← Pipeline|Pemiglumide

Pemiglumide

NDA/BLA
GLE-3455
Source: Trial-derived·Trials: 2
Modality
ADC
MOA
BiTE
Target
AuroraA
Pathway
NF-κB
MM
Development Pipeline
Preclinical
~Oct 2013
~Jan 2015
Phase 1
~Apr 2015
~Jul 2016
Phase 2
~Oct 2016
~Jan 2018
Phase 3
~Apr 2018
~Jul 2019
NDA/BLA
Oct 2019
Sep 2027
NDA/BLACurrent
NCT06738282
209 pts·MM
2019-112026-10·Completed
NCT06167745
518 pts·MM
2019-102027-09·Terminated
727 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (3)
2025-11-025mo agoPh1 Dose Esc· MM
2026-10-237mo awayPh3 Readout· MM
2027-09-011.4y awayPh3 Readout· MM
Trial Timeline
Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q4
NDA/BLA
Termina…
NDA/BLA
Complet…
Catalysts
Ph1 Dose Esc
2025-11-02 · 5mo ago
MM
Ph3 Readout
2026-10-23 · 7mo away
MM
Ph3 Readout
2027-09-01 · 1.4y away
MM
CompletedTerminated|StartCompletionToday
Trials (2)
NCTPhaseIndicationStatusNEP
NCT06738282NDA/BLAMMCompleted209OS
NCT06167745NDA/BLAMMTerminated518PANSS
Competitors (10)
DrugCompanyPhaseTargetMOA
LLY-3251Eli LillyPhase 2MDM2BiTE
ZanutinibBristol-Myers SquibbPhase 2/3APOC3BiTE
MotarapivirGSKPreclinicalAuroraAIL-23i
BAY-8733BayerPreclinicalAuroraABETi
BemarelsinDaiichi SankyoPreclinicalGLP-1RBiTE
DSN-7360Daiichi SankyoApprovedSGLT2BiTE
BNT-8090BioNTechPhase 2AuroraAPD-L1i
BII-8315BiogenNDA/BLACDK2BiTE
ARG-6988ArgenxPreclinicalAuroraACDK2i
GeliglumideSamsung BiologicsPhase 1BiTE