← Pipeline|Nidaglumide

Nidaglumide

Approved
STA-329
Source: Trial-derived·Trials: 3
Modality
Radioligand
MOA
PD-1i
Target
C5
Pathway
Proteasome
MCCIgANFL
Development Pipeline
Preclinical
~Feb 2011
~May 2012
Phase 1
~Aug 2012
~Nov 2013
Phase 2
~Feb 2014
~May 2015
Phase 3
~Aug 2015
~Nov 2016
NDA/BLA
~Feb 2017
~May 2018
Approved
Aug 2018
Sep 2031
ApprovedCurrent
NCT03048338
1,631 pts·IgAN
2020-022030-08·Not yet recruiting
NCT07371961
2,467 pts·IgAN
2018-082031-09·Not yet recruiting
NCT04775382
2,866 pts·MCC
2024-062030-10·Terminated
6,964 total pts2 indications
CompletedCurrentUpcoming
Catalysts (3)
2030-08-014.3y awayPh3 Readout· IgAN
2030-10-144.5y awayPh3 Readout· MCC
2031-09-265.5y awayPh3 Readout· IgAN
Trial Timeline
Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
Approved
Not yet…
Approved
Not yet…
Approved
Termina…
Catalysts
Ph3 Readout
2030-08-01 · 4.3y away
IgAN
Ph3 Readout
2030-10-14 · 4.5y away
MCC
Ph3 Readout
2031-09-26 · 5.5y away
IgAN
TerminatedNot yet recruiting|StartCompletionToday
Trials (3)
NCTPhaseIndicationStatusNEP
NCT03048338ApprovedIgANNot yet recr...1631PFS
NCT07371961ApprovedIgANNot yet recr...2467EDSS
NCT04775382ApprovedMCCTerminated2866ACR20
Competitors (10)
DrugCompanyPhaseTargetMOA
LLY-9749Eli LillyPhase 3C5FGFRi
LLY-1184Eli LillyNDA/BLAC5CD3xCD20
RHH-1546RochePhase 2/3C5CAR-T CD19
GSK-7987GSKPhase 3MDM2PD-1i
BAY-6035BayerPhase 1C5Anti-Aβ
NirabrutinibBioNTechPhase 2/3CDK2PD-1i
ARG-1250ArgenxPhase 2C5GLP-1ag
CevinaritideGenmabPhase 2/3DLL3PD-1i
ElratapinarofHalozymePhase 2C5AHRant
HAL-1232HalozymeApprovedC5SOS1i