← Pipeline|453-4974

453-4974

NDA/BLA
Source: Trial-derived·Trials: 1
Modality
Radioligand
MOA
CDK4/6i
Target
PLK4
Pathway
T-cell
MSMCCPsA
Development Pipeline
Preclinical
~Dec 2019
~Mar 2021
Phase 1
~Jun 2021
~Sep 2022
Phase 2
~Dec 2022
~Mar 2024
Phase 3
~Jun 2024
~Sep 2025
NDA/BLA
Dec 2025
Nov 2027
NDA/BLACurrent
NCT07193018
2,660 pts·MCC
2025-122027-11·Not yet recruiting
2,660 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2027-11-191.6y awayPh3 Readout· MCC
Trial Timeline
2026Q2Q3Q42027Q2Q3Q4
NDA/BLA
Not yet…
Catalysts
Ph3 Readout
2027-11-19 · 1.6y away
MCC
Not yet recruiting|StartCompletionToday
Trials (1)
NCTPhaseIndicationStatusNEP
NCT07193018NDA/BLAMCCNot yet recr...2660SRI-4
Competitors (10)
DrugCompanyPhaseTargetMOA
PFE-5767PfizerPhase 1/2BETCDK4/6i
RHH-1969RocheApprovedBETCDK4/6i
IvocapivasertibBristol-Myers SquibbPhase 1BETCDK4/6i
ZorimavacamtenBristol-Myers SquibbPreclinicalCl18.2CDK4/6i
FixatenlimabGSKPhase 1/2JAK1CDK4/6i
VRT-4938Vertex PharmaPreclinicalHER2CDK4/6i
VRT-5441Vertex PharmaPhase 3GLP-1RCDK4/6i
BemanesiranBioNTechPhase 3PLK4HPK1i
AdagracapivasertibBeiGeneNDA/BLABETCDK4/6i
NBI-3153NeurocrineApprovedCDK4/6i