← Pipeline|Datoinavolisib

Datoinavolisib

NDA/BLA
CAD-2363
Source: Trial-derived·Trials: 1
Modality
Bispecific Ab
MOA
HPK1i
Target
BCMA
Pathway
Complement
SchizophreniaPSPFTD
Development Pipeline
Preclinical
~Feb 2018
~May 2019
Phase 1
~Aug 2019
~Nov 2020
Phase 2
~Feb 2021
~May 2022
Phase 3
~Aug 2022
~Nov 2023
NDA/BLA
Feb 2024
Jun 2029
NDA/BLACurrent
NCT03684148
1,971 pts·PSP
2024-022029-06·Terminated
1,971 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2029-06-093.2y awayPh3 Readout· PSP
Trial Timeline
2024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3
NDA/BLA
Termina…
Catalysts
Ph3 Readout
2029-06-09 · 3.2y away
PSP
Terminated|StartCompletionToday
Trials (1)
NCTPhaseIndicationStatusNEP
NCT03684148NDA/BLAPSPTerminated1971NT-proBNP
Competitors (10)
DrugCompanyPhaseTargetMOA
PFE-1944PfizerNDA/BLAAPOC3HPK1i
LLY-1956Eli LillyPhase 1/2BCMAFGFRi
NVS-6974NovartisPreclinicalCD19HPK1i
ABB-7516AbbViePhase 3PD-L1HPK1i
ABB-8696AbbViePhase 3BCMAAnti-Aβ
AZN-4015AstraZenecaPreclinicalBCMAPCSK9i
REG-2328RegeneronPhase 1BCMACDK2i
AdagratapinarofVertex PharmaPreclinicalBCMAJAK1i
BemanesiranBioNTechPhase 3PLK4HPK1i
BII-5240BiogenPhase 2/3MALT1HPK1i