← Pipeline|Surainavolisib

Surainavolisib

NDA/BLA
685-2378
Source: Trial-derived·Trials: 2
Modality
Multispecific
MOA
HPK1i
Target
MALT1
Pathway
Neuroinflam
BCC
Development Pipeline
Preclinical
~May 2014
~Aug 2015
Phase 1
~Nov 2015
~Feb 2017
Phase 2
~May 2017
~Aug 2018
Phase 3
~Nov 2018
~Feb 2020
NDA/BLA
May 2020
Dec 2031
NDA/BLACurrent
NCT05917680
1,082 pts·BCC
2025-092029-02·Completed
NCT03952605
1,273 pts·BCC
2020-052031-12·Active
2,355 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2029-02-172.9y awayPh3 Readout· BCC
2031-12-235.7y awayPh3 Readout· BCC
Trial Timeline
Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
NDA/BLA
Active
NDA/BLA
Complet…
Catalysts
Ph3 Readout
2029-02-17 · 2.9y away
BCC
Ph3 Readout
2031-12-23 · 5.7y away
BCC
ActiveCompleted|StartCompletionToday
Trials (2)
NCTPhaseIndicationStatusNEP
NCT05917680NDA/BLABCCCompleted1082PANSS
NCT03952605NDA/BLABCCActive1273UPCR
Competitors (10)
DrugCompanyPhaseTargetMOA
PFE-1944PfizerNDA/BLAAPOC3HPK1i
JNJ-8232Johnson & JohnsonNDA/BLAMALT1SGLT2i
NVS-6974NovartisPreclinicalCD19HPK1i
ABB-7516AbbViePhase 3PD-L1HPK1i
BMY-7975Bristol-Myers SquibbPhase 1MALT1WRNi
GSK-6516GSKPhase 1/2MALT1PARPi
BemanesiranBioNTechPhase 3PLK4HPK1i
BII-5240BiogenPhase 2/3MALT1HPK1i
ALN-3958AlnylamPhase 2MALT1PARPi
CevisacituzumabAlnylamPreclinicalMALT1SOS1i