← Pipeline|488-6595

488-6595

Approved
Source: Trial-derived·Trials: 4
Modality
Bispecific Ab
MOA
TYK2i
Target
CDK4/6
Pathway
Neuroinflam
GISTGBM
Development Pipeline
Preclinical
~Feb 2010
~May 2011
Phase 1
~Aug 2011
~Nov 2012
Phase 2
~Feb 2013
~May 2014
Phase 3
~Aug 2014
~Nov 2015
NDA/BLA
~Feb 2016
~May 2017
Approved
Aug 2017
Jun 2031
ApprovedCurrent
NCT04076541
1,441 pts·GBM
2017-082030-07·Terminated
NCT03692708
2,588 pts·GIST
2023-022026-02·Terminated
NCT07193452
2,027 pts·GBM
2019-012031-06·Completed
+1 more trial
8,959 total pts2 indications
CompletedCurrentUpcoming
Catalysts (4)
2025-08-098mo agoPh3 Readout· GBM
2026-02-181mo agoPh3 Readout· GIST
2030-07-124.3y awayPh3 Readout· GBM
2031-06-175.2y awayPh3 Readout· GBM
Trial Timeline
Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3
Approved
Termina…
Approved
Complet…
Approved
Termina…
Approved
Active
Catalysts
Ph3 Readout
2025-08-09 · 8mo ago
GBM
Ph3 Readout
2026-02-18 · 1mo ago
GIST
Ph3 Readout
2030-07-12 · 4.3y away
GBM
Ph3 Readout
2031-06-17 · 5.2y away
GBM
ActiveCompletedTerminated|StartCompletionToday
Trials (4)
NCTPhaseIndicationStatusNEP
NCT04076541ApprovedGBMTerminated1441Safety
NCT03692708ApprovedGISTTerminated2588Safety
NCT07193452ApprovedGBMCompleted2027DOR
NCT06755422ApprovedGBMActive2903MRD
Competitors (10)
DrugCompanyPhaseTargetMOA
NidasacituzumabEli LillyApprovedCFTRTYK2i
LisonaritideEli LillyPhase 3IL-13TYK2i
MRK-2473Merck & CoPhase 1/2Nectin-4TYK2i
ZorisotorasibAstraZenecaPhase 1WRNTYK2i
SNY-8628SanofiNDA/BLAB7-H3TYK2i
MotavorutinibAmgenPhase 3CDK4/6JAK1/2i
VoxacageneGilead SciencesPhase 2/3SOS1TYK2i
RibozanubrutinibRegeneronPhase 1CDK4/6IL-13i
SotosacituzumabVertex PharmaPhase 1METTYK2i
SotorapivirModernaApprovedFLT3TYK2i