← Pipeline|FRE-IIT-285

FRE-IIT-285

NDA/BLA
Source: Trial-derived·Trials: 1
Modality
Multispecific
MOA
IL-13i
Target
EGFR
Pathway
DDR
PsA
Development Pipeline
Preclinical
~Jul 2016
~Oct 2017
Phase 1
~Jan 2018
~Apr 2019
Phase 2
~Jul 2019
~Oct 2020
Phase 3
~Jan 2021
~Apr 2022
NDA/BLA
Jul 2022
Nov 2027
NDA/BLACurrent
NCT03823893
1,729 pts·PsA
2022-072027-11·Recruiting
1,729 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2027-11-111.6y awayPh3 Readout· PsA
Trial Timeline
Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q4
NDA/BLA
Recruit…
Catalysts
Ph3 Readout
2027-11-11 · 1.6y away
PsA
Recruiting|StartCompletionToday
Trials (1)
NCTPhaseIndicationStatusNEP
NCT03823893NDA/BLAPsARecruiting1729EFS
Competitors (10)
DrugCompanyPhaseTargetMOA
VoxaderotideJohnson & JohnsonNDA/BLAPI3KαIL-13i
RHH-7975RochePhase 3FXIaIL-13i
NVS-8902NovartisPreclinicalTROP-2IL-13i
AZN-6870AstraZenecaPhase 2/3EGFRCDK2i
GozesotorasibBristol-Myers SquibbNDA/BLAHER2IL-13i
BMY-4586Bristol-Myers SquibbPreclinicalKRASG12CIL-13i
TAK-1836TakedaPreclinicalEGFRKIF18Ai
AMG-1919AmgenPhase 2/3CDK2IL-13i
RibozanubrutinibRegeneronPhase 1CDK4/6IL-13i
ZanurapivirNeurocrineNDA/BLAEGFRCD47i