← Pipeline|Datobrutinib

Datobrutinib

Phase 3
SNY-4465
Source: Trial-derived·Trials: 4
Modality
mAb
MOA
HER2
Target
Pathway
Angiogenesis
FTDEpilepsy
Development Pipeline
Preclinical
~Oct 2015
~Jan 2017
Phase 1
~Apr 2017
~Jul 2018
Phase 2
~Oct 2018
~Jan 2020
Phase 3
Apr 2020
Jul 2028
Phase 3Current
NCT06911553
1,538 pts·Epilepsy
2021-112025-03·Recruiting
NCT03343567
2,811 pts·FTD
2024-122027-07·Terminated
NCT05455573
2,862 pts·FTD
2024-102028-07·Completed
+1 more trial
9,847 total pts2 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (4)
2025-03-051.1y agoPh3 Readout· Epilepsy
2027-02-0510mo awayPh3 Readout· FTD
2027-07-071.3y awayPh3 Readout· FTD
2028-07-152.3y awayPh3 Readout· FTD
Trial Timeline
Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3
P3
Not yet…
P3
Recruit…
P3
Complet…
P3
Termina…
Catalysts
Ph3 Readout
2025-03-05 · 1.1y ago
Epilepsy
Ph3 Readout
2027-02-05 · 10mo away
FTD
Ph3 Readout
2027-07-07 · 1.3y away
FTD
Ph3 Readout
2028-07-15 · 2.3y away
FTD
RecruitingCompletedTerminatedNot yet recruiting|StartCompletionToday
Trials (4)
NCTPhaseIndicationStatusNEP
NCT06911553Phase 3EpilepsyRecruiting1538UPDRS
NCT03343567Phase 3FTDTerminated2811CfB
NCT05455573Phase 3FTDCompleted2862Mayo
NCT08641356Phase 3FTDNot yet recr...2636Safety
Competitors (10)
DrugCompanyPhaseTargetMOA
PFE-7550PfizerPhase 3KIF18Ai
PFE-7809PfizerPhase 1DLL3HER2
SotovorutinibPfizerApprovedCGRPant
LLY-8903Eli LillyPreclinicalCD47HER2
BemalucimabBristol-Myers SquibbPhase 1/2SGLT2i
SNY-7254SanofiPhase 2CFTRHER2
TAK-9344TakedaPhase 3CGRPHER2
DSN-791Daiichi SankyoNDA/BLAAuroraAi
VRT-5853Vertex PharmaPhase 3WRNi
ARG-314ArgenxApprovedBTKi