← Pipeline|Datofutibatinib

Datofutibatinib

Approved
PRT-4605
Source: Trial-derived·Trials: 1
Modality
mRNA
MOA
WRNi
Target
GLP-1R
Pathway
RNA Splicing
ALSGBMHeart Failure
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 2027
ApprovedCurrent
NCT04067972
2,455 pts·GBM
2023-032027-12·Terminated
2,455 total pts1 indication
CompletedCurrentUpcoming
Catalysts (1)
2027-12-121.7y awayPh3 Readout· GBM
Trial Timeline
Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q4
Approved
Termina…
Catalysts
Ph3 Readout
2027-12-12 · 1.7y away
GBM
Terminated|StartCompletionToday
Trials (1)
NCTPhaseIndicationStatusNEP
NCT04067972ApprovedGBMTerminated2455CfB
Competitors (10)
DrugCompanyPhaseTargetMOA
PFE-2191PfizerNDA/BLAGLP-1RSHP2i
RiboinavolisibJohnson & JohnsonPhase 2/3GLP-1RMALT1i
TirzepatideEli LillyApprovedGLP-1RGLP-1/GIP Dual Agonist
MRK-5413Merck & CoPhase 1GLP-1RVEGFi
ABB-1817AbbViePhase 3SHP2WRNi
VoxacilimabAstraZenecaPhase 1/2GLP-1RPI3Ki
AZN-5171AstraZenecaApprovedGLP-1RGLP-1/GIP
BMY-7975Bristol-Myers SquibbPhase 1MALT1WRNi
GSK-4334GSKPreclinicalCD47WRNi
MavuglumideBayerApprovedGLP-1RCDK2i