← Pipeline|Gelifutibatinib

Gelifutibatinib

Approved
JUL-8922
Source: Trial-derived·Trials: 3
Modality
Degrader
MOA
CDK2i
Target
PARP
Pathway
Complement
WMMS
Development Pipeline
Preclinical
~Mar 2010
~Jun 2011
Phase 1
~Sep 2011
~Dec 2012
Phase 2
~Mar 2013
~Jun 2014
Phase 3
~Sep 2014
~Dec 2015
NDA/BLA
~Mar 2016
~Jun 2017
Approved
Sep 2017
Feb 2028
ApprovedCurrent
NCT07857159
1,623 pts·MS
2025-072028-02·Completed
NCT03368160
2,075 pts·WM
2020-04TBD·Completed
NCT04727295
1,424 pts·WM
2017-092025-07·Completed
5,122 total pts2 indications
CompletedCurrentUpcoming
Catalysts (2)
2025-07-258mo agoPh3 Readout· WM
2028-02-201.9y awayPh3 Readout· MS
Trial Timeline
Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2
Approved
Complet…
Approved
Complet…
Approved
Complet…
Catalysts
Ph3 Readout
2025-07-25 · 8mo ago
WM
Ph3 Readout
2028-02-20 · 1.9y away
MS
Completed|StartCompletionToday
Trials (3)
NCTPhaseIndicationStatusNEP
NCT07857159ApprovedMSCompleted1623Safety
NCT03368160ApprovedWMCompleted2075FEV1
NCT04727295ApprovedWMCompleted1424VA
Competitors (10)
DrugCompanyPhaseTargetMOA
PFE-3703PfizerPhase 1/2CDK2CDK2i
MiriosocimabPfizerPhase 1PARPALKi
TirafotisoranRochePhase 2CD38CDK2i
ABB-3951AbbViePhase 2/3TNFαCDK2i
AZN-6870AstraZenecaPhase 2/3EGFRCDK2i
NVO-2974Novo NordiskNDA/BLAPARPMenini
TirasotorasibTakedaNDA/BLAIL-17ACDK2i
MavuglumideBayerApprovedGLP-1RCDK2i
DSN-3066Daiichi SankyoPhase 3IL-13CDK2i
GIL-9227Gilead SciencesPhase 2/3GPRC5DCDK2i