← Pipeline|ITO-535

ITO-535

NDA/BLA
Source: Trial-derived·Trials: 1
Modality
Cell Therapy
MOA
USP1i
Target
MDM2
Pathway
Proteasome
PompeADPKD
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 2031
NDA/BLACurrent
NCT06963354
518 pts·Pompe
2022-072031-11·Recruiting
518 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2031-11-155.6y awayPh3 Readout· Pompe
Trial Timeline
Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
NDA/BLA
Recruit…
Catalysts
Ph3 Readout
2031-11-15 · 5.6y away
Pompe
Recruiting|StartCompletionToday
Trials (1)
NCTPhaseIndicationStatusNEP
NCT06963354NDA/BLAPompeRecruiting518HAM-D
Competitors (10)
DrugCompanyPhaseTargetMOA
LLY-6079Eli LillyPhase 2MDM2PRMT5i
LLY-3251Eli LillyPhase 2MDM2BiTE
SNY-2934SanofiPhase 3KRASG12DUSP1i
GSK-7987GSKPhase 3MDM2PD-1i
AMG-2752AmgenPreclinicalMDM2WRNi
AMG-9052AmgenPhase 2/3CDK2USP1i
REG-3155RegeneronPhase 1/2MDM2PI3Ki
DatozumabRegeneronPhase 1B7-H3USP1i
GMA-729GenmabPhase 2BCL-2USP1i
SRP-1135SareptaPhase 2/3MDM2PD-L1i