← Pipeline|ALE-8045

ALE-8045

Phase 1
Source: Trial-derived·Trials: 2
Modality
Bispecific Ab
MOA
SGLT2i
Target
FXIa
Pathway
STING
MGMDD
Development Pipeline
Preclinical
~Oct 2015
~Jan 2017
Phase 1
Apr 2017
Mar 2027
Phase 1Current
NCT06915613
1,213 pts·MG
2024-022027-03·Active
NCT03675787
837 pts·MDD
2017-042027-01·Completed
2,050 total pts2 indications
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2027-01-2810mo awayInterim· MDD
2027-03-0911mo awayInterim· MG
Trial Timeline
Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2
P1
Complet…
P1
Active
Catalysts
Interim
2027-01-28 · 10mo away
MDD
Interim
2027-03-09 · 11mo away
MG
ActiveCompleted|StartCompletionToday
Trials (2)
NCTPhaseIndicationStatusNEP
NCT06915613Phase 1MGActive1213SRI-4
NCT03675787Phase 1MDDCompleted837CR
Competitors (10)
DrugCompanyPhaseTargetMOA
PFE-1085PfizerPreclinicalFXIaPD-L1i
JNJ-8232Johnson & JohnsonNDA/BLAMALT1SGLT2i
RHH-682RochePhase 2FXIaPRMT5i
RHH-7975RochePhase 3FXIaIL-13i
GozelemzoparlimabMerck & CoPhase 2FXIaKRASG12Ci
BemalucimabBristol-Myers SquibbPhase 1/2SGLT2i
PexazasiranSanofiPreclinicalFXIaKRASG12Ci
BAY-3308BayerPhase 1ALKSGLT2i
RimaosocimabAmgenPreclinicalFXIaBCL-2i
GIL-9142Gilead SciencesPhase 1FXIaPRMT5i