← Pipeline|Darafutibatinib

Darafutibatinib

NDA/BLA
415-3119
Source: Trial-derived·Trials: 1
Modality
Multispecific
MOA
PRMT5i
Target
GPRC5D
Pathway
Sphingolipid
PompeParkinson's
Development Pipeline
Preclinical
~May 2016
~Aug 2017
Phase 1
~Nov 2017
~Feb 2019
Phase 2
~May 2019
~Aug 2020
Phase 3
~Nov 2020
~Feb 2022
NDA/BLA
May 2022
Nov 2030
NDA/BLACurrent
NCT06084571
2,684 pts·Pompe
2022-052030-11·Recruiting
2,684 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2030-11-084.6y awayPh3 Readout· Pompe
Trial Timeline
Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
NDA/BLA
Recruit…
Catalysts
Ph3 Readout
2030-11-08 · 4.6y away
Pompe
Recruiting|StartCompletionToday
Trials (1)
NCTPhaseIndicationStatusNEP
NCT06084571NDA/BLAPompeRecruiting2684OS
Competitors (10)
DrugCompanyPhaseTargetMOA
LLY-6079Eli LillyPhase 2MDM2PRMT5i
RHH-8550RocheApprovedBCL-2PRMT5i
RHH-682RochePhase 2FXIaPRMT5i
PexatenlimabNovartisPhase 1/2GPRC5DKIF18Ai
RibotuximabMerck & CoPhase 2GPRC5DEZH2i
BMY-9931Bristol-Myers SquibbPhase 1GPRC5DFXIai
TalainavolisibNovo NordiskPreclinicalKRASG12DPRMT5i
NVO-7877Novo NordiskPreclinicalGPRC5DFXIai
AMG-9654AmgenPhase 2GPRC5DDLL3 ADC
AMG-4531AmgenPhase 2/3KRASG12CPRMT5i