← Pipeline|GEN-IIT-346

GEN-IIT-346

Approved
Source: Trial-derived·Trials: 1
Modality
Radioligand
MOA
CDK2i
Target
GLP-1R
Pathway
PI3K/AKT
Bladder Ca
Development Pipeline
Preclinical
~Sep 2015
~Dec 2016
Phase 1
~Mar 2017
~Jun 2018
Phase 2
~Sep 2018
~Dec 2019
Phase 3
~Mar 2020
~Jun 2021
NDA/BLA
~Sep 2021
~Dec 2022
Approved
Mar 2023
Dec 2031
ApprovedCurrent
NCT07433083
1,609 pts·Bladder Ca
2023-032031-12·Terminated
1,609 total pts1 indication
CompletedCurrentUpcoming
Catalysts (1)
2031-12-035.7y awayPh3 Readout· Bladder Ca
Trial Timeline
2023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
Approved
Termina…
Catalysts
Ph3 Readout
2031-12-03 · 5.7y away
Bladder Ca
Terminated|StartCompletionToday
Trials (1)
NCTPhaseIndicationStatusNEP
NCT07433083ApprovedBladder CaTerminated1609OS
Competitors (10)
DrugCompanyPhaseTargetMOA
PFE-3703PfizerPhase 1/2CDK2CDK2i
PFE-2191PfizerNDA/BLAGLP-1RSHP2i
RiboinavolisibJohnson & JohnsonPhase 2/3GLP-1RMALT1i
TirzepatideEli LillyApprovedGLP-1RGLP-1/GIP Dual Agonist
TirafotisoranRochePhase 2CD38CDK2i
MRK-5413Merck & CoPhase 1GLP-1RVEGFi
ABB-3951AbbViePhase 2/3TNFαCDK2i
AZN-6870AstraZenecaPhase 2/3EGFRCDK2i
VoxacilimabAstraZenecaPhase 1/2GLP-1RPI3Ki
AZN-5171AstraZenecaApprovedGLP-1RGLP-1/GIP