← Pipeline|Kemafutibatinib

Kemafutibatinib

Phase 3
ORB-4844
Source: Trial-derived·Trials: 4
Modality
Peptide
MOA
CDK4/6i
Target
CD38
Pathway
Neuroinflam
DLBCL
Development Pipeline
Preclinical
~Oct 2017
~Jan 2019
Phase 1
~Apr 2019
~Jul 2020
Phase 2
~Oct 2020
~Jan 2022
Phase 3
Apr 2022
Sep 2029
Phase 3Current
NCT07412405
2,250 pts·DLBCL
2023-082025-11·Recruiting
NCT08091723
532 pts·DLBCL
2022-042029-09·Active
NCT05660745
1,192 pts·DLBCL
2024-022025-12·Recruiting
+1 more trial
6,785 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (3)
2025-11-274mo agoPh3 Readout· DLBCL
2025-12-193mo agoPh3 Readout· DLBCL
2029-09-173.5y awayPh3 Readout· DLBCL
Trial Timeline
Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q4
P3
Active
P3
Recruit…
P3
Recruit…
P3
Recruit…
Catalysts
Ph3 Readout
2025-11-27 · 4mo ago
DLBCL
Ph3 Readout
2025-12-19 · 3mo ago
DLBCL
Ph3 Readout
2029-09-17 · 3.5y away
DLBCL
RecruitingActive|StartCompletionToday
Trials (4)
NCTPhaseIndicationStatusNEP
NCT07412405Phase 3DLBCLRecruiting2250DAS28
NCT08091723Phase 3DLBCLActive532UPCR
NCT05660745Phase 3DLBCLRecruiting1192PFS
NCT05047764Phase 3DLBCLRecruiting2811BodyWt
Competitors (10)
DrugCompanyPhaseTargetMOA
PFE-5767PfizerPhase 1/2BETCDK4/6i
TerafutibatinibPfizerPhase 1/2CD38CGRPant
RHH-1969RocheApprovedBETCDK4/6i
TirafotisoranRochePhase 2CD38CDK2i
NVS-6360NovartisApprovedCD38FXIai
DoxasotorasibAbbViePhase 2CD38VEGFi
IvocapivasertibBristol-Myers SquibbPhase 1BETCDK4/6i
ZorimavacamtenBristol-Myers SquibbPreclinicalCl18.2CDK4/6i
SNY-2289SanofiPhase 2/3CD38IL-17i
NVO-1361Novo NordiskPhase 3CD38CD3xCD20