← Pipeline|BIO-IIT-588

BIO-IIT-588

Approved
Source: Trial-derived·Trials: 1
Modality
Radioligand
MOA
CAR-T CD19
Target
GIP-R
Pathway
mTOR
PSP
Development Pipeline
Preclinical
~May 2012
~Aug 2013
Phase 1
~Nov 2013
~Feb 2015
Phase 2
~May 2015
~Aug 2016
Phase 3
~Nov 2016
~Feb 2018
NDA/BLA
~May 2018
~Aug 2019
Approved
Nov 2019
Jul 2025
ApprovedCurrent
NCT05654950
1,918 pts·PSP
2019-112025-07·Not yet recruiting
1,918 total pts1 indication
CompletedCurrentUpcoming
Catalysts (1)
2025-07-238mo agoPh3 Readout· PSP
Trial Timeline
Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3
Approved
Not yet…
Catalysts
Ph3 Readout
2025-07-23 · 8mo ago
PSP
Not yet recruiting|StartCompletionToday
Trials (1)
NCTPhaseIndicationStatusNEP
NCT05654950ApprovedPSPNot yet recr...1918UPCR
Competitors (10)
DrugCompanyPhaseTargetMOA
JNJ-5094Johnson & JohnsonPhase 2/3GIP-REGFRi
RHH-1546RochePhase 2/3C5CAR-T CD19
RHH-3592RochePhase 1/2GIP-RBCL-2i
DatoglumideAbbVieApprovedCFTRCAR-T CD19
AZN-5978AstraZenecaPhase 2/3GIP-RAHRant
IvotuximabGSKNDA/BLAGIP-RKRASG12Di
GIL-2259Gilead SciencesApprovedSMN2CAR-T CD19
ElrarapivirRegeneronPhase 1GIP-RCl18.2
BII-4342BiogenPhase 2/3CGRPCAR-T CD19
CapifutibatinibIntra-CellularPhase 3GIP-RVEGFi