhaseIndicationStatusNEP
NCT08520516NDA/BLAFTDCompleted351DOR
Competitors (10)
DrugCompanyPhaseTargetMOA
PFE-2901PfizerPhase 2AHRSOS1i
MRK-1380Merck & CoPreclinicalSHP2SOS1i
TerarelsinAbbViePreclinicalSOS1SOS1i
DoxarapivirBristol-Myers SquibbPhase 3KRASG12CSOS1i
DSN-2247Daiichi SankyoNDA/BLAEZH2C5i
DSN-6862Daiichi SankyoPreclinicalIL-23SOS1i
GIL-2011Gilead SciencesPreclinicalVEGFSOS1i
REG-647RegeneronPreclinicalSMN2SOS1i
CevisacituzumabAlnylamPreclinicalMALT1SOS1i
HAL-9635HalozymePhase 2/3EZH2Cl18.2