← Pipeline|Nirafutibatinib

Nirafutibatinib

Phase 2
BAY-947
Source: Trial-derived·Trials: 2
Modality
Cell Therapy
MOA
PD-L1i
Target
WRN
Pathway
Complement
ThymomaSMAWilms
Development Pipeline
Preclinical
~Feb 2014
~May 2015
Phase 1
~Aug 2015
~Nov 2016
Phase 2
Feb 2017
Nov 2025
Phase 2Current
NCT03264682
225 pts·SMA
2017-072025-11·Not yet recruiting
NCT04024495
114 pts·Wilms
2017-02TBD·Active
339 total pts2 indications
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2025-11-224mo agoPh2 Data· SMA
Trial Timeline
2017Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q4
P2
Active
P2
Not yet…
Catalysts
Ph2 Data
2025-11-22 · 4mo ago
SMA
ActiveNot yet recruiting|StartCompletionToday
Trials (2)
NCTPhaseIndicationStatusNEP
NCT03264682Phase 2SMANot yet recr...225PASI75
NCT04024495Phase 2WilmsActive1146MWD
Competitors (10)
DrugCompanyPhaseTargetMOA
PFE-1085PfizerPreclinicalFXIaPD-L1i
RilulemzoparlimabNovartisPhase 2/3KRASG12DPD-L1i
MRK-3745Merck & CoPhase 2WRNFXIai
ZorisotorasibAstraZenecaPhase 1WRNTYK2i
BMY-3371Bristol-Myers SquibbPhase 3WRNBTKi
SNY-9600SanofiNDA/BLAB7-H3PD-L1i
LisorapivirTakedaPreclinicalWRNBTKi
MotainavolisibAmgenNDA/BLACD47PD-L1i
BNT-8090BioNTechPhase 2AuroraAPD-L1i
MiriglumideAlnylamPhase 3CD3PD-L1i