← Pipeline|FHT-3384

FHT-3384

NDA/BLA
Source: Trial-derived·Trials: 1
Modality
ADC
MOA
CDK4/6i
Target
JAK2
Pathway
Tau
Urothelial CaFTDParkinson's
Development Pipeline
Preclinical
~Oct 2018
~Jan 2020
Phase 1
~Apr 2020
~Jul 2021
Phase 2
~Oct 2021
~Jan 2023
Phase 3
~Apr 2023
~Jul 2024
NDA/BLA
Oct 2024
Oct 2030
NDA/BLACurrent
NCT04792601
1,477 pts·FTD
2024-102030-10·Completed
1,477 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2030-10-114.5y awayPh3 Readout· FTD
Trial Timeline
Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
NDA/BLA
Complet…
Catalysts
Ph3 Readout
2030-10-11 · 4.5y away
FTD
Completed|StartCompletionToday
Trials (1)
NCTPhaseIndicationStatusNEP
NCT04792601NDA/BLAFTDCompleted1477OS
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
AdagracapivasertibBeiGeneNDA/BLABETCDK4/6i
GMA-5010GenmabPhase 3JAK2TROP-2 ADC
NBI-3153NeurocrineApprovedCDK4/6i